Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplant
Intervention: Cyclosporine (Drug)
Phase: Phase 1/Phase 2
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.
- 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
- Subjects must be at least 18 years of age.
- Subjects with active major infection, including active hepatitis B or C infection,
HIV, decreased platelets, elevated lipids, or multiple organ transplants.
Locations and Contacts
Starting date: June 2004
Ending date: August 2006
Last updated: June 8, 2007