Trial Outcomes & Findings for A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf (NCT NCT01265537)
NCT ID: NCT01265537
Last Updated: 2025-01-23
Results Overview
Composite endpoint of biopsy proven acute rejection and NODAT at 6 months post transplantation. NODAT will be defined as either FPG \>7.0mmol/L OR symptoms of hyperglycemia and a random plasma glucose of \>11.1 OR 2-h plasma glucose \>11.1 during an oral glucose tolerance test(OGTT).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
6 months post transplant
Results posted on
2025-01-23
Participant Flow
Participant milestones
| Measure |
Low Target Tacrolimus (Advagraf)
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Low Target Tacrolimus (Advagraf)
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
Baseline characteristics by cohort
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
n=5 Participants
|
50.4 years
n=7 Participants
|
54.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Multiracial
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Family History of Diabetes
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Body Mass Index
|
25.1 kg/m^2
STANDARD_DEVIATION 3.0 • n=5 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Systolic Blood Pressure
|
150 mmHg
STANDARD_DEVIATION 21 • n=5 Participants
|
159 mmHg
STANDARD_DEVIATION 27 • n=7 Participants
|
154 mmHg
STANDARD_DEVIATION 24 • n=5 Participants
|
|
Diastolic Blood Pressure
|
81 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
87 mmHg
STANDARD_DEVIATION 9 • n=7 Participants
|
84 mmHg
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Cholesterol Medications
Yes
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Cholesterol Medications
No
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Cholestoral
|
4.56 mmol/L
STANDARD_DEVIATION 0.97 • n=5 Participants
|
4.43 mmol/L
STANDARD_DEVIATION 0.60 • n=7 Participants
|
4.49 mmol/L
STANDARD_DEVIATION 0.78 • n=5 Participants
|
|
Low-Density Lipoproteins
|
2.72 mmol/L
STANDARD_DEVIATION 0.82 • n=5 Participants
|
2.68 mmol/L
STANDARD_DEVIATION 0.76 • n=7 Participants
|
2.70 mmol/L
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
High-Density Lipoproteins
|
1.21 mmol/L
STANDARD_DEVIATION 0.28 • n=5 Participants
|
1.37 mmol/L
STANDARD_DEVIATION 0.62 • n=7 Participants
|
1.30 mmol/L
STANDARD_DEVIATION 0.49 • n=5 Participants
|
|
Triglycerides
|
1.38 mmol/L
STANDARD_DEVIATION 0.36 • n=5 Participants
|
1.52 mmol/L
STANDARD_DEVIATION 1.08 • n=7 Participants
|
1.46 mmol/L
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Fasting Glucose
|
5.6 mmol/L
STANDARD_DEVIATION 0.8 • n=5 Participants
|
5.2 mmol/L
STANDARD_DEVIATION 0.6 • n=7 Participants
|
5.4 mmol/L
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Random Glucose
|
5.5 mmol/L
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.7 mmol/L
STANDARD_DEVIATION 1.1 • n=7 Participants
|
5.6 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Peak Panel-Reactive Antibody (PRA) before transplant
|
0 %
n=5 Participants
|
0 %
n=7 Participants
|
0 %
n=5 Participants
|
|
Donor Type
Living
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Donor Type
Deceased
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Donor Age
|
41 years
n=5 Participants
|
34 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
0 matches
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
1 match
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
2 matches
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
3 matches
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
4 matches
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
5 matches
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Human Leukocyte Antigen (HLA) Matches
Missing
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Composite endpoint of biopsy proven acute rejection and NODAT at 6 months post transplantation. NODAT will be defined as either FPG \>7.0mmol/L OR symptoms of hyperglycemia and a random plasma glucose of \>11.1 OR 2-h plasma glucose \>11.1 during an oral glucose tolerance test(OGTT).
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Death of any participant by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participant Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any graft failure by the end of the study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With Graft Failure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any dialysis required by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With Dialysis Events
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any infection (CMV, opportunistic infections including urinary tract infections requiring treatment, pneumonia) by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With Infection Events
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any hospitalization by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With Hospitalization Events
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any malignancy (including post-transplant lymphoproliferative disease) by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With Malignancy Events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any cardiovascular events by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Participants With Cardiovascular Event
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any leukopenia by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Any Leukopenia Events
|
11 events
|
3 events
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any leukopenia on ≥2 occasions by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Number of Leukopenia Events on ≥2 Occasions
|
6 events
|
0 events
|
SECONDARY outcome
Timeframe: baseline to 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Any changes in weight by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Change From Baseline in Weight
|
2.8 kg
Interval 0.8 to 6.8
|
1.5 kg
Interval -1.3 to 3.8
|
SECONDARY outcome
Timeframe: 6 months post transplantPopulation: The discrepancy in the overall number of participants with outcome measure data and the overall number of participants in the participant flow module is seen because 28 participants in total have outcome measure data available.
Participant eGFR value by end of study.
Outcome measures
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 Participants
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
eGFR at 6 Months
|
56 mL/min/1.73^2
Interval 51.0 to 81.0
|
51 mL/min/1.73^2
Interval 43.0 to 63.0
|
Adverse Events
Low Target Tacrolimus (Advagraf)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Target Tacrolimus (Advagraf)
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Target Tacrolimus (Advagraf)
n=14 participants at risk
This group will receive rabbit anti-thymocyte globulin (rATG) induction (3 -4 doses of 1.5 mg/kg during the first post transplant week) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "low-target" Advagraf.
Tacrolimus: Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx:
0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4
|
Standard Target Tacrolimus (Advagraf)
n=14 participants at risk
This group will receive basiliximab induction (40 mg total) with IV solumedrol, MPA (Mycophenolate Mofetil or Mycophenolate Sodium), and "standard target" Advagraf.
Tacrolimus: Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
Table 1
Months post tx
0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8.
|
|---|---|---|
|
Renal and urinary disorders
Dialysis
|
14.3%
2/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
14.3%
2/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
|
Renal and urinary disorders
Acute Rejection
|
7.1%
1/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
14.3%
2/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
|
Immune system disorders
Malignancy
|
7.1%
1/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
0.00%
0/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
|
Infections and infestations
Infections
|
35.7%
5/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
35.7%
5/14 • Adverse event data was collected from the baseline visit until 6 months post transplant.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place