The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

PHASE4CompletedINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

April 30, 2001

Primary Completion Date

November 30, 2007

Study Completion Date

December 31, 2008

Conditions
Kidney Diseases
Interventions
DRUG

Anti-thymocyte globulin

Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)

DRUG

Mycophenolate mofetil

Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance

DRUG

Prednisone

Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92

DRUG

Tacrolimus

Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)

DRUG

Sirolimus

Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

collaborator

Genzyme, a Sanofi Company

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

lead

Mayo Clinic

OTHER

NCT00275535 - The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients | Biotech Hunter | Biotech Hunter