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 (FIGARO-BM)

A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Drug: Finerenone (Kerendia, BAY94-8862); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 951
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia, 2500
      • Illawarra Diabetes Service
  • Victoria
    • Reservoir, Victoria, Australia, 3073
      • Melbourne Renal Research Group
• Austria
  • Wien, Austria, 1030
    • Klinik Landstraße - Krankenhaus Rudolfstiftung
  • Wien, Austria, 1060
    • Zentrum f. klinische Studien Dr. Hanusch GmbH
  • Steiermark
    • Graz, Steiermark, Austria, 8036
      • Medizinische Universität Graz
• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
  • Roeselaere, Belgium, 8800
    • AZ Delta
• Bulgaria
  • Gorna Oryahovitsa, Bulgaria, 5100
    • Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
  • Plovdiv, Bulgaria, 4002
    • DCC 2 - Plovdiv EOOD
  • Yambol, Bulgaria, 8600
    • MHAT Sveti Pantaleymon - Yambol
• Canada
  • Quebec, Canada, G1V 4W1
    • Clinique des Maladies Lipidques de Quebec
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials, Inc.
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles LeMoyne
    • Mirabel, Quebec, Canada, J7J 2K8
      • Manna Research (Mirabel)
• Czechia
  • Praha 4, Czechia, 140 00
    • Nefrologicka ambulance
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital, Skejby
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Sygehus Esbjerg, Endocrinology dept.
  • Hellerup, Denmark, 2900
    • Capital Region | Gentofte Hospital - Cardiology Research
  • Herlev, Denmark, 2730
    • Steno Diabetes Center Copenhagen
  • Herlev, Denmark, 2730
    • Herlev Hospital - Endocrinology dept.
  • Holbæk, Denmark, 4300
    • Holbæk Sygehus
  • Holstebro, Denmark, DK-7500
    • Holstebro Hospital, Endocrinology dept.
  • København NV, Denmark, 2400
    • Bispebjerg Hospital
  • Viborg, Denmark, 8800
    • Viborg Sygehus
• Finland
  • Oulu, Finland, 90100
    • Terveystalo Oulu
  • Rauma, Finland, 26100
    • Lääkärikeskus Minerva
  • Turku, Finland, 20520
    • Turun yliopistollinen keskussairaala
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Shatin, Hong Kong
    • Prince of Wales Hospital Hong Kong
  • Sheung Wan, Hong Kong
    • Tung Wah Hospital
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center | Nephrology & Hypertension Dept.
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Hebrew University Hospital Ein Kerem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Nazareth, Israel, 16100
    • The Nazareth Trust Hospital EMMS
  • Tel Aviv, Israel, 6203854
    • Clalit Health Services, Midgal Hamea
  • Tel Aviv, Israel, 6937947
    • DMC - Diabetes Medical Center
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • Lombardia
    • Bergamo, Lombardia, Italy, 24127
      • Asst Papa Giovanni XXIII
    • Bergamo, Lombardia, Italy, 24020
      • Istituto Ricerche Farmacologiche Mario Negri IRCCS
    • Milano, Lombardia, Italy, 20142
      • ASST Santi Paolo e Carlo
• Japan
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Kumamoto, Japan, 861-8520
    • Japanese Red Cross Kumamoto Hospital
  • Nagasaki, Japan, 852-8511
    • Japanese Red Cross Nagasaki Genbaku Hospital
  • Osaka, Japan, 530-8480
    • Kitano Hospital
  • Osaka, Japan, 530-0001
    • Kyosokai Amc Nishi-Umeda Clinic
  • Chiba
    • Ichikawa, Chiba, Japan, 272-8516
      • Kohnodai Hospital, NC for Global Health and Medicine
  • Ehime
    • Matsuyama, Ehime, Japan, 791-8026
      • Saiseikai Matsuyama Hospital
  • Fukuoka
    • Chikushino, Fukuoka, Japan, 818-8502
      • Fukuoka University Chikushi Hospital
    • Kasuga, Fukuoka, Japan, 816-0864
      • Fukuoka Tokushukai Hospital
    • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kokura Memorial Hospital
    • Kitakyushu, Fukuoka, Japan, 805-8508
      • Steel Memorial Yawata Hospital
  • Fukushima
    • Shirakawa, Fukushima, Japan, 961-0005
      • Shirakawa Kosei General Hospital
  • Hiroshima
    • Higashihiroshima, Hiroshima, Japan, 739-0041
      • Higashihiroshima Medical Center
  • Hokkaido
    • Obihiro, Hokkaido, Japan, 080-0848
      • Jiyugaoka Yamada Clinic
  • Ibaraki
    • Naka, Ibaraki, Japan, 311-0113
      • Nakakinen clinic
    • Ushiku, Ibaraki, Japan, 300-1207
      • Noritake Clinic
  • Ishikawa
    • Komatsu, Ishikawa, Japan, 923-8560
      • Komatsu Municipal Hospital
  • Kanagawa
    • Fujisawa, Kanagawa, Japan, 251-0041
      • Shonan Fujisawa Tokushukai Hospital
    • Kamakura, Kanagawa, Japan, 247-8533
      • Shonan Kamakura General Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0862
      • Osaka Saiseikai Senri Hospital
  • Saitama
    • Kawaguchi, Saitama, Japan, 332-0012
      • Sugiura Clinic
  • Tochigi
    • Oyama, Tochigi, Japan, 323-0022
      • Association of healthcare corporation, Oyama East Clinic
• Korea, Republic of
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 3722
    • Severance Hospital, Yonsei University Health System
  • Gang''weondo
    • Wonju, Gang''weondo, Korea, Republic of, 26426
      • Yonsei University Wonju Christian Hospital
  • Gyeonggido
    • Anyang-si, Gyeonggido, Korea, Republic of, 14068
      • Hallym University Sacred Heart Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Seoul National University Hospital
• Netherlands
  • Zwijndrecht, Netherlands, 3331 LZ
    • Albert Schweitzer Ziekenhuis, locatie Zwijndrecht
• Portugal
  • Braga, Portugal, 4710-243
    • Centro Clinico Academico - Braga
• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • First City Clinical Hospital n.a. E.E. Volosevich
  • Izhevsk, Russian Federation, 426063
    • Izhevsk City Clinical Hospital #9
  • Kemerovo, Russian Federation, 650066
    • Kemerovo Regional Clinical Hospital
  • Kemerovo, Russian Federation, 650002
    • Sci-Res. Institute of Complex Cardiovascular Disorders
  • Kirov, Russian Federation, 610014
    • Center of Cardiology and Neurology
  • Krasnodar, Russian Federation, 350086
    • Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
  • Moscow, Russian Federation, 119192
    • Moscow State University n.a. M.V. Lomonosov
  • Moscow, Russian Federation, 123182
    • Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov
  • Moscow, Russian Federation, 125315
    • PHI "Central Clinical Hospital "RZD-Medicine"
  • Nizhny Novgorod, Russian Federation, 603018
    • City Clinical Hospital #13 Nizhny Novgorod
  • Saratov, Russian Federation, 410030
    • Saratov City Clinical Hospital #9
  • Voronezh, Russian Federation, 394018
    • Voronezh Regional Clinical Consultancy-Diagnostic Center
  • Voronezh, Russian Federation, 394077
    • City Outpatient Clinic #4
  • Yaroslavl, Russian Federation, 150003
    • Clinical Hospital for Emergency Care n.a. N.V.Solovyov
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar | Nephrology Department
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • A Coruña
    • A Coruna, A Coruña, Spain, 15006
      • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
    • Lugar Da Pega, A Coruña, Spain, 15405
      • Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
      • Hospital SAS de Jerez de la Frontera
• Sweden
  • Göteborg, Sweden, 413 46
    • PTC-Primary care Trial Center
  • Uppsala, Sweden, 752 37
    • ClinSmart
  • Örebro, Sweden, 703 62
    • Avdelningen för kliniska prövningar AKP
• Taiwan
  • Changhua, Taiwan, 50006
    • Changhua Christian Hospital
  • Kaohsiung, Taiwan, 833
    • Chang Gung Memorial Hospital Kaohsiung
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital | Nephrology Department
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
• United States
  • California
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc. - Northridge
    • Port Hueneme, California, United States, 93041
      • Saviers Medical Group
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Kidney Physicians - Fort Lauderdale
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Miami Lakes, Florida, United States, 33016
      • Floridian Clinical Research, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Crescent City Clinical Research Center, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Medical Center
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Randolph Medical Associates
  • Texas
    • San Antonio, Texas, United States, 78212-4740
      • Clinical Advancement Center, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 21952; 2021-003053-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No