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
| Locations | Status | |
|---|---|---|
Locations San Marcus Research Clinic, Inc. Miami Lakes, United States, 33014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Valley Clinical Trials, Inc. - Northridge Northridge, United States, 91325 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Indago Research & Health Center, Inc. Hialeah, United States, 33012 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East-West Medical Research Institute Honolulu, United States, 96814 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Kidney Physicians - Fort Lauderdale Fort Lauderdale, United States, 33308 | Status Completed | Contact Us: E-mail: clin[email protected] Phone: (+)1-888-84 22937 |
Locations Randolph Medical Associates Asheboro, United States, 27203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Advancement Center, PLLC San Antonio, United States, 78212-4740 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Floridian Clinical Research, LLC Miami Lakes, United States, 33016 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansas City VA Medical Center Kansas City, United States, 64128 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saviers Medical Group Port Hueneme, United States, 93041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chase Medical Research, LLC Waterbury, United States, 06708 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Crescent City Clinical Research Center, LLC Metairie, United States, 70006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Joslin Diabetes Center Boston, United States, 02215 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyosokai AMC NISHI-UMEDA Clinic Osaka, Japan, 530-0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiyugaoka YAMADA Clinic Obihiro, Japan, 080-0848 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Kamakura General Hospital Kamakura, Japan, 247-8533 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kitano Hospital Osaka, Japan, 530-8480 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka Tokushukai Hospital Kasuga, Japan, 816-0864 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Komatsu Municipal Hospital Komatsu, Japan, 923-8560 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nakakinen Clinic Naka, Japan, 311-0113 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Nagasaki Genbaku Hospital Nagasaki, Japan, 852-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shirakawa Kosei General Hospital Shirakawa, Japan, 961-0005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiseikai Matsuyama Hospital Matsuyama, Japan, 791-8026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steel Memorial Yawata Hospital Kitakyushu, Japan, 805-8508 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kohnodai Hospital, NC for Global Health and Medicine Ichikawa, Japan, 272-8516 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Chikushi Hospital Chikushino, Japan, 818-8502 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Noritake Clinic Ushiku, Japan, 300-1207 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Hospital Fukuoka, Japan, 814-0180 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Association of healthcare corporation, Oyama East Clinic Oyama, Japan, 323-0022 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka Saiseikai Senri Hospital Suita, Japan, 565-0862 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sugiura Clinic Kawaguchi, Japan, 332-0012 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Higashihiroshima Medical Center Higashihiroshima, Japan, 739-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Ricerche Farmacologiche Mario Negri IRCCS Bergamo, Italy, 24020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Santi Paolo e Carlo Milano, Italy, 20142 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario 12 de Octubre Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complexo Hospitalario Universitario de Ferrol Lugar da Pega, Spain, 15405 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario Universitario A Coruña A Coruña, Spain, 15006 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar | Nephrology Department Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Delta ROESELAERE, Belgium, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avdelningen för kliniska prövningar AKP Örebro, Sweden, 703 62 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ClinSmart Uppsala, Sweden, 752 37 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PTC-Primary care Trial Center Göteborg, Sweden, 413 46 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center | Nephrology & Hypertension Dept. Ashkelon, Israel, 7830604 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Edith Wolfson Medical Center Holon, Israel, 5822012 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DMC - Diabetes Medical Center Tel Aviv, Israel, 6937947 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services, Midgal Hamea Tel Aviv, Israel, 6203854 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Melbourne Renal Research Group Reservoir, Australia, 3073 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Illawarra Diabetes Service Wollongong, Australia, 2500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveti Pantaleymon - Yambol Yambol, Bulgaria, 8600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT St. Ivan Rilski Gorna Oryahovitsa, Bulgaria, 5100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DCC 2 - Plovdiv EOOD Plovdiv, Bulgaria, 4002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kemerovo Regional Clinical Hospital Kemerovo, Russia, 650066 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Center of cardiology and neurology Kirov, Russia, 610014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PHI "Central Clinical Hospital "RZD-Medicine" Moscow, Russia, 125315 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Voronezh Regional Clinical Consultancy-Diagnostic Center Voronezh, Russia, 394018 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Outpatient Clinic #4 Voronezh, Russia, 394077 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sci-Res. Institute of Complex Cardiovascular Disorders Kemerovo, Russia, 650002 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saratov City Clinical Hospital #9 Saratov, Russia, 410030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First City Clinical Hospital n.a. E.E. Volosevich Arkhangelsk, Russia, 163001 | Status Completed | 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 | Status Completed | 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 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Moscow State University n.a. M.V. Lomonosov Moscow, Russia, 119192 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #13 Nizhny Novgorod Nizhny Novgorod, Russia, 603018 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Izhevsk City Clinical Hospital #9 Izhevsk, Russia, 426063 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hallym University Sacred Heart Hospital Anyang-si, South Korea, 14068 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Korea University Anam Hospital Seoul, South Korea, 02841 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyung Hee University Hospital at Gangdong Seoul, South Korea, 05278 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yonsei University Wonju Christian Hospital Wonju, South Korea, 26426 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kangbuk Samsung Hospital Seoul, South Korea, 110-746 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Far Eastern Memorial Hospital New Taipei City, Taiwan, China, 220 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University Hospital Taipei, Taiwan, China, 110 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tung Wah Hospital Sheung Wan, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Heart Centre Singapore Singapore, Singapore, 169609 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Nazareth Trust Hospital EMMS Nazareth, Israel, 16100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nefrologicka ambulance Praha 4, Czech Republic, 140 00 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Landstraße - Krankenhaus Rudolfstiftung Wien, Austria, 1030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zentrum f. klinische Studien Dr. Hanusch GmbH Wien, Austria, 1060 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, locatie Zwijndrecht ZWIJNDRECHT, Netherlands, 3331 LZ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Manna Research (Mirabel) Mirabel, Canada, J7J 2K8 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique des Maladies Lipidques de Quebec Quebec, Canada, G1V 4W1 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fraser Clinical Trials, Inc. New Westminster, Canada, V3L 3W4 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Charles LeMoyne Greenfield Park, Canada, J4V 2H1 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holstebro Hospital, Endocrinology dept. Holstebro, Denmark, DK-7500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steno Diabetes Center Copenhagen Herlev, Denmark, 2730 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Herlev Hospital - Endocrinology dept. Herlev, Denmark, 2730 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bispebjerg Hospital København NV, Denmark, 2400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holbæk Sygehus Holbæk, Denmark, 4300 | Status Completed | Contact Us: E-mail: clinical-tria[email protected] Phone: (+)1-888-84 22937 |
Locations Sydvestjysk Sygehus Esbjerg, Endocrinology dept. Esbjerg, Denmark, 6700 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Viborg Sygehus Viborg, Denmark, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Capital Region | Gentofte Hospital - Cardiology Research Hellerup, Denmark, 2900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Terveystalo Oulu Oulu, Finland, 90100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, 20520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lääkärikeskus Minerva Rauma, Finland, 26100 | Status Completed | 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. 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. TGF: Transforming growth factor; TNFRSF1A: Tumor necrosis factor receptor superfamily member 1A; PAI-1: Plasminogen activator inhibitor 1; uPAR: Urokinase plasminogen activator surface receptor; RARRES2: Retinoic acid receptor responder protein 2Timeframe: At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment
Additional Information
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