Trial Outcomes & Findings for Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation (NCT NCT01002339)
NCT ID: NCT01002339
Last Updated: 2024-10-22
Results Overview
American Diabetes Association criteria (ADA) including an oral glucose tolerance test.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
134 participants
Primary outcome timeframe
1 year
Results posted on
2024-10-22
Participant Flow
February 2010
Participant milestones
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
Cyclosporin A (CsA) With Steroid Minimization
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
47
|
|
Overall Study
COMPLETED
|
44
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
5
|
Reasons for withdrawal
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
Cyclosporin A (CsA) With Steroid Minimization
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Incorrect treatment assignment
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
|
Overall Study
Lung cancer detected before transplant
|
0
|
0
|
1
|
|
Overall Study
Randomized. Not transplanted
|
0
|
0
|
1
|
Baseline Characteristics
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
Baseline characteristics by cohort
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=44 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=42 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=42 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.2 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
61.6 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
60.2 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
61.0 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
93 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
44 participants
n=99 Participants
|
42 participants
n=107 Participants
|
42 participants
n=206 Participants
|
128 participants
n=7 Participants
|
|
Familiar history of diabetes (N)
Yes
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Familiar history of diabetes (N)
No
|
35 participants
n=99 Participants
|
29 participants
n=107 Participants
|
30 participants
n=206 Participants
|
94 participants
n=7 Participants
|
|
Familiar history of diabetes (N)
Not available
|
6 participants
n=99 Participants
|
9 participants
n=107 Participants
|
3 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Body Mass Index (BMI)
|
26.95 kg/m^2
STANDARD_DEVIATION 3.71 • n=99 Participants
|
27.87 kg/m^2
STANDARD_DEVIATION 3.72 • n=107 Participants
|
27.94 kg/m^2
STANDARD_DEVIATION 4.08 • n=206 Participants
|
27.57 kg/m^2
STANDARD_DEVIATION 3.84 • n=7 Participants
|
|
Time in dialysis
|
37.86 months
STANDARD_DEVIATION 29.97 • n=99 Participants
|
28.61 months
STANDARD_DEVIATION 23.61 • n=107 Participants
|
32.95 months
STANDARD_DEVIATION 26.16 • n=206 Participants
|
33.22 months
STANDARD_DEVIATION 26.82 • n=7 Participants
|
|
Glycated hemoglobin
|
5.27 percentage
STANDARD_DEVIATION 0.51 • n=99 Participants
|
5.37 percentage
STANDARD_DEVIATION 0.32 • n=107 Participants
|
5.31 percentage
STANDARD_DEVIATION 0.43 • n=206 Participants
|
5.31 percentage
STANDARD_DEVIATION 0.43 • n=7 Participants
|
|
Triglycerides levels
|
184.26 mg/dl
STANDARD_DEVIATION 114.93 • n=99 Participants
|
199.31 mg/dl
STANDARD_DEVIATION 91.99 • n=107 Participants
|
209.69 mg/dl
STANDARD_DEVIATION 109.01 • n=206 Participants
|
197.60 mg/dl
STANDARD_DEVIATION 105.83 • n=7 Participants
|
|
Total cholesterol
|
165.86 mg/dl
STANDARD_DEVIATION 47.99 • n=99 Participants
|
162.82 mg/dl
STANDARD_DEVIATION 39.29 • n=107 Participants
|
179.37 mg/dl
STANDARD_DEVIATION 42.47 • n=206 Participants
|
169.40 mg/dl
STANDARD_DEVIATION 43.78 • n=7 Participants
|
|
HDL-c
|
40.95 mg/dl
STANDARD_DEVIATION 14.37 • n=99 Participants
|
42.50 mg/dl
STANDARD_DEVIATION 12.07 • n=107 Participants
|
42.21 mg/dl
STANDARD_DEVIATION 15.27 • n=206 Participants
|
41.85 mg/dl
STANDARD_DEVIATION 13.92 • n=7 Participants
|
|
LDL-c
|
98.45 mg/dl
STANDARD_DEVIATION 36.61 • n=99 Participants
|
90.00 mg/dl
STANDARD_DEVIATION 37.53 • n=107 Participants
|
103.81 mg/dl
STANDARD_DEVIATION 36.03 • n=206 Participants
|
97.65 mg/dl
STANDARD_DEVIATION 36.79 • n=7 Participants
|
|
Fasting blood glucose level
|
91.91 mg/dl
STANDARD_DEVIATION 13.16 • n=99 Participants
|
97.74 mg/dl
STANDARD_DEVIATION 14.29 • n=107 Participants
|
91.90 mg/dl
STANDARD_DEVIATION 13.93 • n=206 Participants
|
93.85 mg/dl
STANDARD_DEVIATION 13.96 • n=7 Participants
|
|
Transfusions
|
0.66 average number of transfusions/patient
STANDARD_DEVIATION 1.27 • n=99 Participants
|
0.85 average number of transfusions/patient
STANDARD_DEVIATION 2.50 • n=107 Participants
|
0.83 average number of transfusions/patient
STANDARD_DEVIATION 2.12 • n=206 Participants
|
0.78 average number of transfusions/patient
STANDARD_DEVIATION 1.99 • n=7 Participants
|
|
Cold ischemia time
|
16.83 hours
STANDARD_DEVIATION 5.52 • n=99 Participants
|
18.15 hours
STANDARD_DEVIATION 5.40 • n=107 Participants
|
17.26 hours
STANDARD_DEVIATION 6.36 • n=206 Participants
|
17.41 hours
STANDARD_DEVIATION 5.75 • n=7 Participants
|
|
Age of the donor
|
62.11 years
STANDARD_DEVIATION 10.43 • n=99 Participants
|
62.88 years
STANDARD_DEVIATION 8.92 • n=107 Participants
|
61.62 years
STANDARD_DEVIATION 10.02 • n=206 Participants
|
62.20 years
STANDARD_DEVIATION 9.75 • n=7 Participants
|
|
Donor creatinine levels
|
0.80 mg/dl
STANDARD_DEVIATION 0.28 • n=99 Participants
|
0.83 mg/dl
STANDARD_DEVIATION 0.40 • n=107 Participants
|
0.87 mg/dl
STANDARD_DEVIATION 0.29 • n=206 Participants
|
0.83 mg/dl
STANDARD_DEVIATION 0.32 • n=7 Participants
|
|
Human leucocyte antigens (HLA) class I (A, B) and class II (DR) incompatibilities
|
3.55 number of incompatibilities
STANDARD_DEVIATION 1.17 • n=99 Participants
|
4.00 number of incompatibilities
STANDARD_DEVIATION 0.87 • n=107 Participants
|
4.24 number of incompatibilities
STANDARD_DEVIATION 1.10 • n=206 Participants
|
3.93 number of incompatibilities
STANDARD_DEVIATION 1.10 • n=7 Participants
|
|
Anti-HLA lymphocytotoxic antibodies against <25% a reference panel
Yes
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Anti-HLA lymphocytotoxic antibodies against <25% a reference panel
No Antibodies
|
41 participants
n=99 Participants
|
40 participants
n=107 Participants
|
40 participants
n=206 Participants
|
121 participants
n=7 Participants
|
|
Anti-HLA lymphocytotoxic antibodies against <25% a reference panel
Not available
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end
American Diabetes Association criteria (ADA) including an oral glucose tolerance test.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=41 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=38 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT)
% of patients with NODAT
|
34.1 percentage of participants
Interval 21.6 to 49.5
|
23.1 percentage of participants
Interval 12.7 to 38.3
|
7.9 percentage of participants
Interval 2.7 to 20.8
|
|
Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT)
% of patients without NODAT
|
65.9 percentage of participants
Interval 50.5 to 78.4
|
76.9 percentage of participants
Interval 61.6 to 87.3
|
92.1 percentage of participants
Interval 79.2 to 97.3
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participant analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=41 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=38 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Patients Treated With Insulin or Oral Antidiabetic Drugs
|
20 percentage of participants
Interval 10.5 to 34.8
|
15.4 percentage of participants
Interval 7.3 to 29.7
|
2.6 percentage of participants
Interval 0.5 to 13.5
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participants included are those that did not develop NODAT based on not reporting the use of anti-diabetic drugs plus a fasting plasma glucose \<126 mg/dl .
Glycemia \>=140 and \<200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=26 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=29 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=30 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Primary Outcome Measure (Glucose Intolerance)
|
26.9 percentage of participants
Interval 13.7 to 46.1
|
31.0 percentage of participants
Interval 17.3 to 49.2
|
33.3 percentage of participants
Interval 19.2 to 51.2
|
SECONDARY outcome
Timeframe: 1 yearBiopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=44 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=42 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=42 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Rejection
|
11.4 percentage of participants
Interval 4.95 to 24.0
|
4.8 percentage of participants
Interval 1.3 to 15.8
|
21.4 percentage of participants
Interval 11.7 to 36.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: Participants living with a functioning graft at study end.
Estimated Glomerular Filtration Rate (ml/min/1.73 m\^2)
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=41 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=38 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Renal Function
|
51.9 ml/min/1.73 m^2
Interval 45.2 to 58.5
|
47.4 ml/min/1.73 m^2
Interval 42.9 to 52.0
|
44.6 ml/min/1.73 m^2
Interval 37.8 to 51.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=36 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=36 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Proteinuria
|
208 mg/day
Interval 121.0 to 296.0
|
241 mg/day
Interval 110.0 to 373.0
|
343.2 mg/day
Interval 154.0 to 532.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Systolic pressure (mmHg)
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=36 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Blood Pressure
|
135.36 mmHg
Standard Deviation 15.75
|
133.97 mmHg
Standard Deviation 13.67
|
136.28 mmHg
Standard Deviation 17.27
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Diastolic pressure (mmHg)
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=36 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Blood Pressure
|
76.67 mmHg
Standard Deviation 8.93
|
74.59 mmHg
Standard Deviation 9.83
|
76.64 mmHg
Standard Deviation 10.27
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=41 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=38 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Number of Antihypertensive Drugs Patients Reported Taking.
|
2 number of antihypertensive drugs
Interval 1.0 to 3.0
|
2 number of antihypertensive drugs
Interval 1.0 to 2.0
|
2 number of antihypertensive drugs
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=37 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=37 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Lipidic Profile (Triglycerides)
|
159.44 mg/dl
Standard Deviation 93.68
|
145.59 mg/dl
Standard Deviation 52.97
|
160.78 mg/dl
Standard Deviation 84.26
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Lipidic Profile (total cholesterol)
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=37 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=38 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Lipidic Profile (Cholesterol)
|
169.05 mg/dl
Standard Deviation 30.57
|
178.24 mg/dl
Standard Deviation 33.64
|
168.89 mg/dl
Standard Deviation 33.38
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=38 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=35 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=34 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Lipidic Profile (HDL-c)
|
44.84 mg/dl
Standard Deviation 13.89
|
49.29 mg/dl
Standard Deviation 16.90
|
48.35 mg/dl
Standard Deviation 16.59
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=37 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=35 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=34 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Lipidic Profile (LDL-c)
|
94.00 mg/dl
Standard Deviation 27.04
|
95.43 mg/dl
Standard Deviation 26.54
|
88.65 mg/dl
Standard Deviation 25.73
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=41 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=38 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Percentage of Patients Using Statins
|
56. percentage of participants
Interval 41.0 to 70.0
|
61.5 percentage of participants
Interval 45.9 to 75.1
|
73.7 percentage of participants
Interval 58.0 to 85.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants analyzed: participants living with a functioning graft at study end.
absolute difference between carotid intima-media thickness at study end versus baseline.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=9 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=8 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=10 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Changes of Carotid Intima-media Thickness Over Time
|
0.12 mm
Interval 0.09 to 0.15
|
0.04 mm
Interval -0.15 to 0.23
|
0.01 mm
Interval -0.01 to 0.03
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Analysis population description: participants living with a functioning graft at study end.
Outcome measures
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=39 Participants
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=37 Participants
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=36 Participants
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Percentage of Patients Using Acetylsalicylic Acid (ASA)
|
53.9 percentage of participants
Interval 38.6 to 68.4
|
48.7 percentage of participants
Interval 33.5 to 64.1
|
52.8 percentage of participants
Interval 37.0 to 68.0
|
Adverse Events
Tacrolimus With Rapid Steroid Withdrawal
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Tacrolimus With Steroids Minimization
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
CsA With Steroid Minimization
Serious events: 12 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=44 participants at risk
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=42 participants at risk
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=42 participants at risk
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Cardiac disorders
Heart attack resulting in death event
|
2.3%
1/44 • Number of events 1 • 1 year
|
0.00%
0/42 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
|
Cardiac disorders
Shock resulting in death event
|
0.00%
0/44 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
0.00%
0/42 • 1 year
|
|
Immune system disorders
Acute Rejection
|
11.4%
5/44 • Number of events 5 • 1 year
|
4.8%
2/42 • Number of events 2 • 1 year
|
21.4%
9/42 • Number of events 9 • 1 year
|
|
Immune system disorders
Graft Loss
|
2.3%
1/44 • Number of events 1 • 1 year
|
4.8%
2/42 • Number of events 2 • 1 year
|
4.8%
2/42 • Number of events 2 • 1 year
|
|
Infections and infestations
Pneumonia resulting in death event
|
2.3%
1/44 • Number of events 1 • 1 year
|
0.00%
0/42 • 1 year
|
0.00%
0/42 • 1 year
|
|
Infections and infestations
Sepsis resulting in death event
|
0.00%
0/44 • 1 year
|
0.00%
0/42 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Tacrolimus With Rapid Steroid Withdrawal
n=44 participants at risk
Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4).
|
Tacrolimus With Steroids Minimization
n=42 participants at risk
Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4).
|
CsA With Steroid Minimization
n=42 participants at risk
CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4).
|
|---|---|---|---|
|
Cardiac disorders
Acute Miocardial Infarction or Coronary Revascularization
|
0.00%
0/44 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
4.8%
2/42 • Number of events 2 • 1 year
|
|
Vascular disorders
Stroke
|
0.00%
0/44 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
0.00%
0/42 • 1 year
|
|
Infections and infestations
BK Virus Infection
|
9.1%
4/44 • Number of events 4 • 1 year
|
4.8%
2/42 • Number of events 2 • 1 year
|
7.1%
3/42 • Number of events 3 • 1 year
|
|
Infections and infestations
CMV Infection
|
15.9%
7/44 • Number of events 7 • 1 year
|
14.3%
6/42 • Number of events 6 • 1 year
|
28.6%
12/42 • Number of events 12 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/44 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
|
Infections and infestations
Acute Pyelonephritis of the graft
|
4.5%
2/44 • Number of events 2 • 1 year
|
14.3%
6/42 • Number of events 6 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
2.3%
1/44 • Number of events 1 • 1 year
|
11.9%
5/42 • Number of events 5 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasia
|
0.00%
0/44 • 1 year
|
2.4%
1/42 • Number of events 1 • 1 year
|
4.8%
2/42 • Number of events 2 • 1 year
|
Additional Information
Dr. Armando Torres Ramírez
Hospital Universitario de Canarias. Universidad de La Laguna. Spain
Phone: +34630989515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place