Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients (NCT NCT00617604)
NCT ID: NCT00617604
Last Updated: 2016-02-04
Results Overview
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: * Grade IA: significant interstitial infiltration (\>25% parenchyma affected) and foci of moderate tubulitis; * Grade IB: significant interstitial infiltration (\>25% parenchyma affected) and foci of severe tubulitis; * Grade IIA: mild to moderate intimal arteritis; * Grade IIB: severe intimal arteritis comprising \>25% of the luminal area; * Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
COMPLETED
PHASE2
218 participants
6 months
2016-02-04
Participant Flow
Of 221 patients screened, 218 patients were enrolled into the study at 30 centers across 12 countries.
Participant milestones
| Measure |
Placebo
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
108
|
|
Overall Study
Received Treatment
|
107
|
105
|
|
Overall Study
Completed 12 Weeks of Treatment
|
89
|
83
|
|
Overall Study
COMPLETED
|
92
|
88
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Miscellaneous Reasons
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
|
Overall Study
Randomized but Never Received Study Drug
|
3
|
3
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
44.2 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
45.4 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug)
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: * Grade IA: significant interstitial infiltration (\>25% parenchyma affected) and foci of moderate tubulitis; * Grade IB: significant interstitial infiltration (\>25% parenchyma affected) and foci of severe tubulitis; * Grade IIA: mild to moderate intimal arteritis; * Grade IIB: severe intimal arteritis comprising \>25% of the luminal area; * Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review
|
6.7 percentage of participants
Interval 2.7 to 10.7
|
10.6 percentage of participants
Interval 5.6 to 15.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification: Acute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated): * Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation; * Grade II: capillary-margination and/or thromboses, C4d+ * Grade III: arterial - v3, C4d+. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6
|
2.9 percentage of participants
Interval 0.2 to 5.5
|
3.8 percentage of participants
Interval 0.7 to 6.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6
|
9.3 percentage of participants
Interval 4.7 to 14.0
|
12.4 percentage of participants
Interval 7.1 to 17.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6
|
0.0 percentage of participants
Interval 0.0 to 0.0
|
1.0 percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6
|
27.4 percentage of participants
Interval 20.3 to 34.6
|
22.3 percentage of participants
Interval 15.6 to 29.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Clinically Treated Acute Rejection at Month 6
|
24.8 percentage of participants
Interval 17.9 to 31.7
|
15.4 percentage of participants
Interval 9.6 to 21.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category. The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Steroid-resistant Acute Rejection at Month 6
|
7.6 percentage of participants
Interval 3.4 to 11.9
|
5.7 percentage of participants
Interval 2.0 to 9.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1. The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6
|
9.6 percentage of participants
Interval 4.8 to 14.3
|
7.7 percentage of participants
Interval 3.4 to 12.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Patient Survival
|
97.1 percentage of participants
Interval 94.4 to 99.8
|
99.0 percentage of participants
Interval 97.3 to 100.0
|
SECONDARY outcome
Timeframe: 6 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. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information. The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Graft Survival
|
90.6 percentage of participants
Interval 86.0 to 95.3
|
95.2 percentage of participants
Interval 91.7 to 98.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used. Acute T-cell mediated rejection: * Grade IA: significant interstitial infiltration (\>25% parenchyma affected) and foci of moderate tubulitis; * Grade IB: significant interstitial infiltration (\>25% parenchyma affected) and foci of severe tubulitis; * Grade IIA: mild to moderate intimal arteritis; * Grade IIB: severe intimal arteritis comprising \>25% of the luminal area; * Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation. Acute antibody-mediated rejection: * Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation; * Grade II: capillary-margination and/or thromboses, C4d+ * Grade III: arterial - v3, C4d+.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Maximum Histological Grade of All Biopsies After Local Review
T-Cell Mediated Rejection - No Event
|
93.5 percentage of participants
|
89.5 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
T-Cell Mediated Rejection - Grade IA
|
2.8 percentage of participants
|
1.9 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
T-Cell Mediated Rejection - Grade IB
|
0.0 percentage of participants
|
1.0 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
T-Cell Mediated Rejection - Grade IIA
|
1.9 percentage of participants
|
4.8 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
T-Cell Mediated Rejection - Grade IIB
|
1.9 percentage of participants
|
2.9 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
T-Cell Mediated Rejection - Grade III
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
Antibody Mediated Rejection - No Event
|
97.2 percentage of participants
|
96.2 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
Antibody Mediated Rejection - Grade I
|
2.8 percentage of participants
|
1.9 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
Antibody Mediated Rejection - Grade II
|
0.0 percentage of participants
|
1.9 percentage of participants
|
|
Maximum Histological Grade of All Biopsies After Local Review
Antibody Mediated Rejection - Grade III
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6
|
4.7 percentage of participants
Interval 1.3 to 8.2
|
6.7 percentage of participants
Interval 2.7 to 10.7
|
SECONDARY outcome
Timeframe: Month 1, 3, and 6Population: Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by "n").
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=94 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Change From Month 1 in Serum Creatinine
Change From Month 1 to Month 3 (n=94, 88)
|
-5.0125 µmol/L
Standard Deviation 37.97017
|
-5.0830 µmol/L
Standard Deviation 66.25416
|
|
Change From Month 1 in Serum Creatinine
Change From Month 1 to Month 6 (n=86, 81)
|
-6.1777 µmol/L
Standard Deviation 41.57056
|
-11.7212 µmol/L
Standard Deviation 76.19852
|
SECONDARY outcome
Timeframe: Month 1, 3, and 6Population: Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by "n").
The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=93 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Change From Month 1 in Glomerular Filtration Rate (GFR)
Change From Month 1 to Month 3 (n=93, 87)
|
3.1548 mL/min/1.73 m²
Standard Deviation 13.59730
|
0.2889 mL/min/1.73 m²
Standard Deviation 12.54716
|
|
Change From Month 1 in Glomerular Filtration Rate (GFR)
Change From Month 1 to Month 6 (n=83, 78)
|
2.4275 mL/min/1.73 m²
Standard Deviation 15.79533
|
2.5444 mL/min/1.73 m²
Standard Deviation 13.06726
|
SECONDARY outcome
Timeframe: Month 1, 3, and 6Population: Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by "n").
The creatinine clearance was calculated according to the Cockcroft-Gault formula.
Outcome measures
| Measure |
Placebo
n=90 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=84 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Change From Month 1 in Creatinine Clearance
Change From Month 1 to Month 3 (n=81, 79)
|
3.0336 mL/minute
Standard Deviation 13.97651
|
-0.5849 mL/minute
Standard Deviation 12.95160
|
|
Change From Month 1 in Creatinine Clearance
Change From Month 1 to Month 6 (n=77, 73)
|
4.5388 mL/minute
Standard Deviation 17.56456
|
3.0227 mL/minute
Standard Deviation 13.25005
|
SECONDARY outcome
Timeframe: Month 6Population: Full analysis set participants with available data
GFR measured using the iothalamate clearance method and determined by a central laboratory.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=62 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
GFR Measured by Iothalamate Clearance at Month 6
|
59.6029 mL/minute
Standard Deviation 31.36836
|
55.1613 mL/minute
Standard Deviation 26.46383
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up. The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Efficacy Failure at Month 6
|
15.0 percentage of participants
Interval 9.3 to 20.6
|
21.0 percentage of participants
Interval 14.4 to 27.5
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Full analysis set
Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Delayed Graft Function
|
12.1 percentage of participants
|
7.6 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Full analysis set
Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Percentage of Participants With Treatment Failure at Month 6
|
20.6 percentage of participants
Interval 14.1 to 27.0
|
25.7 percentage of participants
Interval 18.7 to 32.7
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Safety analysis set (all randomized participants who received at least one dose of study drug).
Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Resulted in persistent or significant disability/incapacity. * Resulted in congenital anomaly or birth defect. * Required patient hospitalization or led to prolongation of hospitalization * Was considered a medically important event. All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE
Outcome measures
| Measure |
Placebo
n=107 Participants
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 Participants
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Number of Participants With Adverse Events
Any adverse event
|
102 participants
|
101 participants
|
|
Number of Participants With Adverse Events
AE causally related to alefacept/placebo
|
36 participants
|
41 participants
|
|
Number of Participants With Adverse Events
AE causally related to MMF
|
56 participants
|
56 participants
|
|
Number of Participants With Adverse Events
AE causally related to tacrolimus
|
49 participants
|
49 participants
|
|
Number of Participants With Adverse Events
AE causally related to steroids
|
46 participants
|
46 participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
62 participants
|
57 participants
|
|
Number of Participants With Adverse Events
SAE causally related to alefacept/placebo
|
19 participants
|
16 participants
|
|
Number of Participants With Adverse Events
SAE causally related to MMF
|
19 participants
|
21 participants
|
|
Number of Participants With Adverse Events
SAE causally related to tacrolimus
|
14 participants
|
20 participants
|
|
Number of Participants With Adverse Events
SAE causally related to steroids
|
11 participants
|
15 participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of alefacept/placebo
|
7 participants
|
10 participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of MMF
|
8 participants
|
6 participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of tacrolimus
|
8 participants
|
3 participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of steroids
|
1 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Deaths
|
3 participants
|
1 participants
|
Adverse Events
Placebo
Alefacept
Serious adverse events
| Measure |
Placebo
n=107 participants at risk
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 participants at risk
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Infections and infestations
Cytomegalovirus infection
|
5.6%
6/107 • 6 months
|
8.6%
9/105 • 6 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Infections and infestations
Bk virus infection
|
7.5%
8/107 • 6 months
|
2.9%
3/105 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
5.6%
6/107 • 6 months
|
1.9%
2/105 • 6 months
|
|
Infections and infestations
Pyelonephritis acute
|
1.9%
2/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Urosepsis
|
1.9%
2/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Epstein-barr virus infection
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Orchitis
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Renal abscess
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Wound abscess
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Infections and infestations
Polyomavirus-associated nephropathy
|
1.9%
2/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Septic shock
|
1.9%
2/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Erythema infectiosum
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Kidney infection
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Mastitis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Pneumonia
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Renal cyst infection
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Sepsis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Tuberculosis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Renal and urinary disorders
Renal impairment
|
7.5%
8/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Renal and urinary disorders
Renal failure acute
|
0.93%
1/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.8%
3/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Renal ischaemia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
7.5%
8/107 • 6 months
|
7.6%
8/105 • 6 months
|
|
Injury, poisoning and procedural complications
Chronic allograft nephropathy
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Graft loss
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
3.7%
4/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Injury, poisoning and procedural complications
Transplant failure
|
1.9%
2/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Injury, poisoning and procedural complications
Perinephric collection
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Injury, poisoning and procedural complications
Urinary anastomotic leak
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Investigations
Histology abnormal
|
10.3%
11/107 • 6 months
|
5.7%
6/105 • 6 months
|
|
Investigations
Blood creatinine increased
|
3.7%
4/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Investigations
Blood creatine increased
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Investigations
Haematocrit decreased
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Investigations
Weight decreased
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
2/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Gastrointestinal disorders
Periodontitis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma malignant
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Vascular disorders
Lymphocele
|
1.9%
2/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Vascular disorders
Haematoma
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Vascular disorders
Iliac artery stenosis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
General disorders
Pyrexia
|
1.9%
2/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
General disorders
Chest pain
|
1.9%
2/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
General disorders
Drug intolerance
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
General disorders
Face oedema
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
General disorders
Generalised oedema
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Cardiac disorders
Myocardial infarction
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Cardiac disorders
Angina pectoris
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.93%
1/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/107 • 6 months
|
0.95%
1/105 • 6 months
|
|
Reproductive system and breast disorders
Epididymitis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Psychiatric disorders
Mental disorder
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.93%
1/107 • 6 months
|
0.00%
0/105 • 6 months
|
Other adverse events
| Measure |
Placebo
n=107 participants at risk
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
|
Alefacept
n=105 participants at risk
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.5%
54/107 • 6 months
|
40.0%
42/105 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.0%
15/107 • 6 months
|
13.3%
14/105 • 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.5%
7/107 • 6 months
|
4.8%
5/105 • 6 months
|
|
Cardiac disorders
Tachycardia
|
0.93%
1/107 • 6 months
|
5.7%
6/105 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
4/107 • 6 months
|
6.7%
7/105 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
3/107 • 6 months
|
7.6%
8/105 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
18.7%
20/107 • 6 months
|
18.1%
19/105 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
27.1%
29/107 • 6 months
|
23.8%
25/105 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
6.5%
7/107 • 6 months
|
9.5%
10/105 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
7/107 • 6 months
|
7.6%
8/105 • 6 months
|
|
General disorders
Oedema peripheral
|
13.1%
14/107 • 6 months
|
8.6%
9/105 • 6 months
|
|
General disorders
Pyrexia
|
8.4%
9/107 • 6 months
|
8.6%
9/105 • 6 months
|
|
Infections and infestations
Urinary tract infection
|
23.4%
25/107 • 6 months
|
24.8%
26/105 • 6 months
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
11.2%
12/107 • 6 months
|
9.5%
10/105 • 6 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.6%
6/107 • 6 months
|
2.9%
3/105 • 6 months
|
|
Investigations
Blood creatinine increased
|
7.5%
8/107 • 6 months
|
9.5%
10/105 • 6 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
12.1%
13/107 • 6 months
|
12.4%
13/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.5%
7/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.1%
14/107 • 6 months
|
16.2%
17/105 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.3%
10/107 • 6 months
|
9.5%
10/105 • 6 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.5%
7/107 • 6 months
|
5.7%
6/105 • 6 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.5%
7/107 • 6 months
|
4.8%
5/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.5%
7/107 • 6 months
|
5.7%
6/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.9%
17/107 • 6 months
|
14.3%
15/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.6%
6/107 • 6 months
|
6.7%
7/105 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.5%
8/107 • 6 months
|
1.9%
2/105 • 6 months
|
|
Nervous system disorders
Headache
|
3.7%
4/107 • 6 months
|
6.7%
7/105 • 6 months
|
|
Nervous system disorders
Tremor
|
7.5%
8/107 • 6 months
|
15.2%
16/105 • 6 months
|
|
Psychiatric disorders
Anxiety
|
6.5%
7/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Psychiatric disorders
Insomnia
|
11.2%
12/107 • 6 months
|
10.5%
11/105 • 6 months
|
|
Renal and urinary disorders
Dysuria
|
6.5%
7/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Renal and urinary disorders
Renal impairment
|
7.5%
8/107 • 6 months
|
8.6%
9/105 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
6/107 • 6 months
|
3.8%
4/105 • 6 months
|
|
Vascular disorders
Hypertension
|
17.8%
19/107 • 6 months
|
23.8%
25/105 • 6 months
|
|
Vascular disorders
Lymphocele
|
7.5%
8/107 • 6 months
|
1.9%
2/105 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 temporarily to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER