Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-04-30

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.

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Detailed Description

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Conditions

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Kidney Function Test

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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volunteers

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

Group Type EXPERIMENTAL

Iohexol

Intervention Type DRUG

5 milliliter of iohexol will be administrated.

pharmacokinetics

Intervention Type BIOLOGICAL

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

Interventions

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Iohexol

5 milliliter of iohexol will be administrated.

Intervention Type DRUG

pharmacokinetics

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Omnipaque blood sample

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes