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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01874431




Registration number
NCT01874431
Ethics application status
Date submitted
7/06/2013
Date registered
11/06/2013
Date last updated
1/07/2021

Titles & IDs
Public title
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
Scientific 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
Secondary ID [1] 0 0
2012-004179-38
Secondary ID [2] 0 0
16243
Universal Trial Number (UTN)
Trial acronym
ARTS-DN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Nephropathies 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (BAY94-8862)
Treatment: Drugs - Placebo

Experimental: Finerenone (BAY94-8862) (1.25 mg) - 1.25 mg dose oral once daily for 90 days

Experimental: Finerenone (BAY94-8862)(2.5 mg) - 2.5 mg dose oral once daily for 90 days

Experimental: Finerenone (BAY94-8862)(5 mg) - 5 mg dose oral once daily for 90 days

Experimental: Finerenone (BAY94-8862)(7.5 mg) - 7.5 mg dose oral once daily for 90 days

Experimental: Finerenone (BAY94-8862) (10 mg) - 10 mg dose oral once daily for 90 days

Experimental: Finerenone (BAY94-8862) (15 mg) - 15 mg dose oral once daily for 90 days

Experimental: Finerenone (BAY94-8862)(20 mg) - 20 mg dose oral once daily for 90 days

Placebo Comparator: Placebo - Placebo oral dose once daily for 90 days


Treatment: Drugs: Finerenone (BAY94-8862)


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ratio of UACR at Day 90 to UACR at Baseline - 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.
Timepoint [1] 0 0
Baseline and Day 90±2
Secondary outcome [1] 0 0
Change From Baseline to Day 90 in Serum Potassium
Timepoint [1] 0 0
Baseline and Day 90±2
Secondary outcome [2] 0 0
Change From Baseline to Day 90 in eGFR - 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.
Timepoint [2] 0 0
Baseline and Day 90±2
Secondary outcome [3] 0 0
Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) - 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.
Timepoint [3] 0 0
Baseline and Day 90±2
Secondary outcome [4] 0 0
Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) - 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).
Timepoint [4] 0 0
Baseline and Day 90±2

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- St Leonards
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Prahran
Recruitment hospital [5] 0 0
- Reservoir
Recruitment hospital [6] 0 0
- Box Hill
Recruitment hospital [7] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3052 - Melbourne
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment postcode(s) [5] 0 0
3073 - Reservoir
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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California
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Connecticut
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Illinois
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United States of America
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Michigan
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United States of America
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New York
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Salzburg
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Austria
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St. Pölten
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Austria
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Wien
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Bulgaria
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Haskovo
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Lukovit
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Bulgaria
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Plovdiv
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Varna
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Koprivnice
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Czechia
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Krnov
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Czechia
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Aarhus C
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Gentofte
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Kolding
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Helsinki
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Jyväskylä
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Finland
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Oulu
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Tampere
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Western Cape
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Uppsala
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Örebro
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Taiwan
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Kaohsiung
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Taiwan
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Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01874431
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications