Overview

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.