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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 because the information has not been verified recently.
Verified February 2008 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00223678
First received: September 19, 2005
Last updated: February 21, 2008
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • graft survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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
Investigators
Principal Investigator: Anthony Langone, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Dr Anthony Langone, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00223678     History of Changes
Other Study ID Numbers: 000294
Study First Received: September 19, 2005
Last Updated: February 21, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013