An add-on Study to the FIGARO-DKD Study Called FIGARO-BM to Learn About the Link Between Biomarkers (Substances in the Blood Used as Indicators of Biological Processes, Disease Processes or Responses to Medication) and Finerenone in FIGARO-DKD Participants

NCT05013008 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 219522021-003053-37
• Study Type: interventional
• Target: 951
• Locations: 20 countries
• Sites: 112

Brief Summary

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD). FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required. Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney. In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion. The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.

Conditions

Chronic Kidney Disease; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers

  The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2\^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration.

  At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment

Study Arms (2)

Finerenone

EXPERIMENTAL

Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

Drug: Finerenone (Kerendia, BAY94-8862)

Placebo

PLACEBO COMPARATOR

Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study.

Drug: Placebo

Interventions

Finerenone (Kerendia, BAY94-8862) DRUG

Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.

Finerenone

Placebo DRUG

Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for ≥24 months.
• For each participant, pharmacokinetic (PK) plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD.

You may not qualify if:

• Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
• Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
• Participants with known fatal outcome.
• Participants with baseline estimated glomerular filtration rate (eGFR) ≤25 mL/min/1.73m\^2.
• Participants with low baseline risk (normal albuminuria and eGFR≥60 mL/min/1.73m\^2).
• Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation.

Sponsors & Collaborators

• Bayer: lead

Study Sites (115)

Valley Clinical Trials, Inc. - Northridge

Northridge, California, 91325, United States

Location

Saviers Medical Group

Port Hueneme, California, 93041, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Florida Kidney Physicians - Fort Lauderdale

Fort Lauderdale, Florida, 33308, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Crescent City Clinical Research Center, LLC

Metairie, Louisiana, 70006, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Randolph Medical Associates

Asheboro, North Carolina, 27203, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212-4740, United States

Location

Illawarra Diabetes Service

Wollongong, New South Wales, 2500, Australia

Location

Melbourne Renal Research Group

Reservoir, Victoria, 3073, Australia

Location

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Klinik Landstraße - Krankenhaus Rudolfstiftung

Vienna, 1030, Austria

Location

Zentrum f. klinische Studien Dr. Hanusch GmbH

Vienna, 1060, Austria

Location

UZ Gent

Ghent, 9000, Belgium

Location

AZ Delta

Roeselaere, 8800, Belgium

Location

Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department

Gorna Oryahovitsa, 5100, Bulgaria

Location

DCC 2 - Plovdiv EOOD

Plovdiv, 4002, Bulgaria

Location

MHAT Sveti Pantaleymon - Yambol

Yambol, 8600, Bulgaria

Location

Fraser Clinical Trials, Inc.

New Westminster, British Columbia, V3L 3W4, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Manna Research (Mirabel)

Mirabel, Quebec, J7J 2K8, Canada

Location

Clinique des Maladies Lipidques de Quebec

Québec, G1V 4W1, Canada

Location

Nefrologicka ambulance

Prague, 140 00, Czechia

Location

Aarhus Universitetshospital, Skejby

Aarhus N, 8200, Denmark

Location

Sydvestjysk Sygehus Esbjerg, Endocrinology dept.

Esbjerg, 6700, Denmark

Location

Capital Region | Gentofte Hospital - Cardiology Research

Hellerup, 2900, Denmark

Location

Herlev Hospital - Endocrinology dept.

Herlev, 2730, Denmark

Location

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Holstebro Hospital, Endocrinology dept.

Holstebro, DK-7500, Denmark

Location

Bispebjerg Hospital

København NV, 2400, Denmark

Location

Viborg Sygehus

Viborg, 8800, Denmark

Location

Terveystalo Oulu

Oulu, 90100, Finland

Location

Lääkärikeskus Minerva

Rauma, 26100, Finland

Location

Turun yliopistollinen keskussairaala

Turku, 20520, Finland

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital Hong Kong

Shatin, Hong Kong

Location

Tung Wah Hospital

Sheung Wan, Hong Kong

Location

Barzilai Medical Center | Nephrology & Hypertension Dept.

Ashkelon, 7830604, Israel

Location

Edith Wolfson Medical Center

Holon, 5822012, Israel

Location

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

The Nazareth Trust Hospital EMMS

Nazareth, 16100, Israel

Location

Clalit Health Services, Midgal Hamea

Tel Aviv, 6203854, Israel

Location

DMC - Diabetes Medical Center

Tel Aviv, 6937947, Israel

Location

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Istituto Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, Lombardy, 24020, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

ASST Santi Paolo e Carlo

Milan, Lombardy, 20142, Italy

Location

Kohnodai Hospital, NC for Global Health and Medicine

Ichikawa, Chiba, 272-8516, Japan

Location

Saiseikai Matsuyama Hospital

Matsuyama, Ehime, 791-8026, Japan

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, 816-0864, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Steel Memorial Yawata Hospital

Kitakyushu, Fukuoka, 805-8508, Japan

Location

Shirakawa Kosei General Hospital

Shirakawa, Fukushima, 961-0005, Japan

Location

Higashihiroshima Medical Center

Higashihiroshima, Hiroshima, 739-0041, Japan

Location

Jiyugaoka YAMADA Clinic

Obihiro, Hokkaido, 080-0848, Japan

Location

Nakakinen Clinic

Naka, Ibaraki, 311-0113, Japan

Location

Noritake Clinic

Ushiku, Ibaraki, 300-1207, Japan

Location

Komatsu Municipal Hospital

Komatsu, Ishikawa-ken, 923-8560, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, 251-0041, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan

Location

Osaka Saiseikai Senri Hospital

Suita, Osaka, 565-0862, Japan

Location

Sugiura Clinic

Kawaguchi, Saitama, 332-0012, Japan

Location

Association of healthcare corporation, Oyama East Clinic

Oyama, Tochigi, 323-0022, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

Location

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, 852-8511, Japan

Location

Kyosokai AMC NISHI-UMEDA Clinic

Osaka, 530-0001, Japan

Location

Kitano Hospital

Osaka, 530-8480, Japan

Location

Albert Schweitzer Ziekenhuis, locatie Zwijndrecht

Zwijndrecht, 3331 LZ, Netherlands

Location

Centro Clinico Academico - Braga

Braga, 4710-243, Portugal

Location

First City Clinical Hospital n.a. E.E. Volosevich

Arkhangelsk, 163001, Russia

Location

Izhevsk City Clinical Hospital #9

Izhevsk, 426063, Russia

Location

Sci-Res. Institute of Complex Cardiovascular Disorders

Kemerovo, 650002, Russia

Location

Kemerovo Regional Clinical Hospital

Kemerovo, 650066, Russia

Location

Center of cardiology and neurology

Kirov, 610014, Russia

Location

Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

Krasnodar, 350086, Russia

Location

Moscow State University n.a. M.V. Lomonosov

Moscow, 119192, Russia

Location

Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov

Moscow, 123182, Russia

Location

PHI "Central Clinical Hospital "RZD-Medicine"

Moscow, 125315, Russia

Location

City Clinical Hospital #13 Nizhny Novgorod

Nizhny Novgorod, 603018, Russia

Location

Saratov City Clinical Hospital #9

Saratov, 410030, Russia

Location

Voronezh Regional Clinical Consultancy-Diagnostic Center

Voronezh, 394018, Russia

Location

City Outpatient Clinic #4

Voronezh, 394077, Russia

Location

Clinical Hospital for Emergency Care n.a. N.V.Solovyov

Yaroslavl, 150003, Russia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Yonsei University Wonju Christian Hospital

Wŏnju, Gang''weondo, 26426, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggido, 14068, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 3722, South Korea

Location

Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition

A Coruña, A Coruña, 15006, Spain

Location

Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial

Lugar Da Pega, A Coruña, 15405, Spain

Location

Hospital SAS de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital del Mar | Nephrology Department

Barcelona, 08003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

PTC-Primary care Trial Center

Gothenburg, 413 46, Sweden

Location

Avdelningen för kliniska prövningar AKP

Örebro, 703 62, Sweden

Location

ClinSmart

Uppsala, 752 37, Sweden

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, 833, Taiwan

Location

Far Eastern Memorial Hospital | Nephrology Department

New Taipei City, 220, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

finerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This study was a retrospective, add-on study to the multi-center, interventional Phase 3 study FIGARO-DKD (NCT02545049). Blood plasma samples that were originally collected for PK analysis during the conduct of FIGARO-DKD study. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 19, 2021
• Study Start: August 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 15, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IT (4); KR (7); US (13); AU (2); BE (2); DK (9); IL (7); CA (4); CZ (1); PT (1); RU (14); SG (2); TW (6); HK (3); BU (3); SE (3); JP (22); FI (3); ES (5)