AzTrials
AzTrials

Diabetic NephropathiesPhase 2ARTS-DNNCT01874431

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

A Phase 2 study testing Finerenone (BAY94-8862) in people with Diabetic Nephropathies, run by Bayer at 147 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Nephropathies
What is being tested?
Finerenone (BAY94-8862)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
823 participants
Where
147 sitesin 23 countries
Study dates
12 Jun 2013to 7 Aug 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

147 sites in 23 countries.

147 sites in 23 countries

United States15 sites

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Chattanooga, Tennessee, 37408

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chula Vista, California, 91910

  • Study site

    Dallas, Texas, 75235-3858

  • Study site

    Flint, Michigan, 48504

  • Study site

    Flushing, New York, 11355

  • Study site

    Los Angeles, California, 90022

  • Study site

    Los Gatos, California, 95032

  • Study site

    Miami, Florida, 33015

  • Study site

    New Haven, Connecticut, 06510

  • Study site

    Orangeburg, South Carolina, 29118

  • Study site

    Pembroke Pines, Florida, 33028

Other trials in United States

South Africa13 sites

  • Study site

    Cape Town, Western Cape, 7570

  • Study site

    Durban, KwaZulu-Natal, 4037

  • Study site

    Durban, KwaZulu-Natal, 4067

  • Study site

    Durban, KwaZulu-Natal, 4091

  • Study site

    Goodwood, Western Cape, 7460

  • Study site

    Klipsruit West, Gauteng, 1812

  • Study site

    Krugersdorp, Gauteng, 1739

  • Study site

    Lenasia South, Gauteng, 1829

  • Study site

    Merebank, KwaZulu-Natal, 4052

  • Study site

    Newtown, Gauteng, 2113

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Tongaat, KwaZulu-Natal, 4400

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Italy10 sites

  • Study site

    Bergamo, Lombardy, 24020

  • Study site

    Bergamo, Lombardy, 24127

  • Study site

    Cagliari, Sardinia, 09134

  • Study site

    Foggia, Apulia, 71013

  • Study site

    Milan, Lombardy, 20134

  • Study site

    Milan, Lombardy, 20157

  • Study site

    Monza-Brianza, Lombardy, 20832

  • Study site

    Naples, Campania, 80131

  • Study site

    Padova, Veneto, 35128

  • Study site

    Pisa, Tuscany, 56124

Other trials in Italy

Sweden9 sites

  • Study site

    Karlstad, 651 85

  • Study site

    Kristianstad, 29185

  • Study site

    Örebro, 701 85

  • Study site

    Skövde, 541 85

  • Study site

    Stockholm, 111 57

  • Study site

    Stockholm, 113 24

  • Study site

    Stockholm, 141 86

  • Study site

    Uppsala, 753 19

  • Study site

    Vällingby, 162 68

Other trials in Sweden

Bulgaria8 sites

  • Study site

    Haskovo, 6300

  • Study site

    Lukovit, 5770

  • Study site

    Plovdiv, 4002

  • Study site

    Rousse, 7003

  • Study site

    Sofia, 1431

  • Study site

    Stara Zagora, 6000

  • Study site

    Varna, 9000

  • Study site

    Varna, 9010

Other trials in Bulgaria

Canada8 sites

  • Study site

    Courtice, Ontario, L1E 3C3

  • Study site

    Kitchener, Ontario, N2H 5Z8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Scarborough Village, Ontario, M1H 3G4

  • Study site

    Toronto, Ontario, M4C 5T2

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Vancouver, British Columbia, V5Z 1L8

  • Study site

    Vancouver, British Columbia, V6E 1M7

Other trials in Canada

Australia7 sites

  • Study site

    Box Hill, 3128

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Melbourne, Victoria, 3052

  • Study site

    Prahran, Victoria, 3181

  • Study site

    Reservoir, Victoria, 3073

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Woolloongabba, 4102

Other trials in Australia

Denmark7 sites

  • Study site

    Aarhus C, 8000

  • Study site

    Gentofte Municipality, 2820

  • Study site

    Herlev, 2730

  • Study site

    Hillerød, DK-3400

  • Study site

    Holbæk, 4300

  • Study site

    Holstebro, DK-7500

  • Study site

    Kolding, 6000

Other trials in Denmark

Israel7 sites

  • Study site

    Ashkelon, 7830604

  • Study site

    Holon, 5822012

  • Study site

    Jerusalem, 9112001

  • Study site

    Kfar Saba, 4428164

  • Study site

    Petah Tikva, 4941492

  • Study site

    Tel Aviv, 6203854

  • Study site

    Tel Aviv, 6937947

Other trials in Israel

Poland7 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-822

  • Study site

    Lodz, 90-153

  • Study site

    Lublin, 20-081

  • Study site

    Oława, 55-200

  • Study site

    Warsaw

  • Study site

    Wroclaw, 51-162

Other trials in Poland

Spain7 sites

  • Study site

    Barcelona, 08025

  • Study site

    Ferrol, A Coruña, 15405

  • Study site

    Girona, 17007

  • Study site

    Jerez de la Frontera, Cádiz, 11407

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28041

  • Study site

    Sagunto, Valencia, 46520

Other trials in Spain

Austria6 sites

  • Study site

    Graz, 3086

  • Study site

    Innsbruck, 6020

  • Study site

    Salzburg, 5020

  • Study site

    Salzburg, 5026

  • Study site

    Sankt Pölten, 3100

  • Study site

    Vienna, 1130

Other trials in Austria

Finland5 sites

  • Study site

    Helsinki, 00180

  • Study site

    Jyväskylä, 40620

  • Study site

    Oulu, 90100

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20520

Other trials in Finland

France5 sites

  • Study site

    Amiens, 80000

  • Study site

    La Tronche, 38700

  • Study site

    Lyon, 69437

  • Study site

    Paris, 75908

  • Study site

    Strasbourg, 67091

Other trials in France

Germany5 sites

  • Study site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40210

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • Study site

    Neuwied, Rhineland-Palatinate, 56564

Other trials in Germany

Hungary5 sites

  • Study site

    Budapest, 1085

  • Study site

    Debrecen, 4032

  • Study site

    Eger, 3300

  • Study site

    Nagykanizsa, 8800

  • Study site

    Pápa, 8500

Other trials in Hungary

Netherlands5 sites

  • Study site

    Almere Stad, 1311 RL

  • Study site

    Eindhoven, 5600 PD

  • Study site

    Groningen, 9713 GZ

  • Study site

    Hoogeveen, 7909 AA

  • Study site

    Maastricht, 6229 HX

Other trials in Netherlands

Czechia4 sites

  • Study site

    Chrudim, 537 01

  • Study site

    Kopřivnice, 742 21

  • Study site

    Krnov, 794 01

  • Study site

    Prague, 12808

Other trials in Czechia

Taiwan4 sites

  • Study site

    Kaohsiung City, 833

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 110

  • Study site

    Taipei, 11217

Other trials in Taiwan

Portugal3 sites

  • Study site

    Almada, 2801-951

  • Study site

    Lisbon, 1069-166

  • Study site

    Lisbon, 1449-005

Other trials in Portugal

South Korea3 sites

  • Study site

    Busan, 49241

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 06591

Other trials in South Korea

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Shatin

Other trials in Hong Kong

Norway2 sites

  • Study site

    Ålesund, 6026

  • Study site

    Hamar, 2326

Other trials in Norway

About this study

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

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.

Being tested
Finerenone (BAY94-8862), Placebo
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Finerenone (BAY94-8862)Drug

  • PlaceboDrug

Study groups in NCT01874431
Study groupRoleWhat they receive
Finerenone (BAY94-8862) (1.25 mg)Experimental1.25 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(2.5 mg)Experimental2.5 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(5 mg)Experimental5 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(7.5 mg)Experimental7.5 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862) (10 mg)Experimental10 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862) (15 mg)Experimental15 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(20 mg)Experimental20 mg dose oral once daily for 90 days
Receives: Drug: Finerenone (BAY94-8862)
PlaceboPlacebo comparatorPlacebo oral dose once daily for 90 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Day 90±2

Secondary outcomes (4)

  1. Change From Baseline to Day 90 in Serum Potassium

    Measured: Baseline and Day 90±2

  2. 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.

    Measured: Baseline and Day 90±2

  3. 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.

    Measured: Baseline and Day 90±2

  4. 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).

    Measured: Baseline and Day 90±2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2013 (estimated)
  2. Study start12 Jun 2013
  3. Primary completion9 Jul 2014
  4. Study completion7 Aug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01874431
Sponsor's protocol ID
16243
Other IDs
2012-004179-38
Acronym
ARTS-DN
Status last verified
Jun 2021
First submitted
7 Jun 2013
Last updated
1 Jul 2021
Data monitoring committee
Yes

Publications

  • Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

    PubMed 26325557

  • Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.

    PubMed 31583611

  • Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

    PubMed 33107592

  • Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2026 Feb 1;37(2):312-325. doi: 10.1681/ASN.0000000823. Epub 2025 Sep 12.

    PubMed 40938666

  • Li P, Cui Y, Xu X, Dong J, Liao L. Cardiorenal Benefits of Finerenone in Different Races and Kidney Function in Patients with Chronic Kidney Disease. Cardiorenal Med. 2024;14(1):227-234. doi: 10.1159/000538347. Epub 2024 Mar 27.

    PubMed 38537621

  • Agarwal R, Ruilope LM, Ruiz-Hurtado G, Haller H, Schmieder RE, Anker SD, Filippatos G, Pitt B, Rossing P, Lambelet M, Nowack C, Kolkhof P, Joseph A, Bakris GL. Effect of finerenone on ambulatory blood pressure in chronic kidney disease in type 2 diabetes. J Hypertens. 2023 Feb 1;41(2):295-302. doi: 10.1097/HJH.0000000000003330. Epub 2022 Dec 8.

    PubMed 36583355

  • Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.

    PubMed 33358451

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Finerenone (BAY94-8862) in people with Diabetic Nephropathies, run by Bayer at 147 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, South Africa, Italy, Sweden, Bulgaria and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of UACR at Day 90 to UACR at Baseline (time frame: Baseline and Day 90±2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01874431, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in