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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: May 24, 2017
Last verified: May 2017
September 19, 2005
May 24, 2017
June 2000
October 2009   (Final data collection date for primary outcome measure)
Graft Survival [ Time Frame: 3 years ]
Not Provided
Complete list of historical versions of study NCT00223678 on ClinicalTrials.gov Archive Site
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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
Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Kidney Transplant
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
  • Active Comparator: 1
    pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
    Intervention: Drug: Rapamycin
  • No Intervention: 2
    Patient will remain on calcineruin inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2009
October 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00223678
000294
No
Not Provided
Not Provided
Anthony Langone, Vanderbilt University Medical Center
Vanderbilt University Medical Center
Not Provided
Principal Investigator: Anthony Langone, M.D. Vanderbilt University
Vanderbilt University Medical Center
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP