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CLIO: Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05136963
Collaborator
(none)
48
Enrollment
1
Location
1
Arm
22
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method [Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration]

      Clearance of Iohexol calculated with Bayesian estimator (limited samples) and with classic method (rich samples).

    Secondary Outcome Measures

    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]

      Clearance of Iohexol calculated with Bayesian estimator (limited samples) and Brochner-Mortensen method (5 samples).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire Saint-Étienne France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Saint Etienne

    Investigators

    • Principal Investigator: Christophe MARIAT, MD PhD, CHU SAINT-ETIENNE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Saint Etienne
    ClinicalTrials.gov Identifier:
    NCT05136963
    Other Study ID Numbers:
    • 19CH047
    • 2020-000853-29
    First Posted:
    Nov 30, 2021
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
    iohexol
    clearance
    glomerular filtration flow rate
    kidney donor

    Study Results

    No Results Posted as of Dec 14, 2021