Clinical trial NCT05136963: Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance
Official title: Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Kidney Function Test
Keywords: iohexol
clearance
glomerular filtration flow rate
kidney donor
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method
timeFrame: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration
Secondary outcomes:
measure: Iohexol pharmacokinetic calculated with Bayesian estimator and Brochner-Mortensen method
timeFrame: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Christophe MARIAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: