Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

Phase 1Not Yet RecruitingNCT05136963

Centre Hospitalier Universitaire de Saint Etienne48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Kidney Function Test

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration

Secondary Outcomes

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).