Renal Injury, AcuteAKIRANCT07596407
Acute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment
An observational study of Renal Injury, Acute, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients who develop severe acute kidney injury (AKI) in intensive care remain at increased long-term risk of mortality, major cardiovascular events, and chronic renal complications, including prolonged dependence on renal replacement therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Injury, Acute
- How many people
- 412 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population comes from the AKIKI-2 cohort, which included adult patients (≥18 years) in intensive care, under mechanical ventilation and/or catecholamines, presenting severe acute renal failure (KDIGO 3) complicated by oligo-anuria ≥72 h or uremia between 40 and 50 mmol/L. For the present study, the eligible population is defined among patients surviving to day 60 since their inclusion, 412 subjects out of the 757 initially included. Of these 412 subjects, 214 recovered spontaneously during the observational phase, 57 had an EER initiated during the observational phase, and 141 participated in the randomized phase.
Who may be able to join
- The study population concerns patients included in the AKIKI 2 study who survive 60 days after inclusion in the AKIKI 2 study.
Who cannot join
- Patients opposed to their participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Réanimation médico-chirurgicale, Hôpital Avicenne
Bobigny
Khalil CHAIBI, Dr, 00 33 1 48 95 52 41, khalil.chaibi@aphp.fr
About this study
Official title: Long-term Renal and Cardiovascular Prognosis After Severe Acute Renal Failure in Intensive Care : Value of Biomarkers as Risk Stratification Tools
Patients who develop severe acute kidney injury (AKI) in intensive care remain at increased long-term risk of mortality, major cardiovascular events, and chronic renal complications, including prolonged dependence on renal replacement therapy. These adverse outcomes are thought to result from persistent inflammation, fibrosis, and cardio-renal interactions, which are not adequately captured by conventional clinical or biological markers.
This study is an ancillary analysis of the AKIKI 2 trial. The main objective is to assess whether biomarkers of inflammation and fibrosis, specifically galectin-3 (Gal-3) and CD146, measured during the acute phase of AKI, can predict and stratify long-term cardio-renal risk in patients who survived to day 60 after severe AKI in the ICU.
Read more
The primary endpoint is the occurrence, between day 60 and the last follow-up, of a composite cardio-renal outcome, defined as the first occurrence of:
- a major cardiovascular event (myocardial infarction, stroke, or hospitalization for heart failure),
- a major renal event (chronic dialysis dependence or progression to severe chronic kidney disease),
- or death from any cause.
Secondary objectives include :
- describing the long-term incidence of major renal events (MAKE),
- describing the incidence of major cardiovascular events (MACE),
- evaluating the predictive ability of Gal-3 and CD146 for the occurrence of MAKE,
- evaluating their ability to predict long-term MACE and deterioration of cardiovascular function.
The study population will include patients from the AKIKI 2 trial who are alive at day 60. Follow-up data (creatinine levels, dialysis dependence, cardiovascular events, etc.) will be collected through telephone interviews with patients and their referring physicians. When appropriate, a cardiology referral will be recommended as part of routine clinical care.
- Conditions
- Renal Injury, Acute
- Keywords
- cardiovascular events, renal events, chronic renal failure, dialysis
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients AKIKI2 | The study population will include patients from the AKIKI 2 trial who are alive at day 60. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, between 60 days after inclusion in the AKIKI 2 study and the date of the last news, of a composite cardio-renal criteria defined by the occurrence of a MACE and/or a MAKE criteria or death from all causes, the first event being retained
Composite criteria : occurrence, between day 60 (60 days after inclusion in the AKIKI 2 study) and the date of the last news, of a cardio-renal composite criteria defined by the occurrence of a major cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure) and/or a major renal event (dependence on chronic dialysis, progression to severe chronic renal failure) or death from all causes, the first event being retained.
Measured: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Secondary outcomes (3)
Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained
Occurrence, between day 60 (after inclusion in the AKIKI 2 study) and the date of the last news, of a MAKE criteria defined by dependence on chronic dialysis or by progression towards severe chronic renal failure (stage 4 or 5 KDIGO), the first event being retained
Measured: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained
Occurrence, between day 60 (after inclusion in the AKIKI 2 study) and the date of the last news, of a MACE criteria defined by a myocardial infarction or a stroke or hospitalization for heart failure, the first event being retained
Measured: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography
The diagnosis of heart failure will be established in the event of compatible clinical symptoms (dyspnea, congestive signs) with ultrasound :
- impaired LVEF under 40 %
- a moderately impaired LVEF, between 41 and 49%
- a preserved LVEF more than 50% associated with structural abnormalities (left ventricular hypertrophy, left atrial dilatation) and/or functional (elevation of left ventricular filling pressures and/or PAPs estimated > 35 mmHg or a Vmax > 2.8 m/s) in a context of increased natriuretic peptides (BNP > 35 ng/L or NT-proBNP > 125 ng/L)
Measured: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Injury, AcuteStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596407
- Sponsor's protocol ID
- APHP251915
- Acronym
- AKIRA
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Renal and Cardiovascular Prognosis After Severe Acute Renal Failure in Intensive Care : Value of Biomarkers as Risk Stratification Tools
- ClinicalTrials.gov ID
- NCT07596407
- Acronym / sponsor ID
- AKIRA / APHP251915
- Conditions
- Renal Injury, Acute
- Keywords
- cardiovascular events, renal events, chronic renal failure, dialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 19 May 2026 (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.
Patients who develop severe acute kidney injury (AKI) in intensive care remain at increased long-term risk of mortality, major cardiovascular events, and chronic renal complications, including prolonged dependence on renal replacement therapy. These adverse outcomes are thought to result from persistent inflammation, fibrosis, and cardio-renal interactions, which are not adequately captured by conventional clinical or biological markers.
This study is an ancillary analysis of the AKIKI 2 trial. The main objective is to assess whether biomarkers of inflammation and fibrosis, specifically galectin-3 (Gal-3) and CD146, measured during the acute phase of AKI, can predict and stratify long-term cardio-renal risk in patients who survived to day 60 after severe AKI in the ICU.
The primary endpoint is the occurrence, between day 60 and the last follow-up, of a composite cardio-renal outcome, defined as the first occurrence of:
- a major cardiovascular event (myocardial infarction, stroke, or hospitalization for heart failure),
- a major renal event (chronic dialysis dependence or progression to severe chronic kidney disease),
- or death from any cause.
Secondary objectives include :
- describing the long-term incidence of major renal events (MAKE),
- describing the incidence of major cardiovascular events (MACE),
- evaluating the predictive ability of Gal-3 and CD146 for the occurrence of MAKE,
- evaluating their ability to predict long-term MACE and deterioration of cardiovascular function.
The study population will include patients from the AKIKI 2 trial who are alive at day 60. Follow-up data (creatinine levels, dialysis dependence, cardiovascular events, etc.) will be collected through telephone interviews with patients and their referring physicians. When appropriate, a cardiology referral will be recommended as part of routine clinical care.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients AKIKI2 | – | –The study population will include patients from the AKIKI 2 trial who are alive at day 60. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population comes from the AKIKI-2 cohort, which included adult patients (≥18 years) in intensive care, under mechanical ventilation and/or catecholamines, presenting severe acute renal failure (KDIGO 3) complicated by oligo-anuria ≥72 h or uremia between 40 and 50 mmol/L. For the present study, the eligible population is defined among patients surviving to day 60 since their inclusion, 412 subjects out of the 757 initially included. Of these 412 subjects, 214 recovered spontaneously during the observational phase, 57 had an EER initiated during the observational phase, and 141 participated in the randomized phase.
Key inclusion criteria (1 listed)
- The study population concerns patients included in the AKIKI 2 study who survive 60 days after inclusion in the AKIKI 2 study.
Key exclusion criteria (1 listed)
- Patients opposed to their participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence, between 60 days after inclusion in the AKIKI 2 study and the date of the last news, of a composite cardio-renal criteria defined by the occurrence of a MACE and/or a MAKE criteria or death from all causes, the first event being retained
Time frame: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Composite criteria : occurrence, between day 60 (60 days after inclusion in the AKIKI 2 study) and the date of the last news, of a cardio-renal composite criteria defined by the occurrence of a major cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure) and/or a major renal event (dependence on chronic dialysis, progression to severe chronic renal failure) or death from all causes, the first event being retained.
3 secondary outcomes
Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained
Time frame: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained
Time frame: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography
Time frame: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Renal Injury, Acute, run by Assistance Publique - Hôpitaux de Paris 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khalil CHAIBI, Dr (00 33 1 48 95 52 41, khalil.chaibi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence, between 60 days after inclusion in the AKIKI 2 study and the date of the last news, of a composite cardio-renal criteria defined by the occurrence of a MACE and/or a MAKE criteria or death from all causes, the first event being retained (time frame: Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.). 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 19 May 2026.