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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
EU CTIS ID: 2023-503531-18-00
What this study is testing
To compare the relative bioavailability of two once-daily oral formulations of tacrolimus in kidney transplant recipients and show superiority of Envarsus® versus Advagraf™ in terms of C/D (concentration/dose) ratio measured at 12 weeks after organ transplantation. The parameter C/D ratio is used as an estimate of tacrolimus bioavailability.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 active HCV, HBV or HIV infection
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.