Status:
COMPLETED
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Graft Rejection
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograf...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match.
- Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- Other inclusions apply.
Exclusion
- Evidence of active systemic or localized major infection.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
- Other exclusions apply.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00266123
Start Date
March 1 2004
End Date
July 1 2007
Last Update
December 27 2007
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