Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
Phase 3
Completed
- Conditions
- Kidney Disease
- Registration Number
- NCT00248313
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
Inclusion Criteria
- 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).
Exclusion Criteria
- 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®.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Kidney Function at 12 months after transplantation.
- Secondary Outcome Measures
Name Time Method Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.