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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968668
First Posted: October 24, 2013
Last Update Posted: January 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
October 21, 2013
October 24, 2013
January 9, 2015
October 2013
October 2014   (Final data collection date for primary outcome measure)
Change of urinary albumin-to creatinine ratio [ Time Frame: Baseline and 90 days ]
Same as current
Complete list of historical versions of study NCT01968668 on ClinicalTrials.gov Archive Site
Change in serum potassium concentration [ Time Frame: Baseline and 90 days ]
Same as current
Not Provided
Not Provided
 
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)
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)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Diabetic Nephropathies
  • 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
  • Drug: Placebo
    Placebo tablet once daily in the morning
  • 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: BAY94-8862 (1.25 mg)
    Intervention: Drug: BAY94-8862
  • Experimental: BAY94-8862 (2.5 mg)
    Intervention: Drug: BAY94-8862
  • Experimental: BAY94-8862 (5 mg )
    Intervention: Drug: BAY94-8862
  • Experimental: BAY94-8862 (7.5 mg)
    Intervention: Drug: BAY94-8862
  • Experimental: BAY94-8862 (10 mg)
    Intervention: Drug: BAY94-8862
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: BAY 94-8862 (15 mg)
    Intervention: Drug: BAY 94-8862
  • Experimental: BAY 94-8862 (20 mg)
    Intervention: Drug: BAY 94-8862
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
November 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01968668
16816
Yes
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP