Trial Condition(s):

Diabetic Nephropathies

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 Identifier:

16816

ClinicalTrials.gov Identifier:

NCT01968668

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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)

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 Summary

Enrollment Goal
96
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
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Locations

Investigative Site

Obihiro, Japan, 080-0848

Status
Completed
 
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Investigative Site

Tsuchiura, Japan, 300-0835

Status
Completed
 
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Tsukuba, Japan, 305-0812

Status
Completed
 
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Katsushika, Japan, 125-0054

Status
Completed
 
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Investigative Site

Kahoku-gun, Japan, 920-0293

Status
Completed
 
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Nagoya, Japan, 466-0815

Status
Completed
 
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Nagoya, Japan, 456-0058

Status
Completed
 
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Yao, Japan, 581-0011

Status
Completed
 
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Izumisano, Japan, 598-8577

Status
Completed
 
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Sakaide, Japan, 762-0007

Status
Completed
 
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Saijo, Japan, 793-0027

Status
Completed
 
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Investigative Site

Kurume, Japan, 830-8522

Status
Completed
 
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Kurume, Japan, 830-8543

Status
Completed
 
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Koga, Japan, 306-0232

Status
Completed
 
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Investigative Site

Osaka, Japan, 530-0001

Status
Completed
 
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Investigative Site

Amagasaki, Japan, 660-8550

Status
Completed
 

Trial Design