Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Wyeth

Status and phase

Completed

Phase 4

Conditions

Kidney Failure

Kidney Transplantation

Graft Rejection

Treatments

Drug: sirolimus

Drug: tacrolimus

Drug: mycophenolate mofetil

Drug: methylprednisolone

Drug: prednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261820

0468E1-100194

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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