Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01968668

Enrollment

Registered

2013-10-24

Start date

2013-10-28

Completion date

2014-11-07

Last updated

2021-07-16

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

Conditions

Diabetic Nephropathies

Keywords

BAY94-8862, MR antagonist, Diabetic nephropathy, Japanese patients

Brief summary

This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design. Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)

Interventions

DRUGBAY94-8862

1.25 mg BAY94-8862 tablet once daily in the morning

DRUGPlacebo

Placebo tablet once daily in the morning

DRUGBAY 94-8862

15 mg BAY 94-8862 tablet once daily in the morning

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB) * Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria: * Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of \>/=300 mg/g (\>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m2 but \<90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or * Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g (\>/=3.4 mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR\>/=30 mL/min/1.73 m2 but \<90 mL/min/1.73 m2 (CKD-EPI) * Serum potassium \</=4.8 mmol/L at both the run-in visit and the screening visit

Exclusion criteria

* Non-diabetic renal disease (confirmed by biopsy) * Known bilateral clinically relevant renal artery stenosis (\>75%) * Glycated hemoglobin(HbA1c) \>12% at the run-in visit or the screening visit * UACR \>3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit * Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean sitting SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit * Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit * Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic

Design outcomes

Primary

Measure	Time frame
Change of urinary albumin-to creatinine ratio	Baseline and 90 days

Secondary

Measure	Time frame
Change in serum potassium concentration	Baseline and 90 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026