Evidence map›Paper›PMID 41303298›Full record

Trial reportInternational journal of molecular sciences2025

Urine Extracellular Vesicle miRNA Changes Induced by Vicadrostat with/Without Empagliflozin in Patients with Chronic Kidney Disease.

Denis Delic, Isabella Gashaw, Ileana Duran-Fernandez, Lisa Cronin, Sibylle J Hauske, Peter Rossing, Katherine R Tuttle

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in International journal of molecular sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Denis DelicBoehringer Ingelheim Pharma GmbH & Co. KG, 88400 Biberach, Germany.ORCID 0000-0001-6798-3134
Isabella GashawBoehringer Ingelheim Pharma GmbH & Co. KG, 55216 Ingelheim am Rhein, Germany.ORCID 0000-0001-5984-576X
Ileana Duran-FernandezStaburo GmbH, 81549 Munich, Germany.
Lisa CroninBoehringer Ingelheim Pharmaceuticals, Ridgefield, CT 06877, USA.
Sibylle J HauskeFifth Department of Medicine (Nephrology/Endocrinology/Rheumatology), University Medical Centre Mannheim, University of Heidelberg, 68167 Heidelberg, Germany.
Peter RossingSteno Diabetes Center Copenhagen, 2730 Herlev, Denmark.
Katherine R TuttleProvidence Inland Northwest Health, Spokane, WA 99201, USA.ORCID 0000-0002-2235-0103

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vicadrostat, a selective aldosterone synthase inhibitor, reduced albuminuria with concurrent renin-angiotensin system inhibition and empagliflozin, suggesting additive efficacy for chronic kidney disease (CKD) treatment. Specific urinary extracellular vesicle microRNAs (uEV miRNAs) may reflect key mechanisms of kidney injury. We investigated how vicadrostat alone or with empagliflozin affected uEV miRNA expression in study participants. Small RNA sequencing was conducted on uEV miRNAs from 435 participants with CKD who completed 14 weeks treatment in the phase II trial of vicadrostat given with or without empagliflozin. Differentially expressed uEV miRNAs in participants with ≥30% UACR (urine albumin-creatinine ratio) reduction treated with 10 or 20 mg vicadrostat were pooled and evaluated with or without empagliflozin. Changes in miRNA-142-5p correlated significantly with changes in UACR in participants treated with vicadrostat alone, whereas changes in expression of eight additional uEV miRNAs (miR-192-5p, miR-194-5p, miR-6882-5p, miR-27a-5p, miR-381-3p, miR-192-3p, miR-513a-5p, and miR-199b-3p) correlated with ≥30% UACR improvements in patients treated with vicadrostat plus empagliflozin. Cellular deconvolution revealed that these miRNAs were expressed in various kidney cell types. Vicadrostat plus empagliflozin altered uEV miRNAs involved in immunomodulatory and fibrotic pathways irrespective of participant diabetes status. Regulation of miRNAs may provide insights into synergistic mechanisms of vicadrostat and empagliflozin in CKD treatment.

Indexed as

Benzhydryl CompoundsExtracellular VesiclesGlucosidesMicroRNAsRenal Insufficiency, ChronicAgedFemaleHumansMaleMiddle AgedSodium-Glucose Transporter 2 InhibitorsBenzhydryl CompoundsempagliflozinGlucosidesMicroRNAsSodium-Glucose Transporter 2 Inhibitorsalbuminuriaaldosterone synthase inhibitionbiomarkersdiabetesSGLT2 inhibition

Identifiers

PMID41303298
PMCPMC12652424

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.