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

NCT ID: NCT07123324

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2028-08-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mallaury Vervaeke

Role: CONTACT

mallaury.vervaeke@chru-strasbourg.fr

+33388616855

Other Identifiers

9876

Identifier Type: -

Identifier Source: org_study_id