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)

July 15, 2021 updated by: Bayer

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablet once daily in the morning
Experimental: BAY94-8862 (1.25 mg)
Drug: BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (2.5 mg)
Drug: BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (5 mg )
Drug: BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (7.5 mg)
Drug: BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (10 mg)
Drug: BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
Drug: BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY 94-8862 (15 mg)
Drug: BAY 94-8862
15 mg BAY 94-8862 tablet once daily in the morning
Drug: BAY 94-8862
20 mg BAY 94-8862 tablet once daily in the morning
Experimental: BAY 94-8862 (20 mg)
Drug: BAY 94-8862
15 mg BAY 94-8862 tablet once daily in the morning
Drug: BAY 94-8862
20 mg BAY 94-8862 tablet once daily in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of urinary albumin-to creatinine ratio
Time Frame: Baseline and 90 days
Baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum potassium concentration
Time Frame: Baseline and 90 days
Baseline and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2013

Primary Completion (Actual)

October 9, 2014

Study Completion (Actual)

November 7, 2014

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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