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

Type 2 Diabetes Mellitus Clinical Trial

— FIGARO-BM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05013008
• Other study ID #: 21952
• Secondary ID: 2021-003053-37
• Status: Completed
• Phase: Phase 2
• Start date: August 18, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 951
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

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
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.

Locations

Country	Name	City	State
Australia	Melbourne Renal Research Group	Reservoir	Victoria
Australia	Illawarra Diabetes Service	Wollongong	New South Wales
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Klinik Landstraße - Krankenhaus Rudolfstiftung	Wien
Austria	Zentrum f. klinische Studien Dr. Hanusch GmbH	Wien
Belgium	UZ Gent	Gent
Belgium	AZ Delta	Roeselaere
Bulgaria	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
Canada	Hopital Charles LeMoyne	Greenfield Park	Quebec
Canada	Manna Research (Mirabel)	Mirabel	Quebec
Canada	Fraser Clinical Trials, Inc.	New Westminster	British Columbia
Canada	Clinique des Maladies Lipidques de Quebec	Quebec
Czechia	Nefrologicka ambulance	Praha 4
Denmark	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
Finland	Terveystalo Oulu	Oulu
Finland	Lääkärikeskus Minerva	Rauma
Finland	Turun yliopistollinen keskussairaala	Turku
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital Hong Kong	Shatin
Hong Kong	Tung Wah Hospital	Sheung Wan
Israel	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
Italy	ASST Papa Giovanni XXIII	Bergamo	Lombardia
Italy	Istituto Ricerche Farmacologiche Mario Negri IRCCS	Bergamo	Lombardia
Italy	A.O.U. di Bologna Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna
Italy	ASST Santi Paolo e Carlo	Milano	Lombardia
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Shonan Fujisawa Tokushukai Hospital	Fujisawa	Kanagawa
Japan	Fukuoka University Hospital	Fukuoka
Japan	Higashihiroshima Medical Center	Higashihiroshima	Hiroshima
Japan	Kohnodai Hospital, NC for Global Health and Medicine	Ichikawa	Chiba
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Fukuoka Tokushukai Hospital	Kasuga	Fukuoka
Japan	Sugiura Clinic	Kawaguchi	Saitama
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Steel Memorial Yawata Hospital	Kitakyushu	Fukuoka
Japan	Komatsu Municipal Hospital	Komatsu	Ishikawa
Japan	Japanese Red Cross Kumamoto Hospital	Kumamoto
Japan	Saiseikai Matsuyama Hospital	Matsuyama	Ehime
Japan	Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	Nakakinen Clinic	Naka	Ibaraki
Japan	Jiyugaoka YAMADA Clinic	Obihiro	Hokkaido
Japan	Kitano Hospital	Osaka
Japan	Kyosokai AMC NISHI-UMEDA Clinic	Osaka
Japan	Association of healthcare corporation, Oyama East Clinic	Oyama	Tochigi
Japan	Shirakawa Kosei General Hospital	Shirakawa	Fukushima
Japan	Osaka Saiseikai Senri Hospital	Suita	Osaka
Japan	Noritake Clinic	Ushiku	Ibaraki
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Yonsei University Wonju Christian Hospital	Wonju	Gang''weondo
Netherlands	Albert Schweitzer Ziekenhuis, locatie Zwijndrecht	Zwijndrecht
Portugal	Centro Clinico Academico - Braga	Braga
Russian Federation	First City Clinical Hospital n.a. E.E. Volosevich	Arkhangelsk
Russian Federation	Izhevsk City Clinical Hospital #9	Izhevsk
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo
Russian Federation	Sci-Res. Institute of Complex Cardiovascular Disorders	Kemerovo
Russian Federation	Center of cardiology and neurology	Kirov
Russian Federation	Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky	Krasnodar
Russian Federation	Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov	Moscow
Russian Federation	Moscow State University n.a. M.V. Lomonosov	Moscow
Russian Federation	PHI "Central Clinical Hospital "RZD-Medicine"	Moscow
Russian Federation	City Clinical Hospital #13 Nizhny Novgorod	Nizhny Novgorod
Russian Federation	Saratov City Clinical Hospital #9	Saratov
Russian Federation	City Outpatient Clinic #4	Voronezh
Russian Federation	Voronezh Regional Clinical Consultancy-Diagnostic Center	Voronezh
Russian Federation	Clinical Hospital for Emergency Care n.a. N.V.Solovyov	Yaroslavl
Singapore	National Heart Centre Singapore	Singapore
Singapore	Singapore General Hospital	Singapore
Spain	Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition	A Coruna	A Coruña
Spain	Hospital del Mar | Nephrology Department	Barcelona
Spain	Hospital SAS de Jerez de la Frontera	Jerez de la Frontera	Cádiz
Spain	Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial	Lugar Da Pega	A Coruña
Spain	Hospital Universitario 12 de Octubre	Madrid
Sweden	PTC-Primary care Trial Center	Göteborg
Sweden	Avdelningen för kliniska prövningar AKP	Örebro
Sweden	ClinSmart	Uppsala
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung
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
United States	Randolph Medical Associates	Asheboro	North Carolina
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Florida Kidney Physicians - Fort Lauderdale	Fort Lauderdale	Florida
United States	Indago Research & Health Center, Inc.	Hialeah	Florida
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Crescent City Clinical Research Center, LLC	Metairie	Louisiana
United States	Floridian Clinical Research, LLC	Miami Lakes	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	Valley Clinical Trials, Inc. - Northridge	Northridge	California
United States	Saviers Medical Group	Port Hueneme	California
United States	Clinical Advancement Center, PLLC	San Antonio	Texas
United States	Chase Medical Research, LLC	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  Denmark,  Finland,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Portugal,  Russian Federation,  Singapore,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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