Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
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.
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.
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.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age: = to ≥ 18 years.
End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).
Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.