Status:
COMPLETED
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Kidney Failure
Graft vs Host Disease
Eligibility:
All Genders
13+ years
Phase:
PHASE4
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00195429
Start Date
August 1 2005
End Date
October 1 2007
Last Update
December 11 2023
Active Locations (1)
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1
São Paulo, Brazil