Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.

Conditions
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Kidney Function Test

Intervention / Treatment
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* Drug: Iohexol
* Biological: pharmacokinetics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteers<br>48 volunteers will be included according to the following demographic characteristics (corresponding to the demographic profile of kidney donors according to the national data of the Biomedicine Agency): aged between 20 and 35 years old: 4 women, 3 men aged between 35 and 50 years old: 7 women, 5 men aged between 50 and 65: 11 women, 8 men > 65 years old: 6 women, 4 men | Drug: Iohexol<br>* 5 milliliter of iohexol will be administrated.<br>* Other names: Omnipaque;Biological: pharmacokinetics<br>* 10 blood samples of 5 milliliter will be performed. sampling time ater administration of Iohexol: 00h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00 and 12h00<br>* Other names: blood sample;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method | Clearance of Iohexol calculated with Bayesian estimator (limited samples) and with classic method (rich samples). | Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iohexol pharmacokinetic calculated with Bayesian estimator and Brochner-Mortensen method | Clearance of Iohexol calculated with Bayesian estimator (limited samples) and Brochner-Mortensen method (5 samples). | Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iohexol, clearance, glomerular filtration flow rate, kidney donor