Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

NCT05136963 | Not Yet Recruiting Phase 1

• 2 other identifiers: 19CH0472020-000853-29
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Function Test

Keywords

iohexol; clearance; glomerular filtration flow rate; kidney donor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Iohexol pharmacokinetic calculated with Bayesian estimator and Brochner-Mortensen method

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

Study Arms (1)

volunteers

EXPERIMENTAL

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; Biological: pharmacokinetics

Interventions

Iohexol DRUG

5 milliliter of iohexol will be administrated.

Also known as: Omnipaque

volunteers

pharmacokinetics 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

Also known as: blood sample

volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Volunteers with a history or morbidities that would contraindicate assessment for kidney donation according to current recommendations
• Volunteers having hypersensitivity to Iohexol or one of its excipients
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire

Saint-Etienne, France

Location

MeSH Terms

Interventions

Iohexol; Pharmacokinetics; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Christophe MARIAT, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe MARIAT, MD PhD

CONTACT

(0)477828739; christophe.mariat@chu-st-etienne.fr

Carine LABRUYERE, CRA

CONTACT

(0)477120826; carine.labruyere@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)