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)

Bayer

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathies

Treatments: Drug: BAY 94-8862; Drug: Placebo; Drug: BAY94-8862

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968668

16816

Details and patient eligibility

About

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)

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 8 patient groups, including a placebo group

BAY94-8862 (1.25 mg)

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

BAY94-8862 (2.5 mg)

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

BAY94-8862 (5 mg )

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

BAY94-8862 (7.5 mg)

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

BAY94-8862 (10 mg)

Experimental group

Treatment:

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Drug: BAY94-8862

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

BAY 94-8862 (15 mg)

Experimental group

Treatment:

Drug: BAY 94-8862

Drug: BAY 94-8862

BAY 94-8862 (20 mg)

Experimental group

Treatment:

Drug: BAY 94-8862

Drug: BAY 94-8862