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

Study Overview

• Status: Completed
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: Rapamycin

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Sirolimus
No Intervention: 2; Patient will remain on calcineruin inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Graft Survival	3 years

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Anthony Langone, M.D., Vanderbilt University

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 000294