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.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01968668
First received: October 21, 2013
Last updated: April 10, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968668

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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: April 10, 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 April 15, 2014