Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

Wyeth

Status and phase

Completed

Phase 3

Conditions

Renal Transplantation

Treatments

Drug: cyclosporine

Drug: Sirolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00428064

0468H1-310

Details and patient eligibility

About

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.

Sex

All

Ages

13+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus

Exclusion criteria

Evidence of active systemic or localized major infection at the time of initial sirolimus administration
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery