Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplantation
Intervention: Sirolimus (Drug); cyclosporine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth
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.
Clinical Details
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 design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Equivalence of graft survival at month 12
Secondary outcome: 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
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: May 1998
Ending date: June 2004
Last updated: January 26, 2007
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