Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs

PHASE4RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 9, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

September 30, 2029

Conditions
Immunosuppression
Interventions
DRUG

Tacrolimus Pill

Envarsus tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a therapeutic range of 5-12 ng/ml during the first 4 weeks post-transplantation, and 5-8 ng/ml thereafter.

DRUG

Tacrolimus capsule

Advagraf capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a therapeutic range of 5-12 ng/ml during the first 4 weeks post-transplantation, and 5-8 ng/ml thereafter.

Trial Locations (9)

10117

NOT_YET_RECRUITING

Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care, Berlin

20251

RECRUITING

University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology), Hamburg

30625

RECRUITING

Hannover Medical School, Department of General, Visceral and Transplant Surgery, Hanover

48149

NOT_YET_RECRUITING

University Hospital Münster, Medical Clinic D, Münster

52074

NOT_YET_RECRUITING

University Hospital Aachen, Department of General, Visceral and Transplant Surgery, Aachen

55131

NOT_YET_RECRUITING

University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology), Mainz

93053

RECRUITING

University Hospital Regensburg, Department of Nephrology, Regensburg

01307

RECRUITING

University Hospital Dresden, Division of Nephrology, Dresden

07747

RECRUITING

University Hospital Jena, Internal Medicine III, Nephrology, Jena

Sponsors
All Listed Sponsors
collaborator

Chiesi Pharmaceuticals GmbH

INDUSTRY

lead

Edward Geissler

OTHER

NCT06268769 - Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs | Biotech Hunter | Biotech Hunter