Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00428064

Collaborator

(none)

408

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Sirolimus Drug: cyclosporine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Randomized, Open-Label Study of Continuous Therapy With Cyclosporine and Sirolimus Versus Induction With Cyclosporine and Sirolimus Followed by Continuous Therapy With Sirolimus in Renal Allograft Recipients

Study Start Date :

May 1, 1998

Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Equivalence of graft survival at month 12 []

Secondary Outcome Measures

Renal function; biopsy-confirmed acute rejection, grade of acute rejection; subject and graft survival; incidence of infection, malignancy, treatment failure, and of chronic rejection as determined by protocol biopsies; quality of life. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts 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