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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Perioperative Corticosteroids; Drug: Tacrolimus; Drug: Rapamune® (Sirolimus)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519116

0468E1-100539

Details and patient eligibility

About

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.

Full description

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. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)