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NCT05136963 | Not yet recruiting | Kidney Function Test

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

Saint Etienne University Hospital Center

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

Kidney Function Test

Intervention/treatment

Iohexol

pharmacokinetics

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 48 participants
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.
Actual Study Start Date : June 2024
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025
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

Biological: pharmacokinetics
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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
Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

Location Details

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Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance

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Locations

Not yet recruiting

France,

University Hospital Center

Saint Etienne, France,