French AKI Registry (FAKIR): A Multicenter Study on the In-Hospital Management and Outcomes of Severe Acute Kidney Injury in Nephrology Units

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Kidney Injury Cardio-Renal Syndrome Cardiorenal Syndrome Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Hospitalizations Kidney Diseases Kidney Failure Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Replacement Therapies Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

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)

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.
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months

Time frame: Assessed throughout the 12-month follow-up period

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.
Progression to End-Stage Renal Disease (ESRD) at 12 Months

Time frame: Assessed at 12 months post-AKI hospitalization

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mallaury Vervaeke

CONTACT

[email protected]

+33388616855

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Prospective Multicenter Observational Study of the Management and Prognosis of Severe Acute Kidney Injury (AKI) in Nephrology Units: The French AKI Registry (FAKIR)

Acronym: FAKIR

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Aug 14, 2025
Registry last updated: Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting