Improved Induction and Maintenance Immunosuppression in Kidney Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

April 1, 2004

Primary Completion Date

April 1, 2011

Study Completion Date

June 1, 2011

Conditions
End-stage Renal Disease
Interventions
DRUG

rabbit anti-thymocyte globulin - single dose

A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.

DRUG

mycophenolate mofetil

Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.

DRUG

rabbit anti-thymocyte globulin - 4 doses

6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.

DRUG

sirolimus

Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection

DRUG

tacrolimus

Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.

Trial Locations (1)

68198

Unversity of Nebraska Medical Center, Omaha

All Listed Sponsors
collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

University of Nebraska

OTHER

NCT00556933 - Improved Induction and Maintenance Immunosuppression in Kidney Transplantation | Biotech Hunter | Biotech Hunter