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

• Status: Completed
• Trial end date: 2001-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus; Tacrolimus

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