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

Phase 1

Recruiting

• Conditions: Prophylaxis of transplant rejection in adult kidney allograft recipients; MedDRA version: 21.1Level: LLTClassification code: 10050436Term: Prophylaxis against renal transplant rejection Class: 10042613; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

• Registration Number: CTIS2023-503531-18-00
• Lead Sponsor: niversitaetsklinikum Regensburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-25
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

Multi-organ transplantation, Planned or foreseeable use of cyclosporine, belatacept or any tacrolimus preparation other than Envarsus® or Advagraf™, 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, 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, Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless using a highly-effective method of contraception, Participation in another interventional clinical trial in the time period starting from 4 weeks prior to randomisation and throughout the entire trial period, 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, Inability to freely give informed consent (e.g. individuals under legal guardianship), Any previous solid organ transplantation (other than a first kidney allograft), 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, Patient and/or donor is positive for HCV, HBV or HIV, History of any malignancy that could not be curatively treated, Ongoing abuse of drugs or alcohol, Signs of advanced liver disease or any signs of liver decompensation, Ongoing uncontrolled systemic infection, Severe diarrhoea, vomiting, active peptic ulcer, previous bariatric surgery, or any other gastrointestinal disorder that may affect absorption of tacrolimus

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified