Chronic Kidney DiseasesIRA CibleNCT03192189
Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations
An observational study of Chronic Kidney Diseases and Acute Kidney Injury, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease. Recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Acute Kidney Injury
- What is being tested?
- monitoring for progression to chronic kidney disease
- How many people
- 319 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2016to 15 Jun 2018
- Phase
- Observational
- 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
Study population: Patients undergoing dialysis for acute kidney injury. All new adults (>18 years old) hospitalized in a university center with severe AKI was included from August 2016 to December 2017. Inclusion criteria was a severe AKI defined by dialysis start for AKI or an increase of Scr upper 354 μmol/L. Exclusion criteria was CKD stage 5 , patients living with kidney transplant, plan dialysis for bilateral surgery nephrectomy, patient witch justice protection and refuse to participate. Eligible patients were identified by physicians for ICU and nephrology department and by laboratory biochemistry department for others wards. A Biochemistry alert system controlled the exhaustively of inclusion in ICU and Nephrology department during the period of the study.
Who may be able to join
- Age >18 years
- Suffering from acute kidney injury treated with dialysis
- hospitalized in a university center from August 2016 to December 2017 with severe AKI defined according to 2 of the 3 criterion definitions of KDIGO stage AKI: an increase in SCr above 354 μmol/Lor renal replacement therapy (RRT) indication, but not the 3-fold increase in SCr increase within 7 days with SCr below 354 μmol/L.
- The patient has been informed and does not oppose the study
- The patient is insured or the beneficiary of a health insurance policy
Who cannot join
- The patients is under judicial protection or state guardianship
- Patient has chronic kidney disease(CKD) KDIGO stage 5
- It proves impossible to give the patient clear information
- patients living with kidney transplant
- plan dialysis for bilateral surgery nephrectomy
- patient refuse to participate and patients with no health insurance
Trial locations and contacts
1 site in 1 country.
About this study
Acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease. Recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization. Risk factors of developing chronic kidney disease between hospital visits are understudied.
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury
- Being tested
- monitoring for progression to chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring for progression to chronic kidney diseaseOther
Collect clinical information and assess risk factors
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute kidney injury | Requiring treatment with dialysis Receives: Other: monitoring for progression to chronic kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a prognostic score of progression to chronic kidney disease at 6 months in patients requiring hospitalization for dialysis for acute kidney injury to identify those who would benefit from consultation with a nephrologist
Measured: 6 months
Secondary outcomes (5)
Identify new risk factors for progression to chronic kidney disease at 6 months post dialysis for acute kidney injury pre-hospitalization and during hospitalization and day of discharge
Measured: 6 months
Identify renal phenotype of patients with chronic kidney disease
characterization from renal biopsy
Measured: 6 months
Evaluate mortality during hospital stay
Measured: 1 months
Evaluate mortality at medium-term
Measured: 6 months
Identify specific therapeutic interventions put into place during the 6 month consultation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start20 Aug 2016
- Primary completion31 Dec 2017
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192189
- Sponsor's protocol ID
- LOCAL/2016/OM-01
- Acronym
- IRA Cible
- Status last verified
- Nov 2025
- First submitted
- 16 Jun 2017
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cardinale A, Messikh Z, Antoine V, Aglae C, Reboul P, Cariou S, Muller L, Lefrant JY, Moranne O. Specificity of severe AKI aetiology and care in the elderly. The IRACIBLE prospective cohort study. J Nephrol. 2022 Nov;35(8):2097-2108. doi: 10.1007/s40620-022-01322-z. Epub 2022 May 3.
PubMed 35503200
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations
- ClinicalTrials.gov ID
- NCT03192189
- Acronym / sponsor ID
- IRA Cible / LOCAL/2016/OM-01
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 20 Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 20 Jun 2017 (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.
Acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease. Recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization. Risk factors of developing chronic kidney disease between hospital visits are understudied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute kidney injury | – | Other: monitoring for progression to chronic kidney diseaseRequiring treatment with dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing dialysis for acute kidney injury. All new adults (>18 years old) hospitalized in a university center with severe AKI was included from August 2016 to December 2017. Inclusion criteria was a severe AKI defined by dialysis start for AKI or an increase of Scr upper 354 μmol/L. Exclusion criteria was CKD stage 5 , patients living with kidney transplant, plan dialysis for bilateral surgery nephrectomy, patient witch justice protection and refuse to participate. Eligible patients were identified by physicians for ICU and nephrology department and by laboratory biochemistry department for others wards. A Biochemistry alert system controlled the exhaustively of inclusion in ICU and Nephrology department during the period of the study.
Key inclusion criteria (5 listed)
- Age >18 years
- Suffering from acute kidney injury treated with dialysis
- hospitalized in a university center from August 2016 to December 2017 with severe AKI defined according to 2 of the 3 criterion definitions of KDIGO stage AKI: an increase in SCr above 354 μmol/Lor renal replacement therapy (RRT) indication, but not the 3-fold increase in SCr increase within 7 days with SCr below 354 μmol/L.
- The patient has been informed and does not oppose the study
- The patient is insured or the beneficiary of a health insurance policy
Key exclusion criteria (6 listed)
- The patients is under judicial protection or state guardianship
- Patient has chronic kidney disease(CKD) KDIGO stage 5
- It proves impossible to give the patient clear information
- patients living with kidney transplant
- plan dialysis for bilateral surgery nephrectomy
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 |
|---|---|---|
| monitoring for progression to chronic kidney diseaseCollect clinical information and assess risk factors | Other | Patients with acute kidney injury |
Primary outcome
Develop a prognostic score of progression to chronic kidney disease at 6 months in patients requiring hospitalization for dialysis for acute kidney injury to identify those who would benefit from consultation with a nephrologist
Time frame: 6 months
5 secondary outcomes
Identify new risk factors for progression to chronic kidney disease at 6 months post dialysis for acute kidney injury pre-hospitalization and during hospitalization and day of discharge
Time frame: 6 months
Identify renal phenotype of patients with chronic kidney disease
Time frame: 6 months
Evaluate mortality during hospital stay
Time frame: 1 months
Evaluate mortality at medium-term
Time frame: 6 months
Identify specific therapeutic interventions put into place during the 6 month consultation
Time frame: 6 months
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 17 Nov 2025.
- Results publication: PubMed 35503200Cardinale A, Messikh Z, Antoine V, Aglae C, Reboul P, Cariou S, Muller L, Lefrant JY, Moranne O. Specificity of severe AKI aetiology and care in the elderly. The IRACIBLE prospective cohort study. J Nephrol. 2022 Nov;35(8):2097-2108. doi: 10.1007/s40620-022-01322-z. Epub 2022 May 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Acute Kidney Injury, run by Centre Hospitalier Universitaire de Nīmes 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 5 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: finished, as of the sponsor's last update on 17 Nov 2025. 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.
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?
Develop a prognostic score of progression to chronic kidney disease at 6 months in patients requiring hospitalization for dialysis for acute kidney injury to identify those who would benefit from consultation with a nephrologist (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192189, which also lists 1 linked publication.
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 17 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.