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Candidate Surrogate End Points for ESRD after AKI.

Morgan E Grams1, Yingying Sang2, Josef Coresh3

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Summary
This summary is machine-generated.

A 30%-40% eGFR decline after acute kidney injury (AKI) may predict end-stage renal disease (ESRD). This finding could support AKI treatments and prevention trials by offering a new surrogate endpoint. Further research is needed.

Keywords:
acute renal failureend stage kidney diseaseglomerular filtration rate

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Area of Science:

  • Nephrology
  • Clinical Trials
  • Renal Disease Research

Background:

  • Acute kidney injury (AKI) is often temporary and not accepted as a trial endpoint by regulatory bodies.
  • Existing research lacks validated intermediate-term endpoints for AKI drug development.
  • The US Food and Drug Administration (FDA) requires robust endpoints for drug approval.

Purpose of the Study:

  • To evaluate if intermediate-term estimated glomerular filtration rate (eGFR) decline after AKI can predict end-stage renal disease (ESRD).
  • To determine the suitability of eGFR change as a surrogate endpoint in AKI prevention and treatment trials.
  • To analyze the association between post-AKI eGFR decline and subsequent ESRD and mortality.

Main Methods:

  • Retrospective cohort study of 161,185 US veterans undergoing major surgery (2004-2011).
  • In-hospital AKI classified using Kidney Disease Improving Global Outcomes (KDIGO) creatinine criteria.
  • eGFR decline assessed from pre-hospitalization to post-discharge (30, 60, 90 days).
  • Association of eGFR decline with ESRD and mortality analyzed over a median of 3.8 years.

Main Results:

  • 15.9% of AKI survivors experienced a ≥30% eGFR decline at 30 days, versus 3.1% without AKI.
  • A 30% eGFR decline at 90 days post-discharge showed an adjusted hazard ratio of 7.27 for ESRD (95% CI: 5.14 to 10.27).
  • A 40% eGFR decline at 90 days showed an adjusted hazard ratio of 10.95 for ESRD (95% CI: 8.10 to 14.82).
  • Consistent but smaller associations observed for mortality risk.

Conclusions:

  • A 30%-40% decline in eGFR following AKI is strongly associated with increased risk of ESRD.
  • This eGFR decline may serve as a potential surrogate endpoint for ESRD in AKI clinical trials.
  • Further clinical trial evidence is necessary to validate this surrogate endpoint for AKI interventions.