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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2008 by Vanderbilt University.
Recruitment status was:  Active, not recruiting
Information provided by:
Vanderbilt University Identifier:
First received: September 19, 2005
Last updated: February 21, 2008
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

Condition Intervention Phase
Kidney Transplant
Drug: Rapamycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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:

Primary Outcome Measures:
  • graft survival [ Time Frame: 3 years ]

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
Active Comparator: 1
pt will switch from calcineurin inhibitor (CYA, prgraf) 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


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00223678

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

Responsible Party: Dr Anthony Langone, Vanderbilt University Identifier: NCT00223678     History of Changes
Other Study ID Numbers: 000294
Study First Received: September 19, 2005
Last Updated: February 21, 2008

Additional relevant MeSH terms:
Calcineurin Inhibitors
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents processed this record on March 29, 2017