Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance (CLIO)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Not yet enrolling; Phase 1

Conditions: Kidney Function Test

Treatments: Biological: pharmacokinetics; Drug: Iohexol

Study type: Interventional

Funder types: Other

Identifiers

NCT05136963

2020-000853-29 (EudraCT Number)

19CH047

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

volunteers

Experimental group

Description:

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

Treatment:

Drug: Iohexol

Biological: pharmacokinetics