Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ratio of UACR at Day 90 to UACR at Baseline
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
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)
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)
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
Sex
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
12/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/08/2014
Sample size
Target
Accrual to date
Final
823
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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California
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Connecticut
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Illinois
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Michigan
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New York
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South Carolina
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Tennessee
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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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Plovdiv
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Ruse
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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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British Columbia
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Ontario
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Oulu
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT01874431