Feasibility of Decentralised Response-Guided Albuminuria Monitoring to Optimise Empagliflozin and Finerenone Therapy in Type 2 Diabetes and Chronic Kidney Disease.

AIMS: To assess the feasibility of a decentralised response-guided trial and to characterise urinary albumin-to-creatinine ratio (UACR) responses to empagliflozin and finerenone in type 2 diabetes and chronic kidney disease (CKD).

MATERIALS AND

METHODS

Adults with type 2 diabetes, estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m2, and UACR > 4.5 mg/mmol (> 40 mg/g) were enrolled in a decentralised response-guided trial. Participants completed study procedures remotely and received empagliflozin 10 mg once daily for 3 weeks. Based on predefined UACR response thresholds during empagliflozin treatment, participants entered a 4-week second treatment phase with continuation of empagliflozin, add-on finerenone or substitution with finerenone. Primary outcomes were feasibility measures, including participant-reported acceptability, sample delivery and completion of home measurements. Exploratory outcomes included changes in UACR.

RESULTS

Eleven participants completed the study (mean [SD] age 69.6 [6.1] years; mean eGFR 61.1 [24.8] mL/min/1.73 m2; median [IQR] UACR 246.9 mg/g [102.8-457.7]). All predefined feasibility criteria were met: urine and capillary blood sample delivery rates were 100% and 98.8%, respectively; home blood pressure and body weight completion rates were 91.3% and 98.6%. During empagliflozin monotherapy, UACR changed by -18.7% overall, after which nine participants (81.8%) initiated empagliflozin-finerenone combination therapy and 2 (18.2%) switched to finerenone monotherapy. UACR was further reduced by 40.1% after finerenone addition and by 34.0% after finerenone substitution, relative to the end of empagliflozin monotherapy. No serious adverse events or hyperkalaemia events were observed during treatment with empagliflozin, finerenone, or their combination.

CONCLUSIONS

A decentralised response-guided trial was feasible and safe, supporting further evaluation of this approach for individualised optimisation of kidney-protective therapy in type 2 diabetes and CKD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06094920.