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

Kidney Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00223678
• Other study ID #: 000294
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 19, 2005
• Last updated: February 21, 2008
• Start date: June 2000
• Est. completion date: December 2008

Study information

• Verified date: February 2008
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft survival		3 years	Yes