Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance (NCT05136963) | Clinical Trial Compass
UnknownPhase 1
Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance
France48 participantsStarted 2024-06
Plain-language summary
In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.
Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Affiliated or entitled to a social security scheme
* Volunteers who has received informed information about the study and has co-signed, with the investigator, a consent to participate in the study.
* Aged \> 18 years
Exclusion Criteria:
* Volunteers with a history or morbidities that would contraindicate assessment for kidney donation according to current recommendations
* Participation in another clinical research protocol within 3 months prior to inclusion
* Volunteers having hypersensitivity to Iohexol or one of its excipients
* Administration of iodinated contrast media in the week prior to inclusion
* Known history of an immediate allergic reaction or delayed skin reaction to an iodinated contrast material or any serious doubt about such a history.
* Pregnancy or breastfeeding in progress
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method