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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01968668
First received: October 21, 2013
Last updated: July 7, 2014
Last verified: July 2014
  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)


Condition Intervention Phase
Diabetic Nephropathies
Drug: BAY94-8862
Drug: Placebo
Drug: BAY 94-8862
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Change of urinary albumin-to creatinine ratio [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in serum potassium concentration [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: October 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAY94-8862 (1.25 mg) Drug: BAY94-8862
1.25 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (2.5 mg) Drug: BAY94-8862
2.5 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (5 mg ) Drug: BAY94-8862
5 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (7.5 mg) Drug: BAY94-8862
7.5 mg BAY94-8862 tablet once daily in the morning
Experimental: BAY94-8862 (10 mg) Drug: BAY94-8862
10 mg BAY94-8862 tablet once daily in the morning
Placebo Comparator: Placebo Drug: Placebo
Placebo 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
Experimental: BAY 94-8862 (20 mg) Drug: BAY 94-8862
20 mg BAY 94-8862 tablet once daily in the morning

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968668

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
Japan
Recruiting
Nagoya, Aichi, Japan, 466-0815
Recruiting
Nagoya, Aichi, Japan, 456-0058
Recruiting
Saijo, Ehime, Japan, 793-0027
Recruiting
Kurume, Fukuoka, Japan, 830-8522
Recruiting
Kurume, Fukuoka, Japan, 830-8543
Recruiting
Obihiro, Hokkaido, Japan, 080-0848
Recruiting
Amagasaki, Hyogo, Japan, 660-0828
Recruiting
Koga, Ibaraki, Japan, 306-0232
Recruiting
Tsuchiura, Ibaraki, Japan, 300-0835
Recruiting
Tsukuba, Ibaraki, Japan, 305-0812
Recruiting
Kahoku-gun, Ishikawa, Japan, 920-0293
Recruiting
Sakaide, Kagawa, Japan, 762-0007
Recruiting
Izumisano, Osaka, Japan, 598-8577
Recruiting
Yao, Osaka, Japan, 581-0011
Recruiting
Katsushika, Tokyo, Japan, 125-0054
Recruiting
Osaka, Japan, 530-0001
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01968668     History of Changes
Other Study ID Numbers: 16816
Study First Received: October 21, 2013
Last Updated: July 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
BAY94-8862
MR antagonist
Diabetic nephropathy
Japanese patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on July 24, 2014