Overview

Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
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 allograft function at month 12 post-transplantation.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.