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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.
Sponsor:
Information provided by (Responsible Party):
Anthony Langone, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00223678
First received: September 19, 2005
Last updated: February 21, 2017
Last verified: February 2008
  Purpose
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

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



Enrollment: 20
Study Start Date: June 2000
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
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
Other Name: Sirolimus
No Intervention: 2
Patient will remain on calcineruin inhibitor

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 Crockcroft/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 > 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00223678

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Anthony Langone, M.D. Vanderbilt University
  More Information

Responsible Party: Anthony Langone, Anthony Langone M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00223678     History of Changes
Other Study ID Numbers: 000294
Study First Received: September 19, 2005
Results First Received: February 21, 2017
Last Updated: February 21, 2017

Additional relevant MeSH terms:
Mycophenolic Acid
Sirolimus
Mycophenolate mofetil
Everolimus
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on May 22, 2017