BridgeMD
Tests treatment safety and results for Kidney Disease, Chronic
Official title Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus
ClinicalTrials.gov ID: NCT06701825
What this study is testing
What is Tacrolimus?
Tacrolimus is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kidney disease, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
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...
- people 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...
- 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.
Where it's taking place
- Madrid, Madrid, Spain
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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.