A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients with Diabetic Kidney Disease

RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients with Diabetic Kidney Disease)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223898

Enrollment

950

Registered

2018-05-11

Start date

2018-05-15

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

Diabetic Kidney Disease

Interventions

investigational material(s) Generic name etc : RTA 402 INN of investigational material : - Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational mat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with DKD - Mean eGFR >= 15 and < 60 mL/min/1.73 m^2 - Albumin/creatinine ratio (ACR) =< 3500 mg/g Cr - Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication

Exclusion criteria

Exclusion criteria: - Diabetes mellitus that is neither type 1 nor type 2 - Decreased renal function mainly attributed to a non-diabetic cause - History of renal transplantation or upcoming preemptive renal transplantation - Confirmed mean systolic blood pressure > 160 mmHg or a confirmed mean diastolic blood pressure > 90 mmHg during the 8-week period before screening - Hemoglobin A1c level > 10.0% during screening - Serum albumin level = 200 pg/mL during screening

Design outcomes

Primary

Measure	Time frame
efficacy Efficacy Time to onset of a >= 30% decrease in eGFR from baseline or ESRD	—

Secondary

Measure	Time frame
safety efficacy Efficacy Important secondary endpoint - Time to onset of a >= 40% decrease in eGFR from baseline or ESRD Other secondary endpoints - Time to onset of a >= 53% decrease in eGFR from baseline or ESRD - Time to onset of ESRD - Change in eGFR from baseline at each evaluation time point	—

Countries

Japan

Outcome results

None listed

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