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)

Phase 3

Completed

• Conditions: Type 2 Diabetic Patients with Microalbuminuria

• Registration Number: JPRN-jRCT2080223639
• Lead Sponsor: DAIICHI SANKYO Co.,Ltd.

Brief Summary

When CS-3150 was administered for 52 weeks to patients with type 2 diabetes and microalbuminuria taking ARB or ACE inhibitors, the superiority of CS-3150 over placebo was demonstrated in achieving and remission rate of UACR and UACR reduction. Also, progression rate to overt albuminuria in CS-3150 group was significantly lower than that in the placebo group. There were no apparent differences in the incidence of SAEs between CS-3150 and placebo groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-04
• Study Completion: 2019-04-26
• Results First Posted: 2020-11-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 455

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 < 300 mg/g creatinine in the early morning first urine at least twice.
ii. Patients with eGFRcreat >= 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>UACR remission rate at the end of the treatment

Secondary Outcome Measures

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