Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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 Start Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.
Secondary Outcome Measures :
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Subjects with active major infection, including active hepatitis B or C infection, HIV, decreased platelets, elevated lipids, or multiple organ transplants.