Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01874431
First received: June 7, 2013
Last updated: June 5, 2014
Last verified: June 2014

June 7, 2013
June 5, 2014
June 2013
July 2014   (final data collection date for primary outcome measure)
Change of urinary albumin-to-creatinine ratio [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01874431 on ClinicalTrials.gov Archive Site
  • Change in serum potassium [ Time Frame: 7 days, 30 days, 60 days, 90 days ] [ Designated as safety issue: Yes ]
  • Change in renal function [ Time Frame: 30 days, 60 days, 90 days ] [ Designated as safety issue: Yes ]
  • Change in health-related quality of life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Health-related quality of life is assessed by the scores got from the Kidney Disease Quality of Life (KDQOL-36) and EuroQol Group 5 dimension, 3 level (EQ-5D-3L) questionnaires.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it is safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses will be compared to placebo.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Nephropathies
  • Drug: Finerenone (BAY 94-8862)
  • Drug: Placebo
  • Experimental: Finerenone (BAY 94-8862) (1.25 mg)
    1.25 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Experimental: Finerenone (BAY 94-8862)(2.5 mg)
    2.5 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Experimental: Finerenone (BAY 94-8862)(5 mg)
    5 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Experimental: Finerenone (BAY 94-8862)(7.5 mg)
    7.5 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Experimental: Finerenone (BAY 94-8862) (10 mg)
    10 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Experimental: Finerenone (BAY 94-8862) (15 mg)
    15 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Experimental: Finerenone (BAY 94-8862)(20 mg)
    20 mg dose oral once daily for 90 days
    Intervention: Drug: Finerenone (BAY 94-8862)
  • Placebo Comparator: Placebo
    Placebo oral dose once daily for 90 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
745
August 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
  • Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
  • Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

    • are on oral antidiabetics and / or insulin,
    • have a documented fasting glucose >/= 7.0 mmol/L in the medical history,
    • have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
    • have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)] in the medical history or at the run-in visit
  • 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/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
    • Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in (>/=3.4mg/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/1.73m²
  • Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
  • Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

  • Non-diabetic renal disease
  • Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit
  • UACR >3000 mg/g (339mg/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 supine 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
  • Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   South Africa,   Spain,   Sweden,   Taiwan
 
NCT01874431
16243, 2012-004179-38
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2014

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