Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients (NCT NCT00543569)
NCT ID: NCT00543569
Last Updated: 2015-12-11
Results Overview
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
323 participants
Primary outcome timeframe
6 months
Results posted on
2015-12-11
Participant Flow
This study enrolled de novo kidney transplant recipients who were at least 18 years of age.
Participant milestones
| Measure |
Tacrolimus/MMF/Basiliximab
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
80
|
80
|
81
|
|
Overall Study
Received Treatment
|
79
|
77
|
75
|
78
|
|
Overall Study
COMPLETED
|
70
|
72
|
60
|
72
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
20
|
9
|
Reasons for withdrawal
| Measure |
Tacrolimus/MMF/Basiliximab
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Overall Study
Death
|
2
|
2
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Miscellaneous Reasons
|
7
|
3
|
11
|
4
|
|
Overall Study
Randomized but never received study drug
|
3
|
3
|
5
|
3
|
Baseline Characteristics
A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.44 years
STANDARD_DEVIATION 15.077 • n=5 Participants
|
49.26 years
STANDARD_DEVIATION 13.532 • n=7 Participants
|
47.80 years
STANDARD_DEVIATION 12.469 • n=5 Participants
|
49.68 years
STANDARD_DEVIATION 13.749 • n=4 Participants
|
48.80 years
STANDARD_DEVIATION 13.707 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review
|
12.7 percentage of participants
Interval 6.5 to 18.9
|
26.3 percentage of participants
Interval 18.0 to 34.6
|
18.8 percentage of participants
Interval 11.4 to 26.3
|
16.7 percentage of participants
Interval 9.8 to 23.7
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Patient Survival at Month 6 and Month 12
Month 6
|
96.2 percentage of participants
Interval 92.7 to 99.7
|
94.8 percentage of participants
Interval 90.6 to 99.0
|
97.3 percentage of participants
Interval 94.3 to 100.0
|
93.6 percentage of participants
Interval 89.0 to 98.2
|
|
Patient Survival at Month 6 and Month 12
Month 12
|
87.3 percentage of participants
Interval 81.2 to 93.5
|
92.2 percentage of participants
Interval 87.2 to 97.2
|
87.8 percentage of participants
Interval 81.5 to 94.1
|
89.7 percentage of participants
Interval 84.1 to 95.4
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Graft Survival at Month 6 and Month 12
Month 6
|
96.2 percentage of participants
Interval 92.7 to 99.7
|
93.5 percentage of participants
Interval 88.9 to 98.1
|
96.0 percentage of participants
Interval 92.3 to 99.7
|
92.3 percentage of participants
Interval 87.3 to 97.3
|
|
Graft Survival at Month 6 and Month 12
Month 12
|
87.3 percentage of participants
Interval 81.2 to 93.5
|
90.9 percentage of participants
Interval 85.5 to 96.3
|
86.5 percentage of participants
Interval 79.9 to 93.0
|
85.8 percentage of participants
Interval 79.2 to 92.3
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With BCAR at Month 12 Assessed by Local Review
|
15.4 percentage of participants
Interval 8.6 to 22.1
|
29.0 percentage of participants
Interval 20.4 to 37.6
|
20.2 percentage of participants
Interval 12.5 to 27.9
|
18.1 percentage of participants
Interval 10.9 to 25.3
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
Month 6
|
7.7 percentage of participants
Interval 2.7 to 12.7
|
18.3 percentage of participants
Interval 11.0 to 25.6
|
12.1 percentage of participants
Interval 5.9 to 18.3
|
14.2 percentage of participants
Interval 7.7 to 20.7
|
|
Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review
Month 12
|
7.7 percentage of participants
Interval 2.7 to 12.7
|
19.7 percentage of participants
Interval 12.2 to 27.2
|
12.1 percentage of participants
Interval 5.9 to 18.3
|
15.5 percentage of participants
Interval 8.8 to 22.3
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
Month 6
|
12.7 percentage of participants
Interval 6.5 to 18.9
|
25.0 percentage of participants
Interval 16.8 to 33.1
|
18.8 percentage of participants
Interval 11.4 to 26.3
|
16.7 percentage of participants
Interval 9.8 to 23.7
|
|
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review
Month 12
|
14.0 percentage of participants
Interval 7.6 to 20.5
|
27.7 percentage of participants
Interval 19.2 to 36.1
|
18.8 percentage of participants
Interval 11.4 to 26.3
|
18.1 percentage of participants
Interval 10.9 to 25.3
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review
Month 6
|
7.7 percentage of participants
Interval 2.7 to 12.7
|
17.0 percentage of participants
Interval 9.9 to 24.1
|
12.1 percentage of participants
Interval 5.9 to 18.3
|
14.2 percentage of participants
Interval 7.7 to 20.7
|
|
Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review
Month 12
|
7.7 percentage of participants
Interval 2.7 to 12.7
|
18.4 percentage of participants
Interval 11.1 to 25.7
|
12.1 percentage of participants
Interval 5.9 to 18.3
|
15.5 percentage of participants
Interval 8.8 to 22.3
|
SECONDARY outcome
Timeframe: Week 4, Month 6 and Month 12Population: Full analysis set with available data at Week 4. "N" indicates the number of participants with available data at each time point.
The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=71 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=66 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=70 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=72 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
Week 4
|
54.7 mL/min per 1.73 m^2
Standard Deviation 17.16
|
59.3 mL/min per 1.73 m^2
Standard Deviation 24.01
|
51.6 mL/min per 1.73 m^2
Standard Deviation 19.32
|
58.0 mL/min per 1.73 m^2
Standard Deviation 16.97
|
|
Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
Change at Month 6 (N=65, 66, 67, 66)
|
5.7 mL/min per 1.73 m^2
Standard Deviation 16.44
|
3.2 mL/min per 1.73 m^2
Standard Deviation 13.86
|
8.3 mL/min per 1.73 m^2
Standard Deviation 12.96
|
2.5 mL/min per 1.73 m^2
Standard Deviation 12.82
|
|
Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12
Change at Month 12 (n=66, 64, 64, 66)
|
8.9 mL/min per 1.73 m^2
Standard Deviation 18.88
|
3.3 mL/min per 1.73 m^2
Standard Deviation 16.55
|
9.1 mL/min per 1.73 m^2
Standard Deviation 13.59
|
2.7 mL/min per 1.73 m^2
Standard Deviation 16.60
|
SECONDARY outcome
Timeframe: Week 4 and Month 6Population: Full analysis set with available data at Week 4. "N" indicates participants with available data at Week 4 and Month 6.
The glomerular filtration rate was measured directly using iothalamate clearance.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=59 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=49 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=50 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=55 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Change From Week 4 in GFR by Iothalamate Clearance at Month 6
Week 4
|
48.00 mL/min per 1.73 m^2
Standard Deviation 26.327
|
56.51 mL/min per 1.73 m^2
Standard Deviation 33.612
|
44.36 mL/min per 1.73 m^2
Standard Deviation 19.045
|
52.09 mL/min per 1.73 m^2
Standard Deviation 25.696
|
|
Change From Week 4 in GFR by Iothalamate Clearance at Month 6
Change at Month 6 (N=48, 45, 45, 47)
|
5.81 mL/min per 1.73 m^2
Standard Deviation 24.298
|
3.47 mL/min per 1.73 m^2
Standard Deviation 34.708
|
3.56 mL/min per 1.73 m^2
Standard Deviation 21.104
|
6.60 mL/min per 1.73 m^2
Standard Deviation 35.090
|
SECONDARY outcome
Timeframe: Week 4 and Month 6 and 12Population: Full analysis set with available data at Week 4. "N" indicates participants with available data at each time point.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=73 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=70 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=71 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=74 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Change From Week 4 in Serum Creatinine at Month 6 and 12
Change at Month 6 (N=69, 69, 68, 70)
|
-0.0 mg/dL
Standard Deviation 0.64
|
-0.2 mg/dL
Standard Deviation 1.08
|
-0.3 mg/dL
Standard Deviation 0.64
|
-0.0 mg/dL
Standard Deviation 0.32
|
|
Change From Week 4 in Serum Creatinine at Month 6 and 12
Week 4
|
1.5 mg/dL
Standard Deviation 0.68
|
1.6 mg/dL
Standard Deviation 1.25
|
1.6 mg/dL
Standard Deviation 0.84
|
1.5 mg/dL
Standard Deviation 0.73
|
|
Change From Week 4 in Serum Creatinine at Month 6 and 12
Change at Month 12 (N=67, 67, 65, 68)
|
-0.1 mg/dL
Standard Deviation 0.45
|
-0.2 mg/dL
Standard Deviation 1.24
|
-0.2 mg/dL
Standard Deviation 0.76
|
0.1 mg/dL
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Efficacy failure is defined as death, graft failure (permanent return to dialysis \[\>30 days\] or retransplant), BCAR according to local review, or lost to follow-up.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review
Month 6
|
15.2 percentage of participants
Interval 8.5 to 21.8
|
29.9 percentage of participants
Interval 21.3 to 38.4
|
22.7 percentage of participants
Interval 14.7 to 30.6
|
23.1 percentage of participants
Interval 15.2 to 30.9
|
|
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review
Month 12
|
25.3 percentage of participants
Interval 17.3 to 33.4
|
33.8 percentage of participants
Interval 24.9 to 42.6
|
29.3 percentage of participants
Interval 20.7 to 38.0
|
29.5 percentage of participants
Interval 21.0 to 38.0
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Efficacy failure is defined as death, graft failure (permanent return to dialysis \[\>30 days\] or retransplant), BCAR according to central review, or lost to follow-up.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review
Month 6
|
11.4 percentage of participants
Interval 5.5 to 17.3
|
22.1 percentage of participants
Interval 14.3 to 29.9
|
16.0 percentage of participants
Interval 9.0 to 23.0
|
20.5 percentage of participants
Interval 13.0 to 28.0
|
|
Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review
Month 12
|
19.0 percentage of participants
Interval 11.7 to 26.2
|
26.0 percentage of participants
Interval 17.8 to 34.2
|
21.3 percentage of participants
Interval 13.6 to 29.1
|
25.6 percentage of participants
Interval 17.5 to 33.8
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set with a BCAR assessed by local review
The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=12 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=22 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=15 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=14 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Time to First BCAR Assessed by Local Review
|
9 days
Interval 5.0 to 194.0
|
12 days
Interval 6.0 to 301.0
|
19 days
Interval 7.0 to 195.0
|
12.5 days
Interval 5.0 to 186.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set with a BCAR as assessed by the central reviewer
The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=6 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=15 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=9 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=12 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Time to First BCAR Assessed by Central Review
|
19 days
Interval 6.0 to 142.0
|
10 days
Interval 7.0 to 187.0
|
12 days
Interval 7.0 to 52.0
|
11.5 days
Interval 5.0 to 295.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set with a T-cell mediated BCAR as assessed by local review
The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=11 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=21 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=14 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=14 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Time to First T-cell Mediated BCAR Assessed by Local Review
|
9 days
Interval 5.0 to 194.0
|
12 days
Interval 6.0 to 301.0
|
18 days
Interval 7.0 to 178.0
|
12.5 days
Interval 5.0 to 186.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer
The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=6 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=14 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=9 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=12 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Time to First T-cell Mediated BCAR Assessed by Central Review
|
19 days
Interval 6.0 to 142.0
|
10 days
Interval 7.0 to 187.0
|
12 days
Interval 7.0 to 52.0
|
11.5 days
Interval 5.0 to 295.0
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \>25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 6 - Grade IA
|
4 participants
|
6 participants
|
8 participants
|
2 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 6 - Grade IB
|
3 participants
|
4 participants
|
3 participants
|
4 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 6 - Grade IIA
|
3 participants
|
9 participants
|
3 participants
|
3 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 6 - Grade IIB
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 6 - Grade III
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 12 - Grade IA
|
5 participants
|
6 participants
|
8 participants
|
3 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 12 - Grade IB
|
3 participants
|
5 participants
|
3 participants
|
4 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 12 - Grade IIA
|
3 participants
|
10 participants
|
3 participants
|
3 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 12 - Grade IIB
|
0 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Maximum Grade of T-cell Mediated Rejection Assessed by Local Review
Month 12 - Grade III
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \>25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 6 - Grade IA
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 6 - Grade IB
|
0 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 6 - Grade IIA
|
5 participants
|
6 participants
|
3 participants
|
5 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 6 - Grade IIB
|
0 participants
|
2 participants
|
3 participants
|
4 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 6 - Grade III
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 12 - Grade IA
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 12 - Grade IB
|
0 participants
|
4 participants
|
1 participants
|
2 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 12 - Grade IIA
|
5 participants
|
6 participants
|
3 participants
|
5 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 12 - Grade IIB
|
0 participants
|
2 participants
|
3 participants
|
4 participants
|
|
Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review
Month 12 - Grade III
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12
Month 12
|
20.3 percentage of participants
Interval 12.8 to 27.7
|
35.1 percentage of participants
Interval 26.1 to 44.0
|
30.7 percentage of participants
Interval 21.9 to 39.4
|
23.1 percentage of participants
Interval 15.2 to 30.9
|
|
Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12
Month 6
|
19.0 percentage of participants
Interval 11.7 to 26.2
|
33.8 percentage of participants
Interval 24.9 to 42.6
|
29.3 percentage of participants
Interval 20.7 to 38.0
|
23.1 percentage of participants
Interval 15.2 to 30.9
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol. The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12
Month 6
|
6.3 percentage of participants
Interval 1.8 to 10.8
|
20.8 percentage of participants
Interval 13.2 to 28.4
|
12.0 percentage of participants
Interval 5.8 to 18.2
|
7.7 percentage of participants
Interval 2.7 to 12.7
|
|
Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12
Month 12
|
6.3 percentage of participants
Interval 1.8 to 10.8
|
20.8 percentage of participants
Interval 13.2 to 28.4
|
12.0 percentage of participants
Interval 5.8 to 18.2
|
7.7 percentage of participants
Interval 2.7 to 12.7
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12
Month 6
|
1.3 percentage of participants
Interval 0.0 to 3.3
|
3.9 percentage of participants
Interval 0.3 to 7.5
|
4.0 percentage of participants
Interval 0.3 to 7.7
|
2.6 percentage of participants
Interval 0.0 to 5.5
|
|
Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12
Month 12
|
1.3 percentage of participants
Interval 0.0 to 3.3
|
7.8 percentage of participants
Interval 2.8 to 12.8
|
4.0 percentage of participants
Interval 0.3 to 7.7
|
3.8 percentage of participants
Interval 0.3 to 7.4
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: Full analysis set
Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment Failure at Month 6 and 12
Month 6
|
26.6 percentage of participants
Interval 18.4 to 34.8
|
37.7 percentage of participants
Interval 28.6 to 46.7
|
38.4 percentage of participants
Interval 29.0 to 47.7
|
29.5 percentage of participants
Interval 21.0 to 38.0
|
|
Percentage of Participants With Treatment Failure at Month 6 and 12
Month 12
|
35.5 percentage of participants
Interval 26.6 to 44.4
|
45.5 percentage of participants
Interval 36.1 to 54.8
|
45.2 percentage of participants
Interval 35.7 to 54.8
|
34.7 percentage of participants
Interval 25.8 to 43.6
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, and 12Population: Full analysis set with available data at each time point (indicated by "N")
The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Gastrointestinal Quality of Life Index Score Over Time
Month 6 (N=58, 61, 57, 59)
|
3.05 units on a scale
Standard Deviation 0.589
|
3.26 units on a scale
Standard Deviation 0.450
|
3.24 units on a scale
Standard Deviation 0.491
|
3.17 units on a scale
Standard Deviation 0.456
|
|
Gastrointestinal Quality of Life Index Score Over Time
Month 12 (N=62, 60, 52, 58)
|
3.13 units on a scale
Standard Deviation 0.524
|
3.18 units on a scale
Standard Deviation 0.554
|
3.26 units on a scale
Standard Deviation 0.605
|
3.19 units on a scale
Standard Deviation 0.531
|
|
Gastrointestinal Quality of Life Index Score Over Time
Month 1 (N=63, 60, 59, 58)
|
2.85 units on a scale
Standard Deviation 0.602
|
2.97 units on a scale
Standard Deviation 0.541
|
3.00 units on a scale
Standard Deviation 0.513
|
2.98 units on a scale
Standard Deviation 0.493
|
|
Gastrointestinal Quality of Life Index Score Over Time
Month 3 (N=53, 52, 53, 54)
|
2.96 units on a scale
Standard Deviation 0.595
|
3.29 units on a scale
Standard Deviation 0.441
|
3.11 units on a scale
Standard Deviation 0.516
|
3.16 units on a scale
Standard Deviation 0.442
|
SECONDARY outcome
Timeframe: Months 1, 3, 6, and 12Population: Full analysis set with available data at each time point (indicated by "N")
The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.
Outcome measures
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 Participants
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 Participants
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 Participants
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Gastrointestinal Symptom Rating Scale Scores Over Time
Month 12 (N=63, 65, 53, 65)
|
1.63 units on a scale
Standard Deviation 0.635
|
1.42 units on a scale
Standard Deviation 0.564
|
1.52 units on a scale
Standard Deviation 0.609
|
1.57 units on a scale
Standard Deviation 0.642
|
|
Gastrointestinal Symptom Rating Scale Scores Over Time
Month 1 (N=70, 61, 61, 64)
|
1.72 units on a scale
Standard Deviation 0.665
|
1.43 units on a scale
Standard Deviation 0.490
|
1.59 units on a scale
Standard Deviation 0.674
|
1.48 units on a scale
Standard Deviation 0.491
|
|
Gastrointestinal Symptom Rating Scale Scores Over Time
Month 3 (N=58, 55, 53, 56)
|
1.52 units on a scale
Standard Deviation 0.480
|
1.42 units on a scale
Standard Deviation 0.672
|
1.47 units on a scale
Standard Deviation 0.568
|
1.34 units on a scale
Standard Deviation 0.370
|
|
Gastrointestinal Symptom Rating Scale Scores Over Time
Month 6 (N=63, 67, 62, 63)
|
1.63 units on a scale
Standard Deviation 0.602
|
1.41 units on a scale
Standard Deviation 0.695
|
1.49 units on a scale
Standard Deviation 0.471
|
1.42 units on a scale
Standard Deviation 0.496
|
Adverse Events
Tacrolimus/MMF/Basiliximab
Serious events: 41 serious events
Other events: 79 other events
Deaths: 0 deaths
Alefacept QW/Tacrolimus/MMF
Serious events: 48 serious events
Other events: 77 other events
Deaths: 0 deaths
Alefacept QW/Tacrolimus
Serious events: 40 serious events
Other events: 75 other events
Deaths: 0 deaths
Alefacept QOW/Tacrolimus/MMF
Serious events: 45 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 participants at risk
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 participants at risk
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 participants at risk
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 participants at risk
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
Haemoglobin Decreased
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Immunosuppressant Drug Level Increased
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Liver Function Test Abnormal
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
Urine Output Decreased
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
2.7%
2/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Vascular disorders
Hypotension
|
3.8%
3/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Vascular disorders
Hypertension
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Lymphocele
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Vascular disorders
Renovascular Hypertension
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Vascular disorders
Thrombophlebitis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Urosepsis
|
3.8%
3/79 • 12 months
|
2.6%
2/77 • 12 months
|
2.7%
2/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
2.7%
2/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Infections and infestations
Cytomegalovirus Viraemia
|
1.3%
1/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
2.5%
2/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
2.5%
2/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Polyomavirus-Associated Nephropathy
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Infections and infestations
Pyelonephritis
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
4.0%
3/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cytomegalovirus Infection
|
2.5%
2/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection Staphylococcal
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Abscess
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Arteriovenous Graft Site Infection
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Bacterial Pyelonephritis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
BK Virus Infection
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Catheter Bacteraemia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cellulitis Enterococcal
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cellulitis Of Male External Genital Organ
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cellulitis Staphylococcal
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cervicitis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Clostridial Infection
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cytomegalovirus Gastritis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Disseminated Cryptococcosis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Enterococcal Infection
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Epstein-Barr Viraemia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Escherichia Bacteraemia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Escherichia Infection
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Escherichia Sepsis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Fungal Sepsis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Gangrene
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Helicobacter Gastritis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Herpes Simplex
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Incision Site Abscess
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Intertrigo Candida
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Meningitis Cryptococcal
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Osteomyelitis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Perinephric Abscess
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Peritonitis Bacterial
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pneumonia Herpes Viral
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Retroperitoneal Abscess
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Sepsis Syndrome
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Skin Bacterial Infection
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Ureteritis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection Pseudomonal
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Varicella
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Viral Infection
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Wound Infection Bacterial
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Complications Of Transplanted Kidney
|
8.9%
7/79 • 12 months
|
11.7%
9/77 • 12 months
|
6.7%
5/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
2.5%
2/79 • 12 months
|
3.9%
3/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.3%
1/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Injury, poisoning and procedural complications
Renal Injury
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
2.7%
2/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Injury, poisoning and procedural complications
Perirenal Haematoma
|
2.5%
2/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Urine Leak
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Graft Thrombosis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Renal Lymphocele
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Transplant Failure
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Injury, poisoning and procedural complications
Urinary Anastomotic Leak
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.3%
5/79 • 12 months
|
1.3%
1/77 • 12 months
|
4.0%
3/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
2/79 • 12 months
|
2.6%
2/77 • 12 months
|
2.7%
2/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
2/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/79 • 12 months
|
2.6%
2/77 • 12 months
|
2.7%
2/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
2.7%
2/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Haematoma
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Odynophagia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
2.7%
2/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Renal Vein Thrombosis
|
1.3%
1/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Focal Glomerulosclerosis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Polyuria
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Nephritis Interstitial
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Renal and urinary disorders
Renal Artery Thrombosis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Renal and urinary disorders
Renal Mass
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Renal Vasculitis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Tubulointerstitial Nephritis
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Blood Creatinine Increased
|
5.1%
4/79 • 12 months
|
5.2%
4/77 • 12 months
|
2.7%
2/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Investigations
Histology Abnormal
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
2.5%
2/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
2.7%
2/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Cardiac Tamponade
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Myocardial Ischaemia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Sinus Bradycardia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
2.7%
2/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy Mediastinal
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Blood and lymphatic system disorders
Splenic Infarction
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Pyrexia
|
1.3%
1/79 • 12 months
|
3.9%
3/77 • 12 months
|
2.7%
2/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
General disorders
Chills
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Death
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Haemorrhage
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma Stage Unspecified
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Adenoma
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Anoxic Encephalopathy
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Diabetic Neuropathy
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Unresponsive To Stimuli
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Removal Of Renal Transplant
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Surgical and medical procedures
Arteriovenous Fistula Operation
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Surgical and medical procedures
Pancreas Transplant
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Psychiatric disorders
Mental Status Changes
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Psychiatric disorders
Suicide Attempt
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Hepatobiliary disorders
Bile Duct Stone
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Hepatobiliary disorders
Cholestasis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Reproductive system and breast disorders
Haemorrhagic Ovarian Cyst
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Endocrine disorders
Parathyroid Gland Enlargement
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Immune system disorders
Serum Sickness
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
0.00%
0/75 • 12 months
|
0.00%
0/78 • 12 months
|
Other adverse events
| Measure |
Tacrolimus/MMF/Basiliximab
n=79 participants at risk
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus/MMF
n=77 participants at risk
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
|
Alefacept QW/Tacrolimus
n=75 participants at risk
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
|
Alefacept QOW/Tacrolimus/MMF
n=78 participants at risk
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.2%
31/79 • 12 months
|
32.5%
25/77 • 12 months
|
30.7%
23/75 • 12 months
|
41.0%
32/78 • 12 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.5%
13/79 • 12 months
|
15.6%
12/77 • 12 months
|
16.0%
12/75 • 12 months
|
12.8%
10/78 • 12 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.5%
13/79 • 12 months
|
29.9%
23/77 • 12 months
|
17.3%
13/75 • 12 months
|
20.5%
16/78 • 12 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
3/79 • 12 months
|
1.3%
1/77 • 12 months
|
0.00%
0/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Blood and lymphatic system disorders
Polycythaemia
|
5.1%
4/79 • 12 months
|
3.9%
3/77 • 12 months
|
5.3%
4/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
3/79 • 12 months
|
5.2%
4/77 • 12 months
|
1.3%
1/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
7.6%
6/79 • 12 months
|
2.6%
2/77 • 12 months
|
2.7%
2/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
4.0%
3/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Cardiac disorders
Tachycardia
|
10.1%
8/79 • 12 months
|
16.9%
13/77 • 12 months
|
13.3%
10/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.1%
4/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.8%
3/79 • 12 months
|
14.3%
11/77 • 12 months
|
13.3%
10/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.2%
12/79 • 12 months
|
16.9%
13/77 • 12 months
|
13.3%
10/75 • 12 months
|
15.4%
12/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
3.8%
3/79 • 12 months
|
5.2%
4/77 • 12 months
|
4.0%
3/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.8%
3/79 • 12 months
|
2.6%
2/77 • 12 months
|
4.0%
3/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
54.4%
43/79 • 12 months
|
40.3%
31/77 • 12 months
|
41.3%
31/75 • 12 months
|
47.4%
37/78 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
53.2%
42/79 • 12 months
|
44.2%
34/77 • 12 months
|
40.0%
30/75 • 12 months
|
43.6%
34/78 • 12 months
|
|
Gastrointestinal disorders
Dry Mouth
|
5.1%
4/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
13.9%
11/79 • 12 months
|
13.0%
10/77 • 12 months
|
6.7%
5/75 • 12 months
|
15.4%
12/78 • 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
3/79 • 12 months
|
5.2%
4/77 • 12 months
|
4.0%
3/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
2/79 • 12 months
|
6.5%
5/77 • 12 months
|
5.3%
4/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
12.7%
10/79 • 12 months
|
7.8%
6/77 • 12 months
|
6.7%
5/75 • 12 months
|
9.0%
7/78 • 12 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.8%
3/79 • 12 months
|
6.5%
5/77 • 12 months
|
2.7%
2/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
65.8%
52/79 • 12 months
|
48.1%
37/77 • 12 months
|
52.0%
39/75 • 12 months
|
53.8%
42/78 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
24/79 • 12 months
|
23.4%
18/77 • 12 months
|
20.0%
15/75 • 12 months
|
20.5%
16/78 • 12 months
|
|
General disorders
Asthenia
|
7.6%
6/79 • 12 months
|
6.5%
5/77 • 12 months
|
2.7%
2/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
General disorders
Catheter Site Pain
|
2.5%
2/79 • 12 months
|
5.2%
4/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Chills
|
7.6%
6/79 • 12 months
|
5.2%
4/77 • 12 months
|
5.3%
4/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
General disorders
Fatigue
|
15.2%
12/79 • 12 months
|
20.8%
16/77 • 12 months
|
24.0%
18/75 • 12 months
|
15.4%
12/78 • 12 months
|
|
General disorders
Generalised Oedema
|
3.8%
3/79 • 12 months
|
3.9%
3/77 • 12 months
|
6.7%
5/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
General disorders
Impaired Healing
|
1.3%
1/79 • 12 months
|
2.6%
2/77 • 12 months
|
0.00%
0/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
General disorders
Oedema
|
7.6%
6/79 • 12 months
|
15.6%
12/77 • 12 months
|
9.3%
7/75 • 12 months
|
15.4%
12/78 • 12 months
|
|
General disorders
Oedema Peripheral
|
34.2%
27/79 • 12 months
|
28.6%
22/77 • 12 months
|
37.3%
28/75 • 12 months
|
39.7%
31/78 • 12 months
|
|
General disorders
Pain
|
3.8%
3/79 • 12 months
|
2.6%
2/77 • 12 months
|
5.3%
4/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
General disorders
Pyrexia
|
20.3%
16/79 • 12 months
|
14.3%
11/77 • 12 months
|
21.3%
16/75 • 12 months
|
10.3%
8/78 • 12 months
|
|
Infections and infestations
BK Virus Infection
|
19.0%
15/79 • 12 months
|
20.8%
16/77 • 12 months
|
22.7%
17/75 • 12 months
|
25.6%
20/78 • 12 months
|
|
Infections and infestations
Candiduria
|
0.00%
0/79 • 12 months
|
0.00%
0/77 • 12 months
|
5.3%
4/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Cellulitis
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
4.0%
3/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Infections and infestations
Cytomegalovirus Viraemia
|
3.8%
3/79 • 12 months
|
3.9%
3/77 • 12 months
|
0.00%
0/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
2.5%
2/79 • 12 months
|
5.2%
4/77 • 12 months
|
5.3%
4/75 • 12 months
|
10.3%
8/78 • 12 months
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
6/79 • 12 months
|
14.3%
11/77 • 12 months
|
8.0%
6/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Infections and infestations
Oral Candidiasis
|
6.3%
5/79 • 12 months
|
7.8%
6/77 • 12 months
|
2.7%
2/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Infections and infestations
Sinusitis
|
2.5%
2/79 • 12 months
|
10.4%
8/77 • 12 months
|
6.7%
5/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
20.3%
16/79 • 12 months
|
13.0%
10/77 • 12 months
|
12.0%
9/75 • 12 months
|
10.3%
8/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
8.9%
7/79 • 12 months
|
7.8%
6/77 • 12 months
|
6.7%
5/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
3.8%
3/79 • 12 months
|
7.8%
6/77 • 12 months
|
9.3%
7/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
2.5%
2/79 • 12 months
|
3.9%
3/77 • 12 months
|
5.3%
4/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Injury, poisoning and procedural complications
Complications Of Transplanted Kidney
|
13.9%
11/79 • 12 months
|
23.4%
18/77 • 12 months
|
12.0%
9/75 • 12 months
|
24.4%
19/78 • 12 months
|
|
Injury, poisoning and procedural complications
Incision Site Complication
|
2.5%
2/79 • 12 months
|
5.2%
4/77 • 12 months
|
5.3%
4/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
20.3%
16/79 • 12 months
|
28.6%
22/77 • 12 months
|
29.3%
22/75 • 12 months
|
28.2%
22/78 • 12 months
|
|
Injury, poisoning and procedural complications
Perinephric Collection
|
2.5%
2/79 • 12 months
|
6.5%
5/77 • 12 months
|
5.3%
4/75 • 12 months
|
9.0%
7/78 • 12 months
|
|
Injury, poisoning and procedural complications
Post Procedural Discharge
|
12.7%
10/79 • 12 months
|
13.0%
10/77 • 12 months
|
2.7%
2/75 • 12 months
|
9.0%
7/78 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
5.1%
4/79 • 12 months
|
2.6%
2/77 • 12 months
|
4.0%
3/75 • 12 months
|
9.0%
7/78 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
79.7%
63/79 • 12 months
|
75.3%
58/77 • 12 months
|
68.0%
51/75 • 12 months
|
82.1%
64/78 • 12 months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/79 • 12 months
|
3.9%
3/77 • 12 months
|
1.3%
1/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
19.0%
15/79 • 12 months
|
5.2%
4/77 • 12 months
|
13.3%
10/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
1.3%
1/79 • 12 months
|
3.9%
3/77 • 12 months
|
0.00%
0/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Investigations
Alanine Aminotransferase Increased
|
1.3%
1/79 • 12 months
|
5.2%
4/77 • 12 months
|
1.3%
1/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
7.6%
6/79 • 12 months
|
3.9%
3/77 • 12 months
|
2.7%
2/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Investigations
Blood Creatinine Increased
|
20.3%
16/79 • 12 months
|
26.0%
20/77 • 12 months
|
30.7%
23/75 • 12 months
|
29.5%
23/78 • 12 months
|
|
Investigations
Blood Magnesium Decreased
|
3.8%
3/79 • 12 months
|
0.00%
0/77 • 12 months
|
2.7%
2/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Investigations
Blood Urea Increased
|
1.3%
1/79 • 12 months
|
5.2%
4/77 • 12 months
|
2.7%
2/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Investigations
CD4 Lymphocytes Decreased
|
0.00%
0/79 • 12 months
|
10.4%
8/77 • 12 months
|
4.0%
3/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
1.3%
1/79 • 12 months
|
5.2%
4/77 • 12 months
|
1.3%
1/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Immunosuppressant Drug Level Increased
|
6.3%
5/79 • 12 months
|
6.5%
5/77 • 12 months
|
4.0%
3/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Investigations
Liver Function Test Abnormal
|
5.1%
4/79 • 12 months
|
3.9%
3/77 • 12 months
|
4.0%
3/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Investigations
Transaminases Increased
|
6.3%
5/79 • 12 months
|
1.3%
1/77 • 12 months
|
4.0%
3/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Investigations
Urine Output Decreased
|
2.5%
2/79 • 12 months
|
6.5%
5/77 • 12 months
|
4.0%
3/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Investigations
Vitamin D Decreased
|
2.5%
2/79 • 12 months
|
6.5%
5/77 • 12 months
|
2.7%
2/75 • 12 months
|
0.00%
0/78 • 12 months
|
|
Investigations
Weight Increased
|
11.4%
9/79 • 12 months
|
9.1%
7/77 • 12 months
|
12.0%
9/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Investigations
White Blood Cell Count Increased
|
5.1%
4/79 • 12 months
|
1.3%
1/77 • 12 months
|
4.0%
3/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.8%
3/79 • 12 months
|
7.8%
6/77 • 12 months
|
4.0%
3/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
3/79 • 12 months
|
3.9%
3/77 • 12 months
|
6.7%
5/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
15.2%
12/79 • 12 months
|
24.7%
19/77 • 12 months
|
13.3%
10/75 • 12 months
|
20.5%
16/78 • 12 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
10.1%
8/79 • 12 months
|
16.9%
13/77 • 12 months
|
13.3%
10/75 • 12 months
|
17.9%
14/78 • 12 months
|
|
Metabolism and nutrition disorders
Fluid Retention
|
3.8%
3/79 • 12 months
|
6.5%
5/77 • 12 months
|
10.7%
8/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
11.4%
9/79 • 12 months
|
7.8%
6/77 • 12 months
|
9.3%
7/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.1%
4/79 • 12 months
|
2.6%
2/77 • 12 months
|
4.0%
3/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
39.2%
31/79 • 12 months
|
40.3%
31/77 • 12 months
|
38.7%
29/75 • 12 months
|
37.2%
29/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
34.2%
27/79 • 12 months
|
32.5%
25/77 • 12 months
|
38.7%
29/75 • 12 months
|
41.0%
32/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
13.9%
11/79 • 12 months
|
9.1%
7/77 • 12 months
|
10.7%
8/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
8.9%
7/79 • 12 months
|
9.1%
7/77 • 12 months
|
8.0%
6/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
3/79 • 12 months
|
3.9%
3/77 • 12 months
|
5.3%
4/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
17.7%
14/79 • 12 months
|
26.0%
20/77 • 12 months
|
18.7%
14/75 • 12 months
|
32.1%
25/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.3%
5/79 • 12 months
|
9.1%
7/77 • 12 months
|
6.7%
5/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.3%
16/79 • 12 months
|
35.1%
27/77 • 12 months
|
20.0%
15/75 • 12 months
|
33.3%
26/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.6%
40/79 • 12 months
|
41.6%
32/77 • 12 months
|
50.7%
38/75 • 12 months
|
56.4%
44/78 • 12 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.3%
5/79 • 12 months
|
10.4%
8/77 • 12 months
|
8.0%
6/75 • 12 months
|
12.8%
10/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
40.5%
32/79 • 12 months
|
50.6%
39/77 • 12 months
|
48.0%
36/75 • 12 months
|
48.7%
38/78 • 12 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.1%
4/79 • 12 months
|
6.5%
5/77 • 12 months
|
4.0%
3/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
13.9%
11/79 • 12 months
|
15.6%
12/77 • 12 months
|
5.3%
4/75 • 12 months
|
9.0%
7/78 • 12 months
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
19.0%
15/79 • 12 months
|
9.1%
7/77 • 12 months
|
12.0%
9/75 • 12 months
|
9.0%
7/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.9%
11/79 • 12 months
|
9.1%
7/77 • 12 months
|
16.0%
12/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.7%
10/79 • 12 months
|
11.7%
9/77 • 12 months
|
17.3%
13/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/79 • 12 months
|
3.9%
3/77 • 12 months
|
4.0%
3/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
11.4%
9/79 • 12 months
|
11.7%
9/77 • 12 months
|
4.0%
3/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
3.8%
3/79 • 12 months
|
1.3%
1/77 • 12 months
|
9.3%
7/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/79 • 12 months
|
3.9%
3/77 • 12 months
|
2.7%
2/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
5/79 • 12 months
|
7.8%
6/77 • 12 months
|
4.0%
3/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
7.6%
6/79 • 12 months
|
5.2%
4/77 • 12 months
|
9.3%
7/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
6.3%
5/79 • 12 months
|
10.4%
8/77 • 12 months
|
18.7%
14/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Nervous system disorders
Dizziness
|
15.2%
12/79 • 12 months
|
14.3%
11/77 • 12 months
|
16.0%
12/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Nervous system disorders
Headache
|
25.3%
20/79 • 12 months
|
20.8%
16/77 • 12 months
|
22.7%
17/75 • 12 months
|
15.4%
12/78 • 12 months
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
2/79 • 12 months
|
6.5%
5/77 • 12 months
|
5.3%
4/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Nervous system disorders
Lethargy
|
3.8%
3/79 • 12 months
|
3.9%
3/77 • 12 months
|
0.00%
0/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
3.8%
3/79 • 12 months
|
5.2%
4/77 • 12 months
|
6.7%
5/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Nervous system disorders
Tremor
|
43.0%
34/79 • 12 months
|
23.4%
18/77 • 12 months
|
46.7%
35/75 • 12 months
|
25.6%
20/78 • 12 months
|
|
Psychiatric disorders
Agitation
|
1.3%
1/79 • 12 months
|
0.00%
0/77 • 12 months
|
5.3%
4/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Psychiatric disorders
Anxiety
|
7.6%
6/79 • 12 months
|
11.7%
9/77 • 12 months
|
10.7%
8/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
Psychiatric disorders
Depression
|
10.1%
8/79 • 12 months
|
5.2%
4/77 • 12 months
|
6.7%
5/75 • 12 months
|
7.7%
6/78 • 12 months
|
|
Psychiatric disorders
Insomnia
|
32.9%
26/79 • 12 months
|
28.6%
22/77 • 12 months
|
38.7%
29/75 • 12 months
|
25.6%
20/78 • 12 months
|
|
Renal and urinary disorders
Bladder Spasm
|
6.3%
5/79 • 12 months
|
3.9%
3/77 • 12 months
|
2.7%
2/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Renal and urinary disorders
Dysuria
|
11.4%
9/79 • 12 months
|
7.8%
6/77 • 12 months
|
16.0%
12/75 • 12 months
|
10.3%
8/78 • 12 months
|
|
Renal and urinary disorders
Haematuria
|
10.1%
8/79 • 12 months
|
10.4%
8/77 • 12 months
|
10.7%
8/75 • 12 months
|
11.5%
9/78 • 12 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/79 • 12 months
|
3.9%
3/77 • 12 months
|
2.7%
2/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Renal and urinary disorders
Nocturia
|
2.5%
2/79 • 12 months
|
5.2%
4/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Renal and urinary disorders
Oliguria
|
5.1%
4/79 • 12 months
|
0.00%
0/77 • 12 months
|
5.3%
4/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Renal and urinary disorders
Pollakiuria
|
5.1%
4/79 • 12 months
|
5.2%
4/77 • 12 months
|
4.0%
3/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Renal and urinary disorders
Proteinuria
|
8.9%
7/79 • 12 months
|
7.8%
6/77 • 12 months
|
13.3%
10/75 • 12 months
|
10.3%
8/78 • 12 months
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
2.5%
2/79 • 12 months
|
9.1%
7/77 • 12 months
|
6.7%
5/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
1.3%
1/79 • 12 months
|
5.2%
4/77 • 12 months
|
5.3%
4/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/79 • 12 months
|
3.9%
3/77 • 12 months
|
4.0%
3/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
7.6%
6/79 • 12 months
|
5.2%
4/77 • 12 months
|
4.0%
3/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
3.8%
3/79 • 12 months
|
5.2%
4/77 • 12 months
|
0.00%
0/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.8%
3/79 • 12 months
|
2.6%
2/77 • 12 months
|
1.3%
1/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
15/79 • 12 months
|
18.2%
14/77 • 12 months
|
13.3%
10/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
12/79 • 12 months
|
18.2%
14/77 • 12 months
|
18.7%
14/75 • 12 months
|
17.9%
14/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
3.8%
3/79 • 12 months
|
1.3%
1/77 • 12 months
|
5.3%
4/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.8%
3/79 • 12 months
|
6.5%
5/77 • 12 months
|
2.7%
2/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.1%
4/79 • 12 months
|
7.8%
6/77 • 12 months
|
18.7%
14/75 • 12 months
|
14.1%
11/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.5%
2/79 • 12 months
|
1.3%
1/77 • 12 months
|
1.3%
1/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/79 • 12 months
|
2.6%
2/77 • 12 months
|
2.7%
2/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
2/79 • 12 months
|
5.2%
4/77 • 12 months
|
2.7%
2/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
3.8%
3/79 • 12 months
|
5.2%
4/77 • 12 months
|
9.3%
7/75 • 12 months
|
1.3%
1/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.9%
7/79 • 12 months
|
3.9%
3/77 • 12 months
|
8.0%
6/75 • 12 months
|
3.8%
3/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.6%
6/79 • 12 months
|
9.1%
7/77 • 12 months
|
5.3%
4/75 • 12 months
|
10.3%
8/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
1.3%
1/79 • 12 months
|
3.9%
3/77 • 12 months
|
5.3%
4/75 • 12 months
|
2.6%
2/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.5%
13/79 • 12 months
|
19.5%
15/77 • 12 months
|
20.0%
15/75 • 12 months
|
17.9%
14/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.3%
5/79 • 12 months
|
2.6%
2/77 • 12 months
|
8.0%
6/75 • 12 months
|
6.4%
5/78 • 12 months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.5%
2/79 • 12 months
|
0.00%
0/77 • 12 months
|
4.0%
3/75 • 12 months
|
5.1%
4/78 • 12 months
|
|
Vascular disorders
Hypertension
|
44.3%
35/79 • 12 months
|
41.6%
32/77 • 12 months
|
38.7%
29/75 • 12 months
|
39.7%
31/78 • 12 months
|
|
Vascular disorders
Hypotension
|
15.2%
12/79 • 12 months
|
19.5%
15/77 • 12 months
|
16.0%
12/75 • 12 months
|
19.2%
15/78 • 12 months
|
|
Vascular disorders
Orthostatic Hypotension
|
8.9%
7/79 • 12 months
|
1.3%
1/77 • 12 months
|
4.0%
3/75 • 12 months
|
10.3%
8/78 • 12 months
|
Additional Information
Global Head Global Medical Sciences--Transplant and Immunology/Inflammation
Astellas Pharma Global Development, Inc. (APGD)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Standard Restriction Description: Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or 12 months after data-lock, whichever is first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER