Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

January 31, 2001

Primary Completion Date

October 31, 2007

Study Completion Date

August 31, 2010

Conditions
Bronchiolitis ObliteransImmunosuppression
Interventions
DRUG

Tacrolimus

Tacrolimus therapy was started immediately after transplantation with a continuous intravenous infusion of 0.01-0.03 mg/kg/d. After extubation, the mode of delivery was switched to oral administration (b.i.d.) with doses of 0.05-0.3 mg/kg/d. Tacrolimus doses were adjusted to trough levels. Target C0 (trough) levels were 10-15 ng/ml for the first 3 months after transplantation and 8-12 ng/ml thereafter with dose adjustments according to patient outcome.

DRUG

Cyclosporine

Cyclosporine therapy was started immediately after transplantation with a continuous intravenous infusion of 1-3 mg/kg/d. After extubation the mode of delivery was switched to oral administration (b.i.d. or t.i.d.) with doses of 4-18 mg/kg/d. Cyclosporine doses were adjusted to C0 or C2 levels according to local practice. Target trough levels were 200 - 300 ng/ml for the first 3 months after transplantation and 150 - 200 ng/ml thereafter.

Trial Locations (14)

1011

Centre hospitalier universitaire vaudois, Lausanne

1070

Hospital Erasme, Brussels

1090

Allgemeines Krankenhaus Wien, Vienna

3000

Universitaire Ziekenhuizen, Leuven

14004

Hospital Reina Sofia, Córdoba

15006

Hospital Juan Canalejo, A Coruña

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

24105

Universitätsklinikum Kiel, Kiel

28035

Clínica Puerta de Hierro, Madrid

39008

Hospital Marques de Valdecilla, Santander

45147

Universitätsklinikum Essen, Essen

NSW 2010

St. Vincent's Hospital, Sydney

07740

Universitätsklinikum Jena, Jena

08035

Hospital Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Universitätsklinikum Hamburg-Eppendorf

OTHER

NCT01429844 - Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation | Biotech Hunter | Biotech Hunter