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Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

CompletedPhase 4

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Conditions: Kidney Transplantation

Interventions: Rapamune® (Sirolimus), Neoral® (Cyclosporine), Corticosteroids

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

Eligibility overview

Sex: ALL

Age: 18 Months to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adults more than 18 years of age
* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
* Patients with a secondary transplant must have maintained their primary graft for at least 6 months

Exclusion Criteria:

* Planned antibody induction therapy
* Multiple organ transplants
* Patients at a high risk of acute rejection