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)

Diabetic Nephropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968668
• Other study ID #: 16816
• Status: Completed
• Phase: Phase 2
• Start date: October 28, 2013
• Est. completion date: November 7, 2014

Study information

• Verified date: July 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 7, 2014
• Est. primary completion date: October 9, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
• BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
• BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
• BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
• BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
• Placebo
Placebo tablet once daily in the morning
• BAY 94-8862
15 mg BAY 94-8862 tablet once daily in the morning
• BAY 94-8862
20 mg BAY 94-8862 tablet once daily in the morning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of urinary albumin-to creatinine ratio		Baseline and 90 days
Secondary	Change in serum potassium concentration		Baseline and 90 days

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