Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1267
Source ID: NCT05013008
Associated Drug: Finerenone (Kerendia, Bay94-8862)
Title: 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
Acronym: FIGARO-BM
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05013008/results
Conditions: Chronic Kidney Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Finerenone (Kerendia, BAY94-8862)|DRUG: Placebo
Outcome Measures: 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 |
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 951
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2021-08-18
Completion Date: 2021-12-31
Results First Posted: 2023-03-31
Last Update Posted: 2023-09-15
Locations: Valley Clinical Trials, Inc. - Northridge, Northridge, California, 91325, United States|Saviers Medical Group, Port Hueneme, California, 93041, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Florida Kidney Physicians - Fort Lauderdale, Fort Lauderdale, Florida, 33308, United States|Indago Research & Health Center, Inc., Hialeah, Florida, 33012, United States|San Marcus Research Clinic, Inc., Miami Lakes, Florida, 33014, United States|Floridian Clinical Research, LLC, Miami Lakes, Florida, 33016, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Crescent City Clinical Research Center, LLC, Metairie, Louisiana, 70006, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Kansas City VA Medical Center, Kansas City, Missouri, 64128, United States|Randolph Medical Associates, Asheboro, North Carolina, 27203, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78212-4740, United States|Illawarra Diabetes Service, Wollongong, New South Wales, 2500, Australia|Melbourne Renal Research Group, Reservoir, Victoria, 3073, Australia|Medizinische Universität Graz, Graz, Steiermark, 8036, Austria|Klinik Landstraße - Krankenhaus Rudolfstiftung, Wien, 1030, Austria|Zentrum f. klinische Studien Dr. Hanusch GmbH, Wien, 1060, Austria|UZ Gent, Gent, 9000, Belgium|AZ Delta, Roeselaere, 8800, Belgium|Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department, Gorna Oryahovitsa, 5100, Bulgaria|DCC 2 - Plovdiv EOOD, Plovdiv, 4002, Bulgaria|MHAT Sveti Pantaleymon - Yambol, Yambol, 8600, Bulgaria|Fraser Clinical Trials, Inc., New Westminster, British Columbia, V3L 3W4, Canada|Hopital Charles LeMoyne, Greenfield Park, Quebec, J4V 2H1, Canada|Manna Research (Mirabel), Mirabel, Quebec, J7J 2K8, Canada|Clinique des Maladies Lipidques de Quebec, Quebec, G1V 4W1, Canada|Nefrologicka ambulance, Praha 4, 140 00, Czechia|Aarhus Universitetshospital, Skejby, Aarhus N, 8200, Denmark|Sydvestjysk Sygehus Esbjerg, Endocrinology dept., Esbjerg, 6700, Denmark|Capital Region | Gentofte Hospital - Cardiology Research, Hellerup, 2900, Denmark|Herlev Hospital - Endocrinology dept., Herlev, 2730, Denmark|Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark|Holbæk Sygehus, Holbæk, 4300, Denmark|Holstebro Hospital, Endocrinology dept., Holstebro, DK-7500, Denmark|Bispebjerg Hospital, København NV, 2400, Denmark|Viborg Sygehus, Viborg, 8800, Denmark|Terveystalo Oulu, Oulu, 90100, Finland|Lääkärikeskus Minerva, Rauma, 26100, Finland|Turun yliopistollinen keskussairaala, Turku, 20520, 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, 7830604, Israel|Edith Wolfson Medical Center, Holon, 5822012, Israel|Hadassah Hebrew University Hospital Ein Kerem, Jerusalem, 9112001, Israel|Meir Medical Center, Kfar Saba, 4428164, Israel|The Nazareth Trust Hospital EMMS, Nazareth, 16100, Israel|Clalit Health Services, Midgal Hamea, Tel Aviv, 6203854, Israel|DMC - Diabetes Medical Center, Tel Aviv, 6937947, Israel|A.O.U. di Bologna Policlinico S.Orsola Malpighi, Bologna, Emilia-Romagna, 40138, Italy|Istituto Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Lombardia, 24020, Italy|ASST Papa Giovanni XXIII, Bergamo, Lombardia, 24127, Italy|ASST Santi Paolo e Carlo, Milano, Lombardia, 20142, Italy|Kohnodai Hospital, NC for Global Health and Medicine, Ichikawa, Chiba, 272-8516, Japan|Saiseikai Matsuyama Hospital, Matsuyama, Ehime, 791-8026, Japan|Fukuoka University Chikushi Hospital, Chikushino, Fukuoka, 818-8502, Japan|Fukuoka Tokushukai Hospital, Kasuga, Fukuoka, 816-0864, Japan|Kokura Memorial Hospital, Kitakyushu, Fukuoka, 802-8555, Japan|Steel Memorial Yawata Hospital, Kitakyushu, Fukuoka, 805-8508, Japan|Shirakawa Kosei General Hospital, Shirakawa, Fukushima, 961-0005, Japan|Higashihiroshima Medical Center, Higashihiroshima, Hiroshima, 739-0041, Japan|Jiyugaoka YAMADA Clinic, Obihiro, Hokkaido, 080-0848, Japan|Nakakinen Clinic, Naka, Ibaraki, 311-0113, Japan|Noritake Clinic, Ushiku, Ibaraki, 300-1207, Japan|Komatsu Municipal Hospital, Komatsu, Ishikawa, 923-8560, Japan|Shonan Fujisawa Tokushukai Hospital, Fujisawa, Kanagawa, 251-0041, Japan|Shonan Kamakura General Hospital, Kamakura, Kanagawa, 247-8533, Japan|Osaka Saiseikai Senri Hospital, Suita, Osaka, 565-0862, Japan|Sugiura Clinic, Kawaguchi, Saitama, 332-0012, Japan|Association of healthcare corporation, Oyama East Clinic, Oyama, Tochigi, 323-0022, Japan|Fukuoka University Hospital, Fukuoka, 814-0180, Japan|Japanese Red Cross Kumamoto Hospital, Kumamoto, 861-8520, Japan|Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, 852-8511, Japan|Kyosokai AMC NISHI-UMEDA Clinic, Osaka, 530-0001, Japan|Kitano Hospital, Osaka, 530-8480, Japan|Yonsei University Wonju Christian Hospital, Wonju, Gang''weondo, 26426, Korea, Republic of|Hallym University Sacred Heart Hospital, Anyang-si, Gyeonggido, 14068, Korea, Republic of|Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, 03080, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Kyung Hee University Hospital at Gangdong, Seoul, 05278, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, 110-746, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 3722, Korea, Republic of|Albert Schweitzer Ziekenhuis, locatie Zwijndrecht, Zwijndrecht, 3331 LZ, Netherlands|Centro Clinico Academico - Braga, Braga, 4710-243, Portugal|First City Clinical Hospital n.a. E.E. Volosevich, Arkhangelsk, 163001, Russian Federation|Izhevsk City Clinical Hospital #9, Izhevsk, 426063, Russian Federation|Sci-Res. Institute of Complex Cardiovascular Disorders, Kemerovo, 650002, Russian Federation|Kemerovo Regional Clinical Hospital, Kemerovo, 650066, Russian Federation|Center of cardiology and neurology, Kirov, 610014, Russian Federation|Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky, Krasnodar, 350086, Russian Federation|Moscow State University n.a. M.V. Lomonosov, Moscow, 119192, Russian Federation|Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov, Moscow, 123182, Russian Federation|PHI "Central Clinical Hospital "RZD-Medicine", Moscow, 125315, Russian Federation|City Clinical Hospital #13 Nizhny Novgorod, Nizhny Novgorod, 603018, Russian Federation|Saratov City Clinical Hospital #9, Saratov, 410030, Russian Federation|Voronezh Regional Clinical Consultancy-Diagnostic Center, Voronezh, 394018, Russian Federation|City Outpatient Clinic #4, Voronezh, 394077, Russian Federation|Clinical Hospital for Emergency Care n.a. N.V.Solovyov, Yaroslavl, 150003, Russian Federation|Singapore General Hospital, Singapore, 169608, Singapore|National Heart Centre Singapore, Singapore, 169609, Singapore|Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition, A Coruna, A Coruña, 15006, Spain|Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial, Lugar Da Pega, A Coruña, 15405, Spain|Hospital SAS de Jerez de la Frontera, Jerez de la Frontera, Cádiz, 11407, Spain|Hospital del Mar | Nephrology Department, Barcelona, 08003, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|PTC-Primary care Trial Center, Göteborg, 413 46, Sweden|ClinSmart, Uppsala, 752 37, Sweden|Avdelningen för kliniska prövningar AKP, Örebro, 703 62, Sweden|Changhua Christian Hospital, Changhua, 50006, Taiwan|Chang Gung Memorial Hospital Kaohsiung, Kaohsiung, 833, Taiwan|Far Eastern Memorial Hospital | Nephrology Department, New Taipei City, 220, Taiwan|Taichung Veterans General Hospital, Taichung, 40705, Taiwan|Taipei Medical University Hospital, Taipei, 110, Taiwan|Taipei Veterans General Hospital, Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT05013008

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress