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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000853-29 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iohexol | Drug | 5 milliliter of iohexol will be administrated. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe MARIAT, MD PhD | Contact | (0)477828739 | +33 | christophe.mariat@chu-st-etienne.fr |
| Carine LABRUYERE, CRA | Contact | (0)477120826 | +33 | carine.labruyere@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christophe MARIAT, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D007472 | Iohexol |
| D010599 | Pharmacokinetics |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| 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 |
|
|
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008660 | Metabolism |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |