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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01874431
First received: June 7, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathies
Drug: Finerenone (BAY 94-8862)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 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: From baseline to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 821
Study Start Date: June 2013
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Finerenone (BAY 94-8862) (1.25 mg)
1.25 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(2.5 mg)
2.5 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(5 mg)
5 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(7.5 mg)
7.5 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862) (10 mg)
10 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862) (15 mg)
15 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Experimental: Finerenone (BAY 94-8862)(20 mg)
20 mg dose oral once daily for 90 days
Drug: Finerenone (BAY 94-8862)
Placebo Comparator: Placebo
Placebo oral dose once daily for 90 days
Drug: Placebo

  Eligibility

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

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
  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: NCT01874431

  Show 168 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01874431     History of Changes
Other Study ID Numbers: 16243, 2012-004179-38
Study First Received: June 7, 2013
Last Updated: August 14, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED - National Authority of Medicines and Health Products
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency

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

ClinicalTrials.gov processed this record on November 25, 2014