Multicentre, Open-label, Randomised, Two-arm, Parallel-group, Superiority Trial to Assess Bioavailability and Practicability of Two Once-daily Tacrolimus Formulations, Envarsus® Compared With Advagraf™, Administered in Kidney Transplant Recipients
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed and dated written informed consent
• Adult (≥18 years old) male or female
• Renal insufficiency necessitating kidney transplantation and approved to receive a first or second kidney allograft from a living or deceased organ donor
• ABO blood type compatible with the donor kidney
• Able to swallow an oral formulation of tacrolimus in tablet or capsule form
Locations
Other Locations
Germany
University Hospital Aachen, Department of General, Visceral and Transplant Surgery
NOT_YET_RECRUITING
Aachen
Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care
NOT_YET_RECRUITING
Berlin
University Hospital Dresden, Division of Nephrology
RECRUITING
Dresden
University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology)
RECRUITING
Hamburg
Hannover Medical School, Department of General, Visceral and Transplant Surgery
RECRUITING
Hanover
University Hospital Jena, Internal Medicine III, Nephrology
RECRUITING
Jena
University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology)
NOT_YET_RECRUITING
Mainz
University Hospital Münster, Medical Clinic D
NOT_YET_RECRUITING
Münster
University Hospital Regensburg, Department of Nephrology
RECRUITING
Regensburg
Contact Information
Primary
Edward K. Geissler, PhD
edward.geissler@ukr.de
+49 941 944
Time Frame
Start Date:2024-03-09
Estimated Completion Date:2029-09
Participants
Target number of participants:300
Treatments
Experimental: Envarsus
Participants take prolonged-release tacrolimus tablets (Envarsus) orally once daily and additionally receive standard-of-care immunosuppressive background therapy according to routine practice.
Active_comparator: Advagraf
Participants take prolonged-release tacrolimus capsules (Advagraf) orally once daily and additionally receive standard-of-care immunosuppressive background therapy according to routine practice.