Overview

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

Status:
Completed

Trial end date:
2006-08-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Treatments:

Cyclosporine
Cyclosporins

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.