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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:
ClinicalTrials.gov Identifier:
NCT00223678
First Posted: September 22, 2005
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthony Langone, Vanderbilt University Medical Center
  Purpose
A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (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: None (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 Anthony Langone, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Graft Survival [ Time Frame: 3 years ]

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, Prograf). 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

Information from the National Library of Medicine

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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 Institutional Review Board (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 Cockcroft/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 > Class 2 (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 19, 2005
First Posted: September 22, 2005
Results First Submitted: February 21, 2017
Results First Posted: April 6, 2017
Last Update Posted: June 21, 2017
Last Verified: May 2017

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