Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Calcineurin Inhibitors; Cyclosporine; Cyclosporins; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Age greater than or equal to 13 years.

• Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter

• Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

• Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment

• Patients in whom kidney-pancreas or other multiple organ transplants have been performed