Study Evaluating Sirolimus in Kidney Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

July 31, 2008

Study Completion Date

July 31, 2008

Conditions
Graft vs Host DiseaseKidney Transplantation
Interventions
DRUG

sirolimus

15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12

DRUG

cyclosporine

Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12

DRUG

mycophenolate mofetil

1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events

DRUG

corticosteroids

As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day

DRUG

daclizumab

IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation

Trial Locations (3)

N-0027

Oslo

SE-413 45

Gothenburg

SE-751 85

Uppsala

All Listed Sponsors
lead

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

NCT00195273 - Study Evaluating Sirolimus in Kidney Transplant Recipients | Biotech Hunter | Biotech Hunter