Trial Condition(s):
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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)
Bayer Identifier:
21952
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations San Marcus Research Clinic, Inc. Miami Lakes, United States, 33014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Valley Clinical Trials, Inc. - Northridge Northridge, United States, 91325 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Indago Research & Health Center, Inc. Hialeah, United States, 33012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East-West Medical Research Institute Honolulu, United States, 96814 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Kidney Physicians - Fort Lauderdale Fort Lauderdale, United States, 33308 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Randolph Medical Associates Asheboro, United States, 27203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Advancement Center, PLLC San Antonio, United States, 78212-4740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Floridian Clinical Research, LLC Miami Lakes, United States, 33016 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansas City VA Medical Center Kansas City, United States, 64128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saviers Medical Group Port Hueneme, United States, 93041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chase Medical Research, LLC Waterbury, United States, 06708 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Crescent City Clinical Research Center, LLC Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Joslin Diabetes Center Boston, United States, 02215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyosokai AMC NISHI-UMEDA Clinic Osaka, Japan, 530-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiyugaoka YAMADA Clinic Obihiro, Japan, 080-0848 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kitano Hospital Osaka, Japan, 530-8480 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka Tokushukai Hospital Kasuga, Japan, 816-0864 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Komatsu Municipal Hospital Komatsu, Japan, 923-8560 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nakakinen Clinic Naka, Japan, 311-0113 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki, Japan, 852-8511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shirakawa Kosei General Hospital Shirakawa, Japan, 961-0005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Matsuyama Hospital Matsuyama, Japan, 791-8026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steel Memorial Yawata Hospital Kitakyushu, Japan, 805-8508 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kohnodai Hospital, NC for Global Health and Medicine Ichikawa, Japan, 272-8516 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Chikushi Hospital Chikushino, Japan, 818-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Noritake Clinic Ushiku, Japan, 300-1207 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Hospital Fukuoka, Japan, 814-0180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Association of healthcare corporation, Oyama East Clinic Oyama, Japan, 323-0022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka Saiseikai Senri Hospital Suita, Japan, 565-0862 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sugiura Clinic Kawaguchi, Japan, 332-0012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Higashihiroshima Medical Center Higashihiroshima, Japan, 739-0041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Ricerche Farmacologiche Mario Negri IRCCS Bergamo, Italy, 24020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Santi Paolo e Carlo Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial Lugar da Pega, Spain, 15405 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition A Coruna, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital SAS de Jerez de la Frontera Jerez de la Frontera, Spain, 11407 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar | Nephrology Department Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta ROESELAERE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avdelningen för kliniska prövningar AKP Örebro, Sweden, 703 62 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ClinSmart Uppsala, Sweden, 752 37 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PTC-Primary care Trial Center Göteborg, Sweden, 413 46 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center | Nephrology & Hypertension Dept. Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Edith Wolfson Medical Center Holon, Israel, 5822012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DMC - Diabetes Medical Center Tel Aviv, Israel, 6937947 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services, Midgal Hamea Tel Aviv, Israel, 6203854 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Melbourne Renal Research Group Reservoir, Australia, 3073 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Illawarra Diabetes Service Wollongong, Australia, 2500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveti Pantaleymon - Yambol Yambol, Bulgaria, 8600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department Gorna Oryahovitsa, Bulgaria, 5100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DCC 2 - Plovdiv EOOD Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kemerovo Regional Clinical Hospital Kemerovo, Russia, 650066 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Center of cardiology and neurology Kirov, Russia, 610014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PHI "Central Clinical Hospital "RZD-Medicine" Moscow, Russia, 125315 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Voronezh Regional Clinical Consultancy-Diagnostic Center Voronezh, Russia, 394018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Outpatient Clinic #4 Voronezh, Russia, 394077 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sci-Res. Institute of Complex Cardiovascular Disorders Kemerovo, Russia, 650002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky Krasnodar, Russia, 350086 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saratov City Clinical Hospital #9 Saratov, Russia, 410030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First City Clinical Hospital n.a. E.E. Volosevich Arkhangelsk, Russia, 163001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov Moscow, Russia, 123182 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Hospital for Emergency Care n.a. N.V.Solovyov Yaroslavl, Russia, 150003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Moscow State University n.a. M.V. Lomonosov Moscow, Russia, 119192 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #13 Nizhny Novgorod Nizhny Novgorod, Russia, 603018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Izhevsk City Clinical Hospital #9 Izhevsk, Russia, 426063 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hallym University Sacred Heart Hospital Anyang-si, South Korea, 14068 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Anam Hospital Seoul, South Korea, 02841 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyung Hee University Hospital at Gangdong Seoul, South Korea, 05278 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 3722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yonsei University Wonju Christian Hospital Wonju, South Korea, 26426 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kangbuk Samsung Hospital Seoul, South Korea, 110-746 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Far Eastern Memorial Hospital | Nephrology Department New Taipei City, Taiwan, China, 220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University Hospital Taipei, Taiwan, China, 110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tung Wah Hospital Sheung Wan, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Heart Centre Singapore Singapore, Singapore, 169609 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Nazareth Trust Hospital EMMS Nazareth, Israel, 16100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nefrologicka ambulance Praha 4, Czech Republic, 140 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Landstraße - Krankenhaus Rudolfstiftung Wien, Austria, 1030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zentrum f. klinische Studien Dr. Hanusch GmbH Wien, Austria, 1060 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, locatie Zwijndrecht ZWIJNDRECHT, Netherlands, 3331 LZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manna Research (Mirabel) Mirabel, Canada, J7J 2K8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique des Maladies Lipidques de Quebec Quebec, Canada, G1V 4W1 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fraser Clinical Trials, Inc. New Westminster, Canada, V3L 3W4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Charles LeMoyne Greenfield Park, Canada, J4V 2H1 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holstebro Hospital, Endocrinology dept. Holstebro, Denmark, DK-7500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steno Diabetes Center Copenhagen Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Herlev Hospital - Endocrinology dept. Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bispebjerg Hospital København NV, Denmark, 2400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holbæk Sygehus Holbæk, Denmark, 4300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydvestjysk Sygehus Esbjerg, Endocrinology dept. Esbjerg, Denmark, 6700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Viborg Sygehus Viborg, Denmark, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Capital Region | Gentofte Hospital - Cardiology Research Hellerup, Denmark, 2900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Terveystalo Oulu Oulu, Finland, 90100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkärikeskus Minerva Rauma, Finland, 26100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A non-blinded retrospective biomarker add-on study to FIGARO-DKD for bioprofiling the pharmacodynamic response to finerenone in FIGARO-DKD subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Mean change in plasma biomarker levels after 36 months of treatment versus 4 months of treatment in a set of 27 pre-defined biomarkersThe 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.Timeframe: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment
Additional Information
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