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)

June 30, 2021 updated by: Bayer

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 was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

823

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Australia, 3128
      • Woolloongabba, Australia, 4102
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Melbourne, Victoria, Australia, 3052
      • Prahran, Victoria, Australia, 3181
      • Reservoir, Victoria, Australia, 3073
  • Austria
      • Graz, Austria, 3086
      • Innsbruck, Austria, 6020
      • Salzburg, Austria, 5020
      • Salzburg, Austria, 5026
      • St. Pölten, Austria, 3100
      • Wien, Austria, 1130
  • Bulgaria
      • Haskovo, Bulgaria, 6300
      • Lukovit, Bulgaria, 5770
      • Plovdiv, Bulgaria, 4002
      • Ruse, Bulgaria, 7003
      • Sofia, Bulgaria, 1431
      • Stara Zagora, Bulgaria, 6000
      • Varna, Bulgaria, 9010
      • Varna, Bulgaria, 9000
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
      • Vancouver, British Columbia, Canada, V6E 1M7
    • Ontario
      • Courtice, Ontario, Canada, L1E 3C3
      • Kitchener, Ontario, Canada, N2H 5Z8
      • Scarborough, Ontario, Canada, M1H 3G4
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M4C 5T2
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
  • Czechia
      • Chrudim, Czechia, 537 01
      • Koprivnice, Czechia, 742 21
      • Krnov, Czechia, 794 01
      • Praha 2, Czechia, 12808
  • Denmark
      • Aarhus C, Denmark, 8000
      • Gentofte, Denmark, 2820
      • Herlev, Denmark, 2730
      • Hillerød, Denmark, DK-3400
      • Holbaek, Denmark, 4300
      • Holstebro, Denmark, DK-7500
      • Kolding, Denmark, 6000
  • Finland
      • Helsinki, Finland, 00180
      • Jyväskylä, Finland, 40620
      • Oulu, Finland, 90100
      • Tampere, Finland, 33520
      • Turku, Finland, 20520
  • France
      • Amiens, France, 80000
      • La Tronche, France, 38700
      • Lyon Cedex, France, 69437
      • Paris Cedex 15, France, 75908
      • Strasbourg, France, 67091
  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40210
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67059
      • Neuwied, Rheinland-Pfalz, Germany, 56564
  • Hong Kong
      • Hong Kong, Hong Kong
      • Shatin, Hong Kong
  • Hungary
      • Budapest, Hungary, 1085
      • Debrecen, Hungary, 4032
      • Eger, Hungary, 3300
      • Nagykanizsa, Hungary, 8800
      • Papa, Hungary, 8500
  • Israel
      • Ashkelon, Israel, 7830604
      • Holon, Israel, 5822012
      • Jerusalem, Israel, 9112001
      • Kfar Saba, Israel, 4428164
      • Petach Tikva, Israel, 4941492
      • Tel Aviv, Israel, 6203854
      • Tel Aviv, Israel, 6937947
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
      • Bergamo, Lombardia, Italy, 24020
      • Milano, Lombardia, Italy, 20157
      • Milano, Lombardia, Italy, 20134
      • Monza-Brianza, Lombardia, Italy, 20832
    • Puglia
      • Foggia, Puglia, Italy, 71013
    • Sardegna
      • Cagliari, Sardegna, Italy, 09134
    • Toscana
      • Pisa, Toscana, Italy, 56124
    • Veneto
      • Padova, Veneto, Italy, 35128
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
      • Seoul, Korea, Republic of, 03722
      • Seoul, Korea, Republic of, 06591
  • Netherlands
      • AlMERE, Netherlands, 1311 RL
      • Eindhoven, Netherlands, 5600 PD
      • Groningen, Netherlands, 9713 GZ
      • Hoogeveen, Netherlands, 7909 AA
      • Maastricht, Netherlands, 6229 HX
  • Norway
      • Hamar, Norway, 2326
      • Ålesund, Norway, 6026
  • Poland
      • Bialystok, Poland, 15-276
      • Bydgoszcz, Poland, 85-822
      • Lodz, Poland, 90-153
      • Lublin, Poland, 20-081
      • Olawa, Poland, 55-200
      • Warszawa, Poland
      • Wroclaw, Poland, 51-162
  • Portugal
      • Almada, Portugal, 2801-951
      • Lisboa, Portugal, 1069-166
      • Lisboa, Portugal, 1449-005
  • South Africa
    • Gauteng
      • Klipsruit West, Gauteng, South Africa, 1812
      • Krugersdorp, Gauteng, South Africa, 1739
      • Lenasia South, Gauteng, South Africa, 1829
      • Newtown, Gauteng, South Africa, 2113
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4091
      • Durban, KwaZulu Natal, South Africa, 4037
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4067
      • Merebank, Kwazulu-Natal, South Africa, 4052
      • Tongaat, Kwazulu-Natal, South Africa, 4400
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
      • Goodwood, Western Cape, South Africa, 7460
      • Somerset West, Western Cape, South Africa, 7130
      • Worcester, Western Cape, South Africa, 6850
  • Spain
      • Barcelona, Spain, 08025
      • Girona, Spain, 17007
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
    • A Coruña
      • Ferrol, A Coruña, Spain, 15405
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
    • Valencia
      • Sagunto, Valencia, Spain, 46520
  • Sweden
      • Karlstad, Sweden, 651 85
      • Kristianstad, Sweden, 29185
      • Skövde, Sweden, 541 85
      • Stockholm, Sweden, 141 86
      • Stockholm, Sweden, 113 24
      • Stockholm, Sweden, 111 57
      • Uppsala, Sweden, 753 19
      • Vällingby, Sweden, 162 68
      • Örebro, Sweden, 701 85
  • Taiwan
      • Kaohsiung, Taiwan, 833
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 110
      • Taipei, Taiwan, 10002
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Chula Vista, California, United States, 91910
      • Los Angeles, California, United States, 90022
      • Los Gatos, California, United States, 95032
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • Florida
      • Miami, Florida, United States, 33015
      • Pembroke Pines, Florida, United States, 33028
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
    • Michigan
      • Flint, Michigan, United States, 48504
    • New York
      • Flushing, New York, United States, 11355
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
    • Texas
      • Dallas, Texas, United States, 75235-3858
    • Vermont
      • Burlington, Vermont, United States, 05401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 90±2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Day 90 in Serum Potassium
Time Frame: Baseline and Day 90±2
Baseline and Day 90±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.
Baseline and Day 90±2
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.
Baseline and Day 90±2
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).
Baseline and Day 90±2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2013

Primary Completion (ACTUAL)

July 9, 2014

Study Completion (ACTUAL)

August 7, 2014

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (ESTIMATE)

June 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16243
  • 2012-004179-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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