Kidney Function TestPhase 1CLIONCT05136963
Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance
A Phase 1 study testing Iohexol and pharmacokinetics in people with Kidney Function Test, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Function Test
- What is being tested?
- Iohexol and pharmacokinetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2024to Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire
Saint-Etienne
Christophe MARIAT, MD PhD
Patrick MISMETTI, MD PhD
About this study
Official title: 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.
- Conditions
- Kidney Function Test
- Being tested
- Iohexol, pharmacokinetics
- Keywords
- iohexol, clearance, glomerular filtration flow rate, kidney donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IohexolDrug
Also called Omnipaque
5 milliliter of iohexol will be administrated.
pharmacokineticsBiological
Also called blood sample
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Iohexol; Biological: pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Clearance of Iohexol calculated with Bayesian estimator (limited samples) and Brochner-Mortensen method (5 samples).
Measured: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study startJun 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MARIAT, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136963
- Sponsor's protocol ID
- 19CH047
- Other IDs
- 2020-000853-29
- Acronym
- CLIO
- Status last verified
- Apr 2024
- First submitted
- 16 Nov 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.
- ClinicalTrials.gov ID
- NCT05136963
- Acronym / sponsor ID
- CLIO / 19CH047
- Conditions
- Kidney Function Test
- Keywords
- iohexol, clearance, glomerular filtration flow rate, kidney donor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| volunteers | Experimental | Drug: Iohexol, Biological: pharmacokinetics48 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IohexolAlso: Omnipaque5 milliliter of iohexol will be administrated. | Drug | volunteers |
| pharmacokineticsAlso: blood sample10 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 | Biological | volunteers |
Primary outcome
Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method
Time frame: 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).
1 secondary outcome
Iohexol pharmacokinetic calculated with Bayesian estimator and Brochner-Mortensen method
Time frame: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe MARIAT, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iohexol and pharmacokinetics in people with Kidney Function Test, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe MARIAT, MD PhD ((0)477828739 ext. +33, christophe.mariat@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iohexol pharmacokinetic calculated with Bayesian estimator and with classic method (time frame: Hours: 0h30, 1h00, 1h30, 02h00, 03h00, 04h00, 05h00, 06h00, 09h00, 12h00 after Iohexol administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.