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Sponsored by: |
Vanderbilt University |
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00223678 |
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
Condition | Intervention | Phase |
Kidney Transplant |
Drug: Rapamycin |
Phase IV |
MedlinePlus related topics: | Kidney Transplantation |
ChemIDplus related topics: | Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Sirolimus |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure |
Estimated Enrollment: | 30 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
pt will switch from calcineurin inhibitor (CYA, prgraf) to Rapamycin
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Drug: 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
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2: No Intervention
Patient will remain on calcineruin inhibitor
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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.
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 Criteria:
United States, Tennessee | |||||
Vanderbilt University | |||||
Nashville, Tennessee, United States, 37232 |
Vanderbilt University |
Principal Investigator: | Anthony Langone, M.D. | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Dr Anthony Langone ) |
Study ID Numbers: | 000294 |
First Received: | September 19, 2005 |
Last Updated: | February 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00223678 |
Health Authority: | United States: Food and Drug Administration |
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