Evidence map›Paper›PMID 33239409›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2020

Esaxerenone (CS-3150) in Patients with Type 2 Diabetes and Microalbuminuria (ESAX-DN): Phase 3 Randomized Controlled Clinical Trial.

Sadayoshi Ito, Naoki Kashihara, Kenichi Shikata, Masaomi Nangaku, Takashi Wada, Yasuyuki Okuda, Tomoko Sawanobori

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 8 pooled it
16.7field-weighted citation impact, top 1% of its field
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

114 citing papers in PubMed, 8 syntheses or guidelines pooled it, 212 citations in OpenAlex.

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  6. The association between dual RAAS inhibition and risk of acute kidney injury and hyperkalemia in patients with diabetic kidney disease: a systematic review and meta-analysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
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  16. The renoprotective effect of esaxerenone independent of blood pressure lowering: a post hoc mediation analysis of the ESAX-DN trial.Hypertension research : official journal of the Japanese Society of Hypertension · 2023
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  20. Aldosterone synthase inhibitors: a new option for antihypertensive, cardio-renal protection.Hypertension research : official journal of the Japanese Society of Hypertension · 2026
    Review

54 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 1 country.

Sadayoshi ItoDivision of Nephrology, Endocrinology and Vascular Medicine, Department of Medicine, Tohoku University School of Medicine, Sendai, Japan.
Naoki KashiharaDepartment of Nephrology and Hypertension, Kawasaki Medical School, Kurashiki, Japan.
Kenichi ShikataCenter for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.
Masaomi NangakuDivision of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Takashi WadaDepartment of Nephrology and Laboratory Medicine, Kanazawa University, Kanazawa, Japan.
Yasuyuki OkudaBiostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Tomoko SawanoboriClinical Development Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Daiichi-Sankyo (Japan) · JPKanazawa University · JPKawasaki Medical School · JPOkayama University Hospital · JPThe University of Tokyo · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesDiabetic kidney disease is an important complication of type 2 diabetes. In a phase 2b study, adding esaxerenone to renin-angiotensin system inhibitors dose dependently reduced the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and microalbuminuria. This 52-week phase 3 study further investigated the effects of esaxerenone on the urinary albumin-to-creatinine ratio in this patient group. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this multicenter, randomized, double-blind study, patients with type 2 diabetes and a urinary albumin-to-creatinine ratio of 45 to <300 mg/g creatinine treated with renin-angiotensin system inhibitors were randomized to esaxerenone or placebo for 52 weeks (

resultsOverall, 49 (22%) and nine (4%) patients in the esaxerenone and placebo groups, respectively, achieved urinary albumin-to-creatinine ratio remission (absolute difference 18%; 95% confidence interval, 12% to 25%;

conclusionsAdding esaxerenone to existing renin-angiotensin system inhibitor therapy in patients with type 2 diabetes and microalbuminuria increased the likelihood of albuminuria returning to normal levels, and reduced progression of albuminuria to higher levels.

Indexed as

AgedAlbuminuriaBiomarkersCreatinineDiabetes Mellitus, Type 2FemaleHumansJapanKidneyMaleMiddle AgedMineralocorticoid Receptor AntagonistsPyrrolesRemission InductionRisk FactorsSulfonesBiomarkersCreatinineesaxerenoneMineralocorticoid Receptor AntagonistsPyrrolesSulfonesdiabetes mellitusesaxerenonemicroalbuminuria

Identifiers

PMID33239409
PMCPMC7769030
OpenAlexW3107151441

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.