Clinical trial NCT05013008: 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
Official title: A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Type 2 Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers
timeFrame: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc. - Northridge
state: California
city: Port Hueneme
country: United States
facility: Saviers Medical Group
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Florida Kidney Physicians - Fort Lauderdale
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Metairie
country: United States
facility: Crescent City Clinical Research Center, LLC
state: Louisiana
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Asheboro
country: United States
facility: Randolph Medical Associates
state: North Carolina
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: Wollongong
country: Australia
facility: Illawarra Diabetes Service
state: New South Wales
city: Reservoir
country: Australia
facility: Melbourne Renal Research Group
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Wien
country: Austria
facility: Klinik Landstraße - Krankenhaus Rudolfstiftung
city: Wien
country: Austria
facility: Zentrum f. klinische Studien Dr. Hanusch GmbH
city: Gent
country: Belgium
facility: UZ Gent
city: Roeselaere
country: Belgium
facility: AZ Delta
city: Gorna Oryahovitsa
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
city: Plovdiv
country: Bulgaria
facility: DCC 2 - Plovdiv EOOD
city: Yambol
country: Bulgaria
facility: MHAT Sveti Pantaleymon - Yambol
city: New Westminster
country: Canada
facility: Fraser Clinical Trials, Inc.
state: British Columbia
city: Greenfield Park
country: Canada
facility: Hopital Charles LeMoyne
state: Quebec
city: Mirabel
country: Canada
facility: Manna Research (Mirabel)
state: Quebec
city: Quebec
country: Canada
facility: Clinique des Maladies Lipidques de Quebec
city: Praha 4
country: Czechia
facility: Nefrologicka ambulance
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Skejby
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus Esbjerg, Endocrinology dept.
city: Hellerup
country: Denmark
facility: Capital Region | Gentofte Hospital - Cardiology Research
city: Herlev
country: Denmark
facility: Herlev Hospital - Endocrinology dept.
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Holstebro
country: Denmark
facility: Holstebro Hospital, Endocrinology dept.
city: København NV
country: Denmark
facility: Bispebjerg Hospital
city: Viborg
country: Denmark
facility: Viborg Sygehus
city: Oulu
country: Finland
facility: Terveystalo Oulu
city: Rauma
country: Finland
facility: Lääkärikeskus Minerva
city: Turku
country: Finland
facility: Turun yliopistollinen keskussairaala
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital Hong Kong
city: Sheung Wan
country: Hong Kong
facility: Tung Wah Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center | Nephrology & Hypertension Dept.
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Hospital Ein Kerem
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Nazareth
country: Israel
facility: The Nazareth Trust Hospital EMMS
city: Tel Aviv
country: Israel
facility: Clalit Health Services, Midgal Hamea
city: Tel Aviv
country: Israel
facility: DMC - Diabetes Medical Center
city: Bologna
country: Italy
facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi
state: Emilia-Romagna
city: Bergamo
country: Italy
facility: Istituto Ricerche Farmacologiche Mario Negri IRCCS
state: Lombardia
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
state: Lombardia
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
state: Lombardia
city: Ichikawa
country: Japan
facility: Kohnodai Hospital, NC for Global Health and Medicine
state: Chiba
city: Matsuyama
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kasuga
country: Japan
facility: Fukuoka Tokushukai Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Steel Memorial Yawata Hospital
state: Fukuoka
city: Shirakawa
country: Japan
facility: Shirakawa Kosei General Hospital
state: Fukushima
city: Higashihiroshima
country: Japan
facility: Higashihiroshima Medical Center
state: Hiroshima
city: Obihiro
country: Japan
facility: Jiyugaoka YAMADA Clinic
state: Hokkaido
city: Naka
country: Japan
facility: Nakakinen Clinic
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic
state: Ibaraki
city: Komatsu
country: Japan
facility: Komatsu Municipal Hospital
state: Ishikawa
city: Fujisawa
country: Japan
facility: Shonan Fujisawa Tokushukai Hospital
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Suita
country: Japan
facility: Osaka Saiseikai Senri Hospital
state: Osaka
city: Kawaguchi
country: Japan
facility: Sugiura Clinic
state: Saitama
city: Oyama
country: Japan
facility: Association of healthcare corporation, Oyama East Clinic
state: Tochigi
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Nagasaki
country: Japan
facility: Japanese Red Cross Nagasaki Genbaku Hospital
city: Osaka
country: Japan
facility: Kyosokai AMC NISHI-UMEDA Clinic
city: Osaka
country: Japan
facility: Kitano Hospital
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Christian Hospital
state: Gang''weondo
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Zwijndrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, locatie Zwijndrecht
city: Braga
country: Portugal
facility: Centro Clinico Academico - Braga
city: Arkhangelsk
country: Russian Federation
facility: First City Clinical Hospital n.a. E.E. Volosevich
city: Izhevsk
country: Russian Federation
facility: Izhevsk City Clinical Hospital #9
city: Kemerovo
country: Russian Federation
facility: Sci-Res. Institute of Complex Cardiovascular Disorders
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Kirov
country: Russian Federation
facility: Center of cardiology and neurology
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
city: Moscow
country: Russian Federation
facility: Moscow State University n.a. M.V. Lomonosov
city: Moscow
country: Russian Federation
facility: Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov
city: Moscow
country: Russian Federation
facility: PHI "Central Clinical Hospital "RZD-Medicine"
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital #13 Nizhny Novgorod
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital #9
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultancy-Diagnostic Center
city: Voronezh
country: Russian Federation
facility: City Outpatient Clinic #4
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital for Emergency Care n.a. N.V.Solovyov
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: A Coruna
country: Spain
facility: Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
state: A Coruña
city: Lugar Da Pega
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
state: A Coruña
city: Jerez de la Frontera
country: Spain
facility: Hospital SAS de Jerez de la Frontera
state: Cádiz
city: Barcelona
country: Spain
facility: Hospital del Mar | Nephrology Department
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Göteborg
country: Sweden
facility: PTC-Primary care Trial Center
city: Uppsala
country: Sweden
facility: ClinSmart
city: Örebro
country: Sweden
facility: Avdelningen för kliniska prövningar AKP
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital | Nephrology Department
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: