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Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

NCT00519116

CompletedPhase 4

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Conditions: Kidney Transplantation

Interventions: Rapamune® (Sirolimus), Tacrolimus, Perioperative Corticosteroids

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

* At least 18 years of age
* End-stage renal disease in 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 a primary graft for at least 6 months

Exclusion criteria:

* Planned antibody induction
* Multiple organ transplants
* History of malignancy within five years of enrollment