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Not yet recruiting NCT07123324

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

Observational Acute Kidney Injury Kidney Failure Chronic Cardiorenal Syndrome Renal Replacement Therapies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Acute Kidney Injury, Kidney Failure Chronic, Cardiorenal Syndrome, Renal Replacement Therapies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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)

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07123324 · 9876

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗