A Study of CS-3150 to Evaluate Safety in Japanese Type 2 Diabetic Patients with Macroalbuminuria

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223640

Enrollment

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 macroalbuminuria

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 >= 300 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
safety efficacy 1. Proportion of each adverse event 2. Change in clinical laboratory parameters, vital sign 3. Time course of changes in UACR, eGFR, and blood pressure 4. Inprovement rate from macroalbuminuria to microalbuminuria	—

Countries

Japan

Outcome results

None listed

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