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
- Conditions
- Chronic Kidney DiseaseType 2 Diabetes Mellitus
- Interventions
- Drug: Placebo
- Registration Number
- NCT05013008
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 951
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. Finerenone Finerenone (Kerendia, BAY94-8862) 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.
- Primary Outcome Measures
Name Time Method Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (115)
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Florida Kidney Physicians - Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Zentrum f. klinische Studien Dr. Hanusch GmbH
🇦🇹Wien, Austria
Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
🇧🇬Gorna Oryahovitsa, Bulgaria
Manna Research (Mirabel)
🇨🇦Mirabel, Quebec, Canada
Nefrologicka ambulance
🇨🇿Praha 4, Czechia
Klinik Landstraße - Krankenhaus Rudolfstiftung
🇦🇹Wien, Austria
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Randolph Medical Associates
🇺🇸Asheboro, North Carolina, United States
Illawarra Diabetes Service
🇦🇺Wollongong, New South Wales, Australia
Melbourne Renal Research Group
🇦🇺Reservoir, Victoria, Australia
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Saviers Medical Group
🇺🇸Port Hueneme, California, United States
Fukuoka Tokushukai Hospital
🇯🇵Kasuga, Fukuoka, Japan
Barzilai Medical Center | Nephrology & Hypertension Dept.
🇮🇱Ashkelon, Israel
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
UZ Gent
🇧🇪Gent, Belgium
DCC 2 - Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
Lääkärikeskus Minerva
🇫🇮Rauma, Finland
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Valley Clinical Trials, Inc. - Northridge
🇺🇸Northridge, California, United States
Sydvestjysk Sygehus Esbjerg, Endocrinology dept.
🇩🇰Esbjerg, Denmark
Clinique des Maladies Lipidques de Quebec
🇨🇦Quebec, Canada
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
AZ Delta
🇧🇪Roeselaere, Belgium
San Marcus Research Clinic, Inc.
🇺🇸Miami Lakes, Florida, United States
Terveystalo Oulu
🇫🇮Oulu, Finland
Turun yliopistollinen keskussairaala
🇫🇮Turku, Finland
Crescent City Clinical Research Center, LLC
🇺🇸Metairie, Louisiana, United States
Fukuoka University Chikushi Hospital
🇯🇵Chikushino, Fukuoka, Japan
Moscow State University n.a. M.V. Lomonosov
🇷🇺Moscow, Russian Federation
Meir Medical Center
🇮🇱Kfar Saba, Israel
Center of cardiology and neurology
🇷🇺Kirov, Russian Federation
Higashihiroshima Medical Center
🇯🇵Higashihiroshima, Hiroshima, Japan
Fraser Clinical Trials, Inc.
🇨🇦New Westminster, British Columbia, Canada
Yonsei University Wonju Christian Hospital
🇰🇷Wonju, Gang''weondo, Korea, Republic of
Komatsu Municipal Hospital
🇯🇵Komatsu, Ishikawa, Japan
Prince of Wales Hospital Hong Kong
🇭🇰Shatin, Hong Kong
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
🇪🇸Lugar Da Pega, A Coruña, Spain
ClinSmart
🇸🇪Uppsala, Sweden
Sci-Res. Institute of Complex Cardiovascular Disorders
🇷🇺Kemerovo, Russian Federation
A.O.U. di Bologna Policlinico S.Orsola Malpighi
🇮🇹Bologna, Emilia-Romagna, Italy
Nakakinen Clinic
🇯🇵Naka, Ibaraki, Japan
Voronezh Regional Clinical Consultancy-Diagnostic Center
🇷🇺Voronezh, Russian Federation
Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov
🇷🇺Moscow, Russian Federation
Hospital SAS de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Cádiz, Spain
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
PHI "Central Clinical Hospital "RZD-Medicine"
🇷🇺Moscow, Russian Federation
Izhevsk City Clinical Hospital #9
🇷🇺Izhevsk, Russian Federation
Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
🇷🇺Krasnodar, Russian Federation
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
🇪🇸A Coruna, A Coruña, Spain
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
City Clinical Hospital #13 Nizhny Novgorod
🇷🇺Nizhny Novgorod, Russian Federation
Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, Russian Federation
Saratov City Clinical Hospital #9
🇷🇺Saratov, Russian Federation
Singapore General Hospital
🇸🇬Singapore, Singapore
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Far Eastern Memorial Hospital | Nephrology Department
🇨🇳New Taipei City, Taiwan
Hospital del Mar | Nephrology Department
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
City Outpatient Clinic #4
🇷🇺Voronezh, Russian Federation
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus N, Denmark
Capital Region | Gentofte Hospital - Cardiology Research
🇩🇰Hellerup, Denmark
Herlev Hospital - Endocrinology dept.
🇩🇰Herlev, Denmark
Holbæk Sygehus
🇩🇰Holbæk, Denmark
Holstebro Hospital, Endocrinology dept.
🇩🇰Holstebro, Denmark
Bispebjerg Hospital
🇩🇰København NV, Denmark
Viborg Sygehus
🇩🇰Viborg, Denmark
Avdelningen för kliniska prövningar AKP
🇸🇪Örebro, Sweden
Clinical Hospital for Emergency Care n.a. N.V.Solovyov
🇷🇺Yaroslavl, Russian Federation
Floridian Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Hopital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
MHAT Sveti Pantaleymon - Yambol
🇧🇬Yambol, Bulgaria
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark
Edith Wolfson Medical Center
🇮🇱Holon, Israel
Hadassah Hebrew University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
The Nazareth Trust Hospital EMMS
🇮🇱Nazareth, Israel
DMC - Diabetes Medical Center
🇮🇱Tel Aviv, Israel
Clalit Health Services, Midgal Hamea
🇮🇱Tel Aviv, Israel
Kohnodai Hospital, NC for Global Health and Medicine
🇯🇵Ichikawa, Chiba, Japan
Istituto Ricerche Farmacologiche Mario Negri IRCCS
🇮🇹Bergamo, Lombardia, Italy
ASST Santi Paolo e Carlo
🇮🇹Milano, Lombardia, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
Saiseikai Matsuyama Hospital
🇯🇵Matsuyama, Ehime, Japan
Jiyugaoka YAMADA Clinic
🇯🇵Obihiro, Hokkaido, Japan
Shirakawa Kosei General Hospital
🇯🇵Shirakawa, Fukushima, Japan
Shonan Fujisawa Tokushukai Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Noritake Clinic
🇯🇵Ushiku, Ibaraki, 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
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggido, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Albert Schweitzer Ziekenhuis, locatie Zwijndrecht
🇳🇱Zwijndrecht, Netherlands
Centro Clinico Academico - Braga
🇵🇹Braga, Portugal
First City Clinical Hospital n.a. E.E. Volosevich
🇷🇺Arkhangelsk, Russian Federation
PTC-Primary care Trial Center
🇸🇪Göteborg, Sweden
Chang Gung Memorial Hospital Kaohsiung
🇨🇳Kaohsiung, Taiwan
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Tung Wah Hospital
🇭🇰Sheung Wan, Hong Kong