BridgeMD
Clinical trial to evaluate effectiveness and cost-effectiveness of pre-emptive genotyping strategy to optimise tacrolimus dosage in a pretransplant chronic kidney disease patients
EU CTIS ID: 2024-516596-32-00
What this study is testing
To assess the effectiveness of a pre-emptive pharmacogenetic strategy in reaching tacrolimus target plasma concentrations.
- 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
- Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.
- Subject or their legally authorized representative has voluntarily signed the informed consent document.
- Participant is on the waiting list for a kidney transplant.
- Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.
- Subjects must be naïve to any genotyping test of the following genes: CYP3A5.
You likely can't join if
- Known hypersensitivity/allergy reaction to tacrolimus or any of the excipients.
- History of renal, heart, and/or liver transplant.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.
- Any condition or situation precluding or interfering the compliance with the protocol.
- Any condition at medical discretion for which renal transplantation and/or study treatment should not be received.
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, 18-64 years, 65+ years, 0-17 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.