Calcineurin Free Immunosuppression in Renal Transplant Recipients

PHASE4CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

January 31, 2001

Primary Completion Date

July 31, 2005

Study Completion Date

July 31, 2005

Conditions
Kidney TransplantationChronic Kidney Disease
Interventions
DRUG

Sirolimus

Loading dose 30 mg for three days, trough level of 10-20 ng/ml month 1-3, 8-15 ng/ml month 4 - 6

DRUG

Cyclosporine A

Loading dose of 300 mg for three days, trough levels 250-300 ng/ml months 1-3, 150-250 ng/ml months 4 to 6

DRUG

Prednisone

0.5 mg/kg, tapering every two weeks until 0.1 mg/kg

DRUG

Mycophenolate mofetil

2 x 1000mg, through level above 2ug/ml

PROCEDURE

Protocol biopsies

protocol kidney biopsies at month one and three

Trial Locations (1)

4031

University Hospital Basel, Clinic for Transplantation Immunology and Nephrology, Basel

All Listed Sponsors
collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

University Hospital, Basel, Switzerland

OTHER

NCT00812123 - Calcineurin Free Immunosuppression in Renal Transplant Recipients | Biotech Hunter | Biotech Hunter