Acute Renal FailurePhase 3IOXSORNCT02961478
Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
A Phase 3 study testing IOHEXOL in people with Acute Renal Failure, run by University Hospital, Angers at 11 sites in France.
Trial summary
IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- IOHEXOL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesFrance
- Study dates
- 10 Feb 2017to 11 Nov 2022
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU stay > 7 days
- Having presented during the stay renal failure stage 2 or 3 Kidney Disease Improving Global Outcomes (KDIGO)
- Steady improvement of renal function before the ICU discharge :
- Creatinine before ICU discharge <110 µmol / L for women, <130 µmol / L for men
- No recourse to extra renal purification
- Change in creatinine levels (ΔCréatinine) less than 20% over two measures spaced 24 hours within 48 hours preceding the discharge
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- Expected discharge ICU within 48 hours :
- Glasgow score > 13
- Lack of mechanical ventilation except home Noninvasive Mechanical Ventilation (NiMV)
- Lack of use of catecholamine
- No contra-indication for discharge according to physician in charge of the patient
- Informed consent signed by the patient, where not possible by the person of trust or the family if present. Written consent by the patient will be obtained as soon as deemed possible.
Who cannot join
- Iohexol administration within 48 hours preceding the potential inclusion (imaging examination with X-ray contrast medium injection)
- Iohexol administration planned within 24 hours after potential inclusion in the study
- Known medical history of immediate allergic or delayed skin allergic reaction to injection of iodinated contrast material or any serious doubt on this medical history
- Patient receiving from extra renal purification during ICU discharge
- Chronic renal disease known (creatinine> 110 µmol / L for women,> 130 µmol / L for men) or creatinine clearance estimated less than 60 mL / min
- Pregnancy or breastfeeding women
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- Patient under guardianship or safeguard justice known at the time of inclusion
- Patient limitation care
- Person not affiliated or not the beneficiary of a social security scheme
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
University Hospital
Angers
University Hospital of Brest
Brest
Hospital center
Chartres
Jean Perrin Center
Clermont-Ferrand
Vendée Department Hospital Center
La Roche-sur-Yon
Hospital
Le Mans
University Hospital of Nantes
Nantes
University Hospital of NIce
Nice
Saint-Louis Hospital APHP
Paris
University Hospital
Poitiers
University Hospital
Tours
About this study
IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.
- Conditions
- Acute Renal Failure
- Being tested
- IOHEXOL
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOHEXOLDrug
Also called Omnipaque ®
Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure.
| Study group | Role | What they receive |
|---|---|---|
| Iohexol plasmatic clearance | Experimental | Not described Receives: Drug: IOHEXOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.
Iohexol clearance pharmacokinetics
Measured: 24 hours
Secondary outcomes (3)
Correlation between non resolutive renal at the end of ICU (iohexol clearance < 60 ml/min/1m273) and creatinine clearance < 60 ml/min/1m273 at 6 month after ICU. discharge
Measured: Six month after ICU discharge
Number of risk factors associated with non resolutive among : Age Previous renal function Comorbidities Severity parameters of renal aggression Acute severity of parameters during the ICU hospitalisation
Measured: 24 hours
Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start10 Feb 2017
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- François BELONCLE, CCU-AH, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961478
- Sponsor's protocol ID
- PHRC2015-06
- Acronym
- IOXSOR
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2016
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
- ClinicalTrials.gov ID
- NCT02961478
- Acronym / sponsor ID
- IOXSOR / PHRC2015-06
- Conditions
- Acute Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 11 Nov 2016 (estimated)
- 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.
IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iohexol plasmatic clearance | Experimental | Drug: IOHEXOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ICU stay > 7 days
- Having presented during the stay renal failure stage 2 or 3 Kidney Disease Improving Global Outcomes (KDIGO)
- Steady improvement of renal function before the ICU discharge :
- Expected discharge ICU within 48 hours :
- Informed consent signed by the patient, where not possible by the person of trust or the family if present. Written consent by the patient will be obtained as soon as deemed possible.
Key exclusion criteria (9 listed)
- Iohexol administration within 48 hours preceding the potential inclusion (imaging examination with X-ray contrast medium injection)
- Iohexol administration planned within 24 hours after potential inclusion in the study
- Known medical history of immediate allergic or delayed skin allergic reaction to injection of iodinated contrast material or any serious doubt on this medical history
- Patient receiving from extra renal purification during ICU discharge
- Chronic renal disease known (creatinine> 110 µmol / L for women,> 130 µmol / L for men) or creatinine clearance estimated less than 60 mL / min
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: Omnipaque ®Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure. | Drug | Iohexol plasmatic clearance |
Primary outcome
Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.
Time frame: 24 hours
Iohexol clearance pharmacokinetics
3 secondary outcomes
Correlation between non resolutive renal at the end of ICU (iohexol clearance < 60 ml/min/1m273) and creatinine clearance < 60 ml/min/1m273 at 6 month after ICU. discharge
Time frame: Six month after ICU discharge
Number of risk factors associated with non resolutive among : Age Previous renal function Comorbidities Severity parameters of renal aggression Acute severity of parameters during the ICU hospitalisation
Time frame: 24 hours
Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
François BELONCLE, CCU-AH principal investigator
University Hospital, Angers
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IOHEXOL in people with Acute Renal Failure, run by University Hospital, Angers at 11 sites 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation. (time frame: 24 hours). 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 Jun 2026.