Status:
COMPLETED
Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Kidney Transplant
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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) trip...
Eligibility Criteria
Inclusion
- Patient is the recipient of a cadaveric or living donor renal transplant.
- Patient was \> 12 years of age at the time of transplant.
- Patient is at least 3 months post-transplant.
- Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
- 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.
- Patients had a renal biopsy that shows chronic allograft nephropathy.
- 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.
- 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.
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Exclusion
- Patient is the recipient of a solid organ transplant other than the kidney.
- Patient is dialysis dependent.
- Patient has recurrence of primary renal disease, or de novo renal disease.
- Patient has an estimated creatinine clearance \<25ml/min calculated using the Cockcroft/Gault formula.
- Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
- Baseline biopsy shows acute rejection Banff Grade \> Class 2 (IIB).
- Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy.
- Patient has received an investigational immunosuppressant within three months.
- Patient is pregnant or lactating.
- Patient is a known carrier of any of the HIV viruses.
- Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00223678
Start Date
June 1 2000
End Date
October 1 2009
Last Update
June 21 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232