MedTrace Logo

Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

NCT00452361 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-09-03

Study results available
· View outcomes & findings →

Summary

This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic allograft nephropathy (CAN).

Conditions

  • Kidney Transplantation

Interventions

DRUG

Sirolimus+MMF or MPS or AZA+Steroid

Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.

DRUG

Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid

The maintenance dose of: 1. MMF will not exceed 1500 mg/day or PMS will not exceed 1080 mg/day 2. AZA will not exceed 75 mg/day Thereafter, at the discretion of the investigator, MMF/MPS or AZA may be: 1. continued for the entire 104-week period of randomized therapy 2. subsequently discontinued 3. restarted after discontinuation

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Taiwan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00452361 on ClinicalTrials.gov