PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 28, 2020

Primary Completion Date

November 7, 2023

Study Completion Date

November 7, 2023

Conditions
Kidney TransplantationPancreas TransplantationDiabetes
Interventions
DRUG

Tacrolimus and Tacrolimus Extended Release Oral Tablet [Envarsus]

"Phase 1: standard dose and frequency tacrolimus, used in accordance with licensing and local protocols. Suitable target trough level should be between 7-14 ng/ml.~Phase 2: ENVARSUS® (LCP Tacro - extended release tacrolimus), used once-daily at an initial dose of 0.17mg/kg, dose adjusted to maintain an appropriate therapeutic blood concentration (measured by trough level). Suitable target trough level should be between 7-14 ng/ml."

Trial Locations (1)

44093

Nantes University Hospital, Nantes

All Listed Sponsors
collaborator

Chiesi Farmaceutici S.p.A.

INDUSTRY

lead

Nantes University Hospital

OTHER

NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus | Biotech Hunter | Biotech Hunter