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

NCT00195429

CompletedPhase 4

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Conditions: Kidney Failure, Graft vs Host Disease

Interventions: Tacrolimus, Sirolimus, prednisone

Countries: Brazil

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.

Eligibility overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

São Paulo, Brazil