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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


Phase 3
13 Years
N/A
Not Enrolling
Both
Renal Transplantation

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Equivalence of graft survival at month 12

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

European Union: European Medicines Agency

Study ID:

0468H1-310

NCT ID:

NCT00428064

Start Date:

May 1998

Completion Date:

June 2004

Related Keywords:

  • Renal Transplantation
  • Renal allograft
  • Renal
  • Kidney
  • Transplant

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