Graft Rejection, Kidney Failure, Kidney Transplant
Conditions
Keywords
Kidney Failure, Kidney Transplant
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 allograft function at month 12 post-transplantation.
Interventions
DRUGSirolimus
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kidney function at 52 weeks after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Kidney function at 26, 78 and 104 weeks after transplantation | — |
Outcome results
None listed