Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Condition(s) targeted: Kidney Transplant

Intervention: Cyclosporine (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth

Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

Official title: A Nonrandomized, Open-Label, Multicenter, Sequential Phase Study to Evaluate the Safety and Efficacy of Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese De Novo Renal Allograft Recipients Receiving Rapamune

Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.

Secondary outcome: To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 12 months post-transplantation.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with end-stage renal disease scheduled to receive a primary renal allograft

from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor.

- Subjects must be at least 18 years of age.

Exclusion Criteria:

- Subjects with active major infection, including active hepatitis B or C infection,

HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Starting date: June 2004
Ending date: August 2006
Last updated: June 8, 2007