Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

Phase 4

Completed

• Conditions: Kidney Transplant
• Interventions: Drug: Rapamycin

• Registration Number: NCT00223678
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-22
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2017-02-21
• Results First Submitted QC: 2017-02-21
• Results First Posted: 2017-04-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rapamycin	pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin

Primary Outcome Measures

Name	Time	Method
Graft Survival	3 years

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States