NCT00452361

Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipient

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan. The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the CI therapy group (continued CI therapy: group B). Dosage and Administration SRL Therapy: At the time of randomization on day 1, each patient will have been receiving: * triple therapy with a CI (tacrolimus or CsA) that began at the time of transplantation or within 2 weeks thereafter AND * corticosteroids corresponding to a dosage range of 2.5 to 15 mg/day for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent for at least 12 weeks before randomization, PLUS * either MMF (minimum dose 500 mg/day)/MPS (minimum dose 360 mg/day) or AZA (minimum dose 50 mg/day) for at least 12 weeks before randomization. SRL will be added to the immunosuppressive regimen for Group A. Group B will continue on this CI immunosuppressive regimen.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-03-27
• Last updated: 2012-09-03
• Results posted: 2012-09-03

Locations

1 site across 1 country: Taiwan