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

NCT ID: NCT05013008

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 951 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-18
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Finerenone

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.

Group Type: EXPERIMENTAL

Finerenone (Kerendia, BAY94-8862)

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Finerenone (Kerendia, BAY94-8862)

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Valley Clinical Trials, Inc. - Northridge

Northridge, California, United States

Saviers Medical Group

Port Hueneme, California, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Florida Kidney Physicians - Fort Lauderdale

Fort Lauderdale, Florida, United States

Indago Research & Health Center, Inc.

Hialeah, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Crescent City Clinical Research Center, LLC

Metairie, Louisiana, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

Randolph Medical Associates

Asheboro, North Carolina, United States

Clinical Advancement Center, PLLC

San Antonio, Texas, United States

Illawarra Diabetes Service

Wollongong, New South Wales, Australia

Melbourne Renal Research Group

Reservoir, Victoria, Australia

Medizinische Universität Graz

Graz, Styria, Austria

Klinik Landstraße - Krankenhaus Rudolfstiftung

Vienna, , Austria

Zentrum f. klinische Studien Dr. Hanusch GmbH

Vienna, , Austria

UZ Gent

Ghent, , Belgium

AZ Delta

Roeselaere, , Belgium

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

Gorna Oryahovitsa, , Bulgaria

DCC 2 - Plovdiv EOOD

Plovdiv, , Bulgaria

MHAT Sveti Pantaleymon - Yambol

Yambol, , Bulgaria

Fraser Clinical Trials, Inc.

New Westminster, British Columbia, Canada

Hopital Charles LeMoyne

Greenfield Park, Quebec, Canada

Manna Research (Mirabel)

Mirabel, Quebec, Canada

Clinique des Maladies Lipidques de Quebec

Québec, , Canada

Nefrologicka ambulance

Prague, , Czechia

Aarhus Universitetshospital, Skejby

Aarhus N, , Denmark

Sydvestjysk Sygehus Esbjerg, Endocrinology dept.

Esbjerg, , Denmark

Capital Region | Gentofte Hospital - Cardiology Research

Hellerup, , Denmark

Herlev Hospital - Endocrinology dept.

Herlev, , Denmark

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Holbæk Sygehus

Holbæk, , Denmark

Holstebro Hospital, Endocrinology dept.

Holstebro, , Denmark

Bispebjerg Hospital

København NV, , Denmark

Viborg Sygehus

Viborg, , Denmark

Terveystalo Oulu

Oulu, , Finland

Lääkärikeskus Minerva

Rauma, , Finland

Turun yliopistollinen keskussairaala

Turku, , Finland

Queen Mary Hospital

Hong Kong, , Hong Kong

Prince of Wales Hospital Hong Kong

Shatin, , Hong Kong

Tung Wah Hospital

Sheung Wan, , Hong Kong

Barzilai Medical Center | Nephrology & Hypertension Dept.

Ashkelon, , Israel

Edith Wolfson Medical Center

Holon, , Israel

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

The Nazareth Trust Hospital EMMS

Nazareth, , Israel

Clalit Health Services, Midgal Hamea

Tel Aviv, , Israel

DMC - Diabetes Medical Center

Tel Aviv, , Israel

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

Bologna, Emilia-Romagna, Italy

Istituto Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, Lombardy, Italy

ASST Papa Giovanni XXIII

Bergamo, Lombardy, Italy

ASST Santi Paolo e Carlo

Milan, Lombardy, Italy

Kohnodai Hospital, NC for Global Health and Medicine

Ichikawa, Chiba, Japan

Saiseikai Matsuyama Hospital

Matsuyama, Ehime, Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Fukuoka Tokushukai Hospital

Kasuga, Fukuoka, Japan

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Steel Memorial Yawata Hospital

Kitakyushu, Fukuoka, Japan

Shirakawa Kosei General Hospital

Shirakawa, Fukushima, Japan

Higashihiroshima Medical Center

Higashihiroshima, Hiroshima, Japan

Jiyugaoka YAMADA Clinic

Obihiro, Hokkaido, Japan

Nakakinen Clinic

Naka, Ibaraki, Japan

Noritake Clinic

Ushiku, Ibaraki, Japan

Komatsu Municipal Hospital

Komatsu, Ishikawa-ken, Japan

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Osaka Saiseikai Senri Hospital

Suita, Osaka, Japan

Sugiura Clinic

Kawaguchi, Saitama, Japan

Association of healthcare corporation, Oyama East Clinic

Oyama, Tochigi, Japan

Fukuoka University Hospital

Fukuoka, , Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, , Japan

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, , Japan

Kyosokai AMC NISHI-UMEDA Clinic

Osaka, , Japan

Kitano Hospital

Osaka, , Japan

Albert Schweitzer Ziekenhuis, locatie Zwijndrecht

Zwijndrecht, , Netherlands

Centro Clinico Academico - Braga

Braga, , Portugal

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

Arkhangelsk, , Russia

Izhevsk City Clinical Hospital #9

Izhevsk, , Russia

Sci-Res. Institute of Complex Cardiovascular Disorders

Kemerovo, , Russia

Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

Center of cardiology and neurology

Kirov, , Russia

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

Krasnodar, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

PHI "Central Clinical Hospital "RZD-Medicine"

Moscow, , Russia

City Clinical Hospital #13 Nizhny Novgorod

Nizhny Novgorod, , Russia

Saratov City Clinical Hospital #9

Saratov, , Russia

Voronezh Regional Clinical Consultancy-Diagnostic Center

Voronezh, , Russia

City Outpatient Clinic #4

Voronezh, , Russia

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

Yaroslavl, , Russia

Singapore General Hospital

Singapore, , Singapore

National Heart Centre Singapore

Singapore, , Singapore

Yonsei University Wonju Christian Hospital

Wŏnju, Gang''weondo, South Korea

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggido, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Korea University Anam Hospital

Seoul, , South Korea

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

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

A Coruña, A Coruña, Spain

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

Lugar Da Pega, A Coruña, Spain

Hospital SAS de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Hospital del Mar | Nephrology Department

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

PTC-Primary care Trial Center

Gothenburg, , Sweden

Avdelningen för kliniska prövningar AKP

Örebro, , Sweden

ClinSmart

Uppsala, , Sweden

Changhua Christian Hospital

Changhua, , Taiwan

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, , Taiwan

Far Eastern Memorial Hospital | Nephrology Department

New Taipei City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

United States; Australia; Austria; Belgium; Bulgaria; Canada; Czechia; Denmark; Finland; Hong Kong; Israel; Italy; Japan; Netherlands; Portugal; Russia; Singapore; South Korea; Spain; Sweden; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.bayer.com/study/21952

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2021-003053-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21952

Identifier Type: -

Identifier Source: org_study_id