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RECRUITING

NCT06268769

PHASE4

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

Sponsor: Edward Geissler

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-03-09

Completion Date

2029-09

Last Updated

2024-05-16

Healthy Volunteers

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.

Inclusion Criteria: 1. Signed and dated written informed consent 2. Adult (≥18 years old) male or female 3. Renal insufficiency necessitating kidney transplantation and approved to receive a first or second kidney allograft from a living or deceased organ donor 4. ABO blood type compatible with the donor kidney 5. Able to swallow an oral formulation of tacrolimus in tablet or capsule form Exclusion Criteria: 1. Multi-organ transplantation 2. Any previous solid organ transplantation (other than a first kidney allograft) 3. For recipients of a second kidney transplant: loss of first kidney transplant within 2 years after transplantation owing to immunological reasons or recurrence of the underlying renal disease 4. Patient and/or donor is positive for HCV, HBV or HIV 5. History of any malignancy that could not be curatively treated 6. Ongoing abuse of drugs or alcohol 7. Signs of advanced liver disease or any signs of liver decompensation 8. Ongoing uncontrolled systemic infection 9. Severe diarrhoea, vomiting, active peptic ulcer, previous bariatric surgery, or any other gastrointestinal disorder that may affect absorption of tacrolimus 10. Planned or foreseeable use of cyclosporine, belatacept or any tacrolimus preparation other than Envarsus® or Advagraf™ 11. Known contraindication or hypersensitivity to tacrolimus, and/or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC) of both Envarsus® and Advagraf™, and/or to any other macrolides 12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test 13. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless using a highly-effective method of contraception 14. Participation in another interventional clinical trial in the time period starting from 4 weeks prior to randomisation and throughout the entire trial period 15. Any condition or factor which, in the judgement of the investigator, would place the subject at undue risk, invalidate communication with the investigator or study team, or hamper compliance with the trial protocol or follow-up schedule 16. Inability to freely give informed consent (e.g. individuals under legal guardianship)

Locations (9)

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

Aachen, Germany

Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care

Berlin, Germany

University Hospital Dresden, Division of Nephrology

Dresden, Germany

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

Hamburg, Germany

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

Hanover, Germany

University Hospital Jena, Internal Medicine III, Nephrology

Jena, Germany

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

Mainz, Germany

University Hospital Münster, Medical Clinic D

Münster, Germany

University Hospital Regensburg, Department of Nephrology

Regensburg, Germany