Overview

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Status:
Completed
Trial end date:
2005-01-01
Target enrollment:
0
Participant gender:
All
Summary
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Everolimus
Immunosuppressive Agents
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Sirolimus
Tacrolimus
Criteria
Inclusion Criteria:

- Age: 18 and < 65 years

- End-stage renal disease, with patients scheduled to receive a primary renal allograft
from a cadaveric donor

- Patients receiving a second transplant without an immunological loss of their first
graft in the first six months of transplant

Exclusion Criteria:

- Evidence of active systemic or localized major infection at the time of initial
sirolimus administration

- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
pre-study screening

- Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the
study and during the 12-month treatment phase