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External Control Augmentation Increases Estimates Precision for Finerenone plus Sodium-Glucose Cotransporter-2

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  • 1Real World Evidence Center of Excellence, Global Medical & Evidence, Bayer AG, Berlin, Germany.

Kidney International Reports
|April 20, 2026
PubMed
Summary

This study used electronic health records to create an external control arm, enhancing precision for finerenone treatment effects in patients with chronic kidney disease and type 2 diabetes. The augmented data confirmed finerenone

Keywords:
chronic renal insufficiencydiabetes mellitus type 2electronic health recordsmineralocorticoid receptor antagonistssodium-glucose transporter 2 inhibitors

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Area of Science:

  • Cardiology
  • Nephrology
  • Pharmacology

Background:

  • The FIDELITY analysis demonstrated finerenone's complementary benefit with SGLT-2 inhibitors in type 2 diabetes and CKD patients.
  • Estimating finerenone's precise treatment effects was limited by comparator group representation in clinical trials.

Purpose of the Study:

  • To augment the FIDELITY trial's comparator group using US electronic health record data for an external control arm (ECA).
  • To enhance the statistical precision of finerenone's treatment effect estimates for cardiovascular and kidney outcomes.

Main Methods:

  • Identified eligible patients from EHR data matching FIDELITY inclusion criteria.
  • Matched 877 ECA patients 1:1 to FIDELITY SGLT-2i users using linear programming based on demographics and clinical factors.
  • Calculated finerenone's treatment effects on composite CV/kidney endpoints, HHF, and mortality using augmented data.

Main Results:

  • Matched ECA and FIDELITY SGLT-2i users showed minimal baseline differences (median ASMD 0.000).
  • ECA augmentation improved estimate precision, yielding narrower confidence intervals compared to original FIDELITY data.
  • Observed a significant benefit for finerenone + SGLT-2i subgroup versus augmented SGLT-2i controls for CV endpoint and HHF.

Conclusions:

  • An external control arm effectively augments underrepresented populations in cardiorenal trials.
  • ECA enhances statistical precision of treatment effect estimates when homogeneity with internal controls is sufficient.