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Trial record 1 of 1 for:    NCT01874431
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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)

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ClinicalTrials.gov Identifier: NCT01874431
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : May 4, 2021
Last Update Posted : July 1, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: Finerenone (BAY94-8862) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 823 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : June 12, 2013
Actual Primary Completion Date : July 9, 2014
Actual Study Completion Date : August 7, 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Finerenone (BAY94-8862) (1.25 mg)
1.25 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Experimental: Finerenone (BAY94-8862)(2.5 mg)
2.5 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Experimental: Finerenone (BAY94-8862)(5 mg)
5 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Experimental: Finerenone (BAY94-8862)(7.5 mg)
7.5 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Experimental: Finerenone (BAY94-8862) (10 mg)
10 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Experimental: Finerenone (BAY94-8862) (15 mg)
15 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Experimental: Finerenone (BAY94-8862)(20 mg)
20 mg dose oral once daily for 90 days
 Drug: Finerenone (BAY94-8862)
Placebo Comparator: Placebo
Placebo oral dose once daily for 90 days
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of UACR at Day 90 to UACR at Baseline [ Time Frame: Baseline and Day 90±2 ]
    Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.


Secondary Outcome Measures :
  1. Change From Baseline to Day 90 in Serum Potassium [ Time Frame: Baseline and Day 90±2 ]
  2. Change From Baseline to Day 90 in eGFR [ Time Frame: Baseline and Day 90±2 ]
    An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

  3. Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) [ Time Frame: Baseline and Day 90±2 ]
    The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.

  4. Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) [ Time Frame: Baseline and Day 90±2 ]
    EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874431


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01874431    
Other Study ID Numbers: 16243
2012-004179-38 ( EudraCT Number )
First Posted: June 11, 2013    Key Record Dates
Results First Posted: May 4, 2021
Last Update Posted: July 1, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications