Clinical trial NCT00223678: Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
Official title: Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Graft Survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Anthony Langone, M.D.
role: PRINCIPAL_INVESTIGATOR
References: