check_circleStudy Completed

Diabetic Nephropathies

Bayer Identifier:

16816

ClinicalTrials.gov Identifier:

NCT01968668

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

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)

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
October 2013 - November 2014
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Obihiro, 080-0848, Japan
Completed
Tsuchiura, 300-0835, Japan
Completed
Tsukuba, 305-0812, Japan
Completed
Katsushika, 125-0054, Japan
Completed
Kahoku-gun, 920-0293, Japan
Completed
Nagoya, 466-0815, Japan
Completed
Nagoya, 456-0058, Japan
Completed
Yao, 581-0011, Japan
Completed
Izumisano, 598-8577, Japan
Completed
Sakaide, 762-0007, Japan
Completed
Saijo, 793-0027, Japan
Completed
Kurume, 830-8522, Japan
Completed
Kurume, 830-8543, Japan
Completed
Koga, 306-0232, Japan
Completed
Osaka, 530-0001, Japan
Completed
Amagasaki, 660-8550, Japan

Primary Outcome

  • Change of urinary albumin-to creatinine ratio
    date_rangeTime Frame:
    Baseline and 90 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in serum potassium concentration
    date_rangeTime Frame:
    Baseline and 90 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
8

Additional Information

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