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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Kidney Function Test
• Intervention / Treatment: Drug: Iohexol; Biological: pharmacokinetics

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Christophe MARIAT, MD PhD; Phone Number: +33 (0)477828739; Email: christophe.mariat@chu-st-etienne.fr
• Study Contact Backup: Name: Carine LABRUYERE, CRA; Phone Number: +33 (0)477120826; Email: carine.labruyere@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France
    • Centre Hospitalier Universitaire
    • Sub-Investigator: Patrick MISMETTI, MD PhD
    • Sub-Investigator: Laurent BERTOLETTI, MD PHD
    • Sub-Investigator: Nathalie MOULIN, MD
    • Principal Investigator: Christophe MARIAT, MD PhD
    • Sub-Investigator: Sandrine ACCASSAT, MD
    • Sub-Investigator: Cécile DUVILLARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: Iohexol; 5 milliliter of iohexol will be administrated.; Other Names: Omnipaque; Biological: 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; Other Names: blood sample

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Christophe Mariat, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: clearance; kidney donor; iohexol; glomerular filtration flow rate
• Other Study ID Numbers: 19CH047; 2020-000853-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No