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

NCT00223678 | Completed Phase 4 Results

• 1 other identifier: 000294
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Graft Survival

  3 years

Study Arms (2)

1

ACTIVE COMPARATOR

pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin

Drug: Rapamycin

2

NO INTERVENTION

Patient will remain on calcineruin inhibitor

Interventions

Rapamycin DRUG

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

Also known as: Sirolimus

1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is the recipient of a cadaveric or living donor renal transplant.
• Patient was \> 12 years of age at the time of transplant.
• Patient is at least 3 months post-transplant.
• Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
• 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.
• Patients had a renal biopsy that shows chronic allograft nephropathy.
• 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.
• 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.

You may not qualify if:

• Patient is the recipient of a solid organ transplant other than the kidney.
• Patient is dialysis dependent.
• Patient has recurrence of primary renal disease, or de novo renal disease.
• Patient has an estimated creatinine clearance \<25ml/min calculated using the Cockcroft/Gault formula.
• Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
• Baseline biopsy shows acute rejection Banff Grade \> Class 2 (IIB).
• Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy.
• Patient has received an investigational immunosuppressant within three months.
• Patient is pregnant or lactating.
• Patient is a known carrier of any of the HIV viruses.
• Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Anthony Langone
• Organization: Vanderbilt Medical Center

anthony.langone@vanderbilt.edu

615-936-1179

Study Officials

• Anthony Langone, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anthony Langone M.D.

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2000
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 21, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-05

Locations

US (1)