A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Placebo in Japanese Type 2 Diabetic Patients with Microalbuminuria (ESAX-DN study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223639

Enrollment

400

Registered

2017-09-04

Start date

2017-09-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetic Patients with Microalbuminuria

Interventions

investigational material(s) Generic name etc : CS-3150 INN of investigational material : Esaxerenone (r-INN) Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years or older at the time obtaining informed consent 2) Patients diagnosed to have type 2 diabetes mellitus 3) Patients who meet any of the following in the laboratory tests (central measurement) at run in period. i.Patients with UACR >= 45 mg/g creatinine and = 30 mL/min/1.73 m2 4) Hypertensive patients who have been taking an ARB or an ACE inhibitor for at least 12 weeks prior to the study drug administration without changing the dosage and administration.

Exclusion criteria

Exclusion criteria: 1) Patients with type 1 diabetes mellitus 2) Patients with secondary glucose tolerance impairment 3) Patients diagnosed to have non-diabetic nephropathy 4) Patients with secondary hypertension 5) Patients who were hospitalized for hyperkalemia within 1 year before informed consent

Design outcomes

Primary

Measure	Time frame
efficacy UACR remission rate at the end of the treatment	—

Secondary

Measure	Time frame
efficacy 1.Change rate in UACR and eGFRcreat from baseline to the end of the treatment 2.Retention rate and duration of UACR remission 3.Progression rate to overt albuminuria 4.Time course of changes in UACR, eGFR, and blood pressure	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026