Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

December 23, 2020

Primary Completion Date

January 25, 2024

Study Completion Date

October 31, 2026

Conditions
Prophylaxis Against Liver Transplant Rejection
Interventions
DRUG

Tacrolimus Pill

Envarsus® tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml.

DRUG

Tacrolimus capsule

Advagraf® capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml.

Trial Locations (15)

13353

Charite - University Medicine Berlin, Berlin

20246

University Hospital Hamburg Eppendorf, Hamburg

24105

University Hospital Schleswig-Holstein - Campus Kiel, Kiel

30625

Hannover Medical School, Hanover

39120

University Hospital Magdeburg, Magdeburg

45147

University Hospital Essen, Essen

48149

University Hospital Muenster, Münster

52074

University Hospital Aachen, Aachen

55131

University Hospital Mainz, Mainz

60590

University Hospital Frankfurt, Frankfurt

69120

University Hospital Heidelberg, Heidelberg

72076

University Hospital Tuebingen, Tübingen

93053

University Hospital Regensburg, Regensburg

07747

University Hospital Jena, Jena

04103

University Hospital Leipzig, Leipzig

Sponsors
All Listed Sponsors
collaborator

Chiesi Pharmaceuticals GmbH

INDUSTRY

collaborator

Excelya

INDUSTRY

lead

Edward Geissler

OTHER

NCT04720326 - Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients | Biotech Hunter | Biotech Hunter