Acute Kidney InjuryFAKIRNCT07123324
French AKI Registry (FAKIR): A Multicenter Study on the In-Hospital Management and Outcomes of Severe Acute Kidney Injury in Nephrology Units
An observational study of Acute Kidney Injury and Kidney Failure Chronic, run by University Hospital, Strasbourg, France.
Trial summary
Acute Kidney Injury (AKI) is a common and serious condition in hospitalized patients, especially when it reaches stages 2 or 3 according to the KDIGO classification. These severe forms are associated with high mortality, a risk of progression to chronic kidney disease (CKD), and frequent cardiovascular complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Kidney Failure Chronic, Cardiorenal Syndrome
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Aug 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years) hospitalized in nephrology departments across multiple French university hospitals for acute kidney injury (AKI) stage 2 or 3. Patients are identified prospectively at the time of admission to nephrology units, either directly or via transfer from emergency or other hospital departments. Only patients with confirmed KDIGO stage 2 or 3 AKI at admission are included. Data are collected during hospitalization and up to 12 months post-discharge to assess renal and cardiovascular outcomes.
Who may be able to join
- Age ≥ 18 years at admission
- Hospitalized in a nephrology ward (standard or intensive nephrology care unit)
- Diagnosis of acute kidney injury (AKI) stage 2 or 3 according to KDIGO criteria at the time of admission
- Availability of follow-up data at 3 months (clinical or laboratory)
Who cannot join
- AKI stage 1 only
- AKI acquired outside the nephrology department without subsequent transfer to nephrology
- Hospitalized for another reason without documented AKI stage 2 or 3
- Refusal or opposition to data reuse for research purposes
- Under legal protection (guardianship or trusteeship) without a representative to provide non-opposition
- Incomplete medical records preventing collection of required baseline data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Multicenter Observational Study of the Management and Prognosis of Severe Acute Kidney Injury (AKI) in Nephrology Units: The French AKI Registry (FAKIR)
Acute Kidney Injury (AKI) is a common and serious condition in hospitalized patients, especially when it reaches stages 2 or 3 according to the KDIGO classification. These severe forms are associated with high mortality, a risk of progression to chronic kidney disease (CKD), and frequent cardiovascular complications. However, current data on how nephrologists manage these patients during hospitalization-and how these practices influence long-term outcomes-are limited and heterogeneous.
The FAKIR study (French AKI Registry) is a prospective, multicenter, non-interventional observational study designed to describe the clinical management of patients admitted to nephrology departments for AKI stage 2 or 3 and to assess their renal and cardiovascular outcomes up to one year. The study hypothesizes that better characterization of in-hospital practices and patient trajectories will help identify predictors of renal recovery, progression to end-stage renal disease, and major cardiovascular events.
Patients will be followed during hospitalization and at 3, 6, and 12 months to assess renal function, mortality, cardiovascular events, and rehospitalizations. This registry aims to provide real-life, multicenter data to support future guidelines and the development of structured post-AKI care pathways.
- Conditions
- Acute Kidney Injury, Kidney Failure Chronic, Cardiorenal Syndrome, Renal Replacement Therapies, Hospitalizations
- Keywords
- Kidney injury, Renal function recovery, Dialysis initiation, Kidney biopsy, Cardiovascular complications, Nephrology care, Renal prognosis, Renal cohort, Kidney follow-up, Kidney disease progression
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Cardio-Renal Syndrome
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 |
|---|---|---|
| AKI KDIGO 2-3 Nephrology Patients | This cohort includes adult patients (≥18 years old) hospitalized in nephrology wards (including conventional units and nephrology intensive care) for acute kidney injury (AKI) classified as KDIGO stage 2 or 3 at admission. Patients with AKI acquired outside nephrology or limited to stage 1 are excluded. Clinical data will be collected during hospitalization and follow-up visits at 3, 6, and 12 months to assess renal recovery, progression to chronic kidney disease, major cardiovascular events, and mortality. This group represents real-life management of severe AKI in nephrology units across multiple centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Complete Renal Recovery at 3 Months After Hospitalization for AKI KDIGO Stage 2 or 3
Renal recovery is defined as a return of serum creatinine to ≤125% of the patient's baseline (pre-AKI) value, estimated using the CKD-EPI formula. Creatinine values are collected from medical records or follow-up labs performed at 3 months post-discharge. This outcome reflects the extent of renal function recovery following hospitalization for severe AKI and helps identify prognostic factors associated with favorable evolution.
Measured: Assessed at 3 months (±30 days) after admission for AKI in nephrology ward
Secondary outcomes (3)
All-Cause Mortality at 12 Months After Hospitalization for AKI KDIGO Stage 2 or 3
All-cause mortality is defined as the proportion of patients who die from any cause within 12 months following their admission for AKI KDIGO stage 2 or 3. Vital status is obtained from hospital records, follow-up contact, or national registries. This outcome will allow assessment of medium-term prognosis and identification of clinical factors associated with mortality in patients with severe AKI managed in nephrology units.
Measured: Assessed at 12 months post-admission (±30 days)
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
MACE includes non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute heart failure, and cardiovascular death. Events will be identified from medical records, discharge summaries, and follow-up contacts. This outcome will assess the cardiovascular burden among patients with severe AKI managed in nephrology settings, and help determine the link between in-hospital management strategies and long-term cardiovascular risk.
Measured: Assessed throughout the 12-month follow-up period
Progression to End-Stage Renal Disease (ESRD) at 12 Months
ESRD is defined as the initiation of chronic renal replacement therapy (dialysis or kidney transplantation) or a sustained eGFR <15 mL/min/1.73m². Data are collected through follow-up visits, patient contact, or hospital records. This measure evaluates long-term renal outcomes and identifies risk factors for irreversible kidney failure following AKI KDIGO stage 2 or 3.
Measured: Assessed at 12 months post-AKI hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123324
- Sponsor's protocol ID
- 9876
- Acronym
- FAKIR
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study of the Management and Prognosis of Severe Acute Kidney Injury (AKI) in Nephrology Units: The French AKI Registry (FAKIR)
- ClinicalTrials.gov ID
- NCT07123324
- Acronym / sponsor ID
- FAKIR / 9876
- Conditions
- Acute Kidney Injury, Kidney Failure Chronic, Cardiorenal Syndrome, Renal Replacement Therapies, Hospitalizations
- Keywords
- Kidney injury, Renal function recovery, Dialysis initiation, Kidney biopsy, Cardiovascular complications, Nephrology care, Renal prognosis, Renal cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 14 Aug 2025 (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 (AKI) is a common and serious condition in hospitalized patients, especially when it reaches stages 2 or 3 according to the KDIGO classification. These severe forms are associated with high mortality, a risk of progression to chronic kidney disease (CKD), and frequent cardiovascular complications. However, current data on how nephrologists manage these patients during hospitalization-and how these practices influence long-term outcomes-are limited and heterogeneous.
The FAKIR study (French AKI Registry) is a prospective, multicenter, non-interventional observational study designed to describe the clinical management of patients admitted to nephrology departments for AKI stage 2 or 3 and to assess their renal and cardiovascular outcomes up to one year. The study hypothesizes that better characterization of in-hospital practices and patient trajectories will help identify predictors of renal recovery, progression to end-stage renal disease, and major cardiovascular events.
Patients will be followed during hospitalization and at 3, 6, and 12 months to assess renal function, mortality, cardiovascular events, and rehospitalizations. This registry aims to provide real-life, multicenter data to support future guidelines and the development of structured post-AKI care pathways.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AKI KDIGO 2-3 Nephrology Patients | – | –This cohort includes adult patients (≥18 years old) hospitalized in nephrology wards (including conventional units and nephrology intensive care) for acute kidney injury (AKI) classified as KDIGO stage 2 or 3 at admission. Patients with AKI acquired outside nephrology or limited to stage 1 are excluded. Clinical data will be collected during hospitalization and follow-up visits at 3, 6, and 12 months to assess renal recovery, progression to chronic kidney disease, major cardiovascular events, and mortality. This group represents real-life management of severe AKI in nephrology units across multiple centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) hospitalized in nephrology departments across multiple French university hospitals for acute kidney injury (AKI) stage 2 or 3. Patients are identified prospectively at the time of admission to nephrology units, either directly or via transfer from emergency or other hospital departments. Only patients with confirmed KDIGO stage 2 or 3 AKI at admission are included. Data are collected during hospitalization and up to 12 months post-discharge to assess renal and cardiovascular outcomes.
Key inclusion criteria (4 listed)
- Age ≥ 18 years at admission
- Hospitalized in a nephrology ward (standard or intensive nephrology care unit)
- Diagnosis of acute kidney injury (AKI) stage 2 or 3 according to KDIGO criteria at the time of admission
- Availability of follow-up data at 3 months (clinical or laboratory)
Key exclusion criteria (6 listed)
- AKI stage 1 only
- AKI acquired outside the nephrology department without subsequent transfer to nephrology
- Hospitalized for another reason without documented AKI stage 2 or 3
- Refusal or opposition to data reuse for research purposes
- Under legal protection (guardianship or trusteeship) without a representative to provide non-opposition
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
Rate of Complete Renal Recovery at 3 Months After Hospitalization for AKI KDIGO Stage 2 or 3
Time frame: Assessed at 3 months (±30 days) after admission for AKI in nephrology ward
Renal recovery is defined as a return of serum creatinine to ≤125% of the patient's baseline (pre-AKI) value, estimated using the CKD-EPI formula. Creatinine values are collected from medical records or follow-up labs performed at 3 months post-discharge. This outcome reflects the extent of renal function recovery following hospitalization for severe AKI and helps identify prognostic factors associated with favorable evolution.
3 secondary outcomes
All-Cause Mortality at 12 Months After Hospitalization for AKI KDIGO Stage 2 or 3
Time frame: Assessed at 12 months post-admission (±30 days)
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
Time frame: Assessed throughout the 12-month follow-up period
Progression to End-Stage Renal Disease (ESRD) at 12 Months
Time frame: Assessed at 12 months post-AKI hospitalization
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 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Kidney Failure Chronic, run by University Hospital, Strasbourg, 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 4 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: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Mallaury Vervaeke (+33388616855, mallaury.vervaeke@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Complete Renal Recovery at 3 Months After Hospitalization for AKI KDIGO Stage 2 or 3 (time frame: Assessed at 3 months (±30 days) after admission for AKI in nephrology ward). 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 14 Aug 2025.