Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
This study has been completed.
Information provided by (Responsible Party):
Anthony Langone, Vanderbilt University Medical Center
First received: September 19, 2005
Last updated: February 21, 2017
Last verified: February 2008
A study to determine the effect on renal function in renal transplant patients with biopsy proven CAN nephropathy who are switched from a CI triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
||Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
Primary Outcome Measures:
- Graft Survival [ Time Frame: 3 years ]
20 renal transplant patients who received a renal biopsy for graft dysfunction and were found to have pure CAN (no other pathologic findings on biopsy) were randomized in a 2:1 fashion to convert to rapamycin (goal 24 trough 5ng/ml) or remain on their CNI with low target serum levels (50ng/ml-125ng/ml 12 hr trough). The patients were asked to undergo a second biopsy at the end of their follow up period (minimun 3 years). Patients underwent a DTPA nuclear study to obtain an accurate GFR at study entry and repeated the nuclear study at the end of the study to determine the change in creatinine clearance in an accurate manner. In addition, laboratories were obtained at predetermined intervals.
Univariat analysis resulted in the primary end-point of improved graft survival not being statistically achieved with conversion to Rapamycin. seconday end points of renal function measured directly by dtpa, calculated by MDRD equation and histologic (biopsy) interstitial fibrosis was no
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Active Comparator: 1
pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prgraf). 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
Other Name: Sirolimus
No Intervention: 2
Patient will remain on calcineruin inhibitor
|Ages Eligible for Study:
||12 Years and older (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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.
- 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 Crockcroft/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 > 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00223678
|Nashville, Tennessee, United States, 37232 |
Vanderbilt University Medical Center
||Anthony Langone, M.D.
||Anthony Langone, Anthony Langone M.D., Vanderbilt University Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 19, 2005
|Results First Received:
||February 21, 2017
||February 21, 2017
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 25, 2017
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs