A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

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

Details

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

Criteria

Inclusion Criteria:

• End-stage renal disease, with patients scheduled to receive a kidney transplant.

• Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;

• Signed informed consent.

Exclusion Criteria:

• Evidence of active systemic or localized major infection at the time of initial study drug administration;

• Multiple organ transplants;

• Any pathology or medical condition that can interfere with this protocol study proposal.

Other exclusion applies.