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

NCT07123324 | Not Yet Recruiting

• 1 other identifier: 9876
• Study Type: observational
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Assessed at 12 months post-admission (±30 days)

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

  Assessed throughout the 12-month follow-up period

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

  Assessed at 12 months post-AKI hospitalization

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Mallaury Vervaeke

CONTACT

+33388616855; mallaury.vervaeke@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08