Kidney Transplant
Conditions
Brief summary
A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol
Interventions
DRUGRapamycin
Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is the recipient of a cadaveric or living donor renal transplant. 2. Patient was \> 12 years of age at the time of transplant. 3. Patient is at least 3 months post-transplant. 4. Patient has been on a calcineurin inhibitor based immunosuppression since the transplant. 5. Patient has one of the following risk factors for chronic renal allograft failure: I. Serum creatinine \> 2.0 mg/dL 3 months or later post-transplant in males patients. II. Serum creatinine \> 1.7 mg/dL 3 months or later post-transplant in female patients. III. Serum \> 30% increased over post discharge nadir. 6. Patients had a renal biopsy that shows chronic allograft nephropathy. 7. Patient or legal guardian had signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures. 8. If female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF), Rapamycin and other immunosuppressants. \-
Exclusion criteria
1. Patient is the recipient of a solid organ transplant other than the kidney. 2. Patient is dialysis dependent. 3. Patient has recurrence of primary renal disease, or de novo renal disease. 4. Patient has an estimated creatinine clearance \<25ml/min calculated using the Cockcroft/Gault formula. 5. Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization. 6. Baseline biopsy shows acute rejection Banff Grade \> Class 2 (IIB). 7. Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy. 8. Patient has received an investigational immunosuppressant within three months. 9. Patient is pregnant or lactating. 10. Patient is a known carrier of any of the HIV viruses. 11. Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft Survival | 3 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rapamycin pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15 | 13 |
| CYA/Prograf Patient will remain on calcineurin inhibitor,CYA/Prograf | 7 |
| Total | 20 |
Baseline characteristics
| Characteristic | Rapamycin | CYA/Prograf | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 7 Participants | 20 Participants |
| Region of Enrollment United States | 13 participants | 7 participants | 20 participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 7 |
| serious Total, serious adverse events | 9 / 13 | 2 / 7 |
Outcome results
Primary
Graft Survival
Time frame: 3 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rapamycin Group | Graft Survival | 13 participants |
| CNI Group | Graft Survival | 7 participants |
p-value: 0.849Log Rank