Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

Wyeth

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518271

0468E1-100193

Details and patient eligibility

About

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids.

Full description

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 donor
• Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

• Planned antibody induction
• Multiple organ transplants
• Patients at high risk of acute rejection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)