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:

NCT05013008

EudraCT Number:

2021-003053-37

Study Completed

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
951
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

San Marcus Research Clinic, Inc.

Miami Lakes, United States, 33014

Status
Completed
 
Locations

Valley Clinical Trials, Inc. - Northridge

Northridge, United States, 91325

Status
Completed
 
Locations

Indago Research & Health Center, Inc.

Hialeah, United States, 33012

Status
Completed
 
Locations

East-West Medical Research Institute

Honolulu, United States, 96814

Status
Completed
 
Locations

Florida Kidney Physicians - Fort Lauderdale

Fort Lauderdale, United States, 33308

Status
Completed
 
Locations

Randolph Medical Associates

Asheboro, United States, 27203

Status
Completed
 
Locations

Clinical Advancement Center, PLLC

San Antonio, United States, 78212-4740

Status
Completed
 
Locations

Floridian Clinical Research, LLC

Miami Lakes, United States, 33016

Status
Completed
 
Locations

Kansas City VA Medical Center

Kansas City, United States, 64128

Status
Completed
 
Locations

Saviers Medical Group

Port Hueneme, United States, 93041

Status
Completed
 
Locations

Chase Medical Research, LLC

Waterbury, United States, 06708

Status
Completed
 
Locations

Crescent City Clinical Research Center, LLC

Metairie, United States, 70006

Status
Completed
 
Locations

Joslin Diabetes Center

Boston, United States, 02215

Status
Completed
 
Locations

Kyosokai AMC NISHI-UMEDA Clinic

Osaka, Japan, 530-0001

Status
Completed
 
Locations

Jiyugaoka YAMADA Clinic

Obihiro, Japan, 080-0848

Status
Completed
 
Locations

Shonan Kamakura General Hospital

Kamakura, Japan, 247-8533

Status
Completed
 
Locations

Kitano Hospital

Osaka, Japan, 530-8480

Status
Completed
 
Locations

Fukuoka Tokushukai Hospital

Kasuga, Japan, 816-0864

Status
Completed
 
Locations

Komatsu Municipal Hospital

Komatsu, Japan, 923-8560

Status
Completed
 
Locations

Nakakinen Clinic

Naka, Japan, 311-0113

Status
Completed
 
Locations

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Japan, 852-8511

Status
Completed
 
Locations

Shirakawa Kosei General Hospital

Shirakawa, Japan, 961-0005

Status
Completed
 
Locations

Saiseikai Matsuyama Hospital

Matsuyama, Japan, 791-8026

Status
Completed
 
Locations

Japanese Red Cross Kumamoto Hospital

Kumamoto, Japan, 861-8520

Status
Completed
 
Locations

Steel Memorial Yawata Hospital

Kitakyushu, Japan, 805-8508

Status
Completed
 
Locations

Kohnodai Hospital, NC for Global Health and Medicine

Ichikawa, Japan, 272-8516

Status
Completed
 
Locations

Fukuoka University Chikushi Hospital

Chikushino, Japan, 818-8502

Status
Completed
 
Locations

Noritake Clinic

Ushiku, Japan, 300-1207

Status
Completed
 
Locations

Fukuoka University Hospital

Fukuoka, Japan, 814-0180

Status
Completed
 
Locations

Association of healthcare corporation, Oyama East Clinic

Oyama, Japan, 323-0022

Status
Completed
 
Locations

Osaka Saiseikai Senri Hospital

Suita, Japan, 565-0862

Status
Completed
 
Locations

Sugiura Clinic

Kawaguchi, Japan, 332-0012

Status
Completed
 
Locations

Higashihiroshima Medical Center

Higashihiroshima, Japan, 739-0041

Status
Completed
 
Locations

Kokura Memorial Hospital

Kitakyushu, Japan, 802-8555

Status
Completed
 
Locations

Istituto Ricerche Farmacologiche Mario Negri IRCCS

Bergamo, Italy, 24020

Status
Completed
 
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Completed
 
Locations

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

ASST Santi Paolo e Carlo

Milano, Italy, 20142

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Complexo Hospitalario Universitario de Ferrol

Lugar da Pega, Spain, 15405

Status
Completed
 
Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Status
Completed
 
Locations

Hospital SAS de Jerez de la Frontera

Jerez de la Frontera, Spain, 11407

Status
Completed
 
Locations

Hospital del Mar | Nephrology Department

Barcelona, Spain, 08003

Status
Completed
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

AZ Delta

ROESELAERE, Belgium, 8800

Status
Completed
 
Locations

Avdelningen för kliniska prövningar AKP

Örebro, Sweden, 703 62

Status
Completed
 
Locations

ClinSmart

Uppsala, Sweden, 752 37

Status
Completed
 
Locations

PTC-Primary care Trial Center

Göteborg, Sweden, 413 46

Status
Completed
 
Locations

Barzilai Medical Center | Nephrology & Hypertension Dept.

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 5822012

Status
Completed
 
Locations

DMC - Diabetes Medical Center

Tel Aviv, Israel, 6937947

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Clalit Health Services, Midgal Hamea

Tel Aviv, Israel, 6203854

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Melbourne Renal Research Group

Reservoir, Australia, 3073

Status
Completed
 
Locations

Illawarra Diabetes Service

Wollongong, Australia, 2500

Status
Completed
 
Locations

MHAT Sveti Pantaleymon - Yambol

Yambol, Bulgaria, 8600

Status
Completed
 
Locations

MHAT St. Ivan Rilski

Gorna Oryahovitsa, Bulgaria, 5100

Status
Completed
 
Locations

DCC 2 - Plovdiv EOOD

Plovdiv, Bulgaria, 4002

Status
Completed
 
Locations

Centro Clinico Academico - Braga

Braga, Portugal, 4710-243

Status
Completed
 
Locations

Kemerovo Regional Clinical Hospital

Kemerovo, Russia, 650066

Status
Completed
 
Locations

Center of cardiology and neurology

Kirov, Russia, 610014

Status
Completed
 
Locations

PHI "Central Clinical Hospital "RZD-Medicine"

Moscow, Russia, 125315

Status
Completed
 
Locations

Voronezh Regional Clinical Consultancy-Diagnostic Center

Voronezh, Russia, 394018

Status
Completed
 
Locations

City Outpatient Clinic #4

Voronezh, Russia, 394077

Status
Completed
 
Locations

Sci-Res. Institute of Complex Cardiovascular Disorders

Kemerovo, Russia, 650002

Status
Completed
 
Locations

Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

Krasnodar, Russia, 350086

Status
Completed
 
Locations

Saratov City Clinical Hospital #9

Saratov, Russia, 410030

Status
Completed
 
Locations

First City Clinical Hospital n.a. E.E. Volosevich

Arkhangelsk, Russia, 163001

Status
Completed
 
Locations

Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov

Moscow, Russia, 123182

Status
Completed
 
Locations

Clinical Hospital for Emergency Care n.a. N.V.Solovyov

Yaroslavl, Russia, 150003

Status
Completed
 
Locations

Moscow State University n.a. M.V. Lomonosov

Moscow, Russia, 119192

Status
Completed
 
Locations

City Clinical Hospital #13 Nizhny Novgorod

Nizhny Novgorod, Russia, 603018

Status
Completed
 
Locations

Izhevsk City Clinical Hospital #9

Izhevsk, Russia, 426063

Status
Completed
 
Locations

Hallym University Sacred Heart Hospital

Anyang-si, South Korea, 14068

Status
Completed
 
Locations

Korea University Anam Hospital

Seoul, South Korea, 02841

Status
Completed
 
Locations

Kyung Hee University Hospital at Gangdong

Seoul, South Korea, 05278

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 03080

Status
Completed
 
Locations

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Completed
 
Locations

Yonsei University Wonju Christian Hospital

Wonju, South Korea, 26426

Status
Completed
 
Locations

Kangbuk Samsung Hospital

Seoul, South Korea, 110-746

Status
Completed
 
Locations

Far Eastern Memorial Hospital

New Taipei City, Taiwan, China, 220

Status
Completed
 
Locations

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, China, 833

Status
Completed
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 50006

Status
Completed
 
Locations

Taipei Medical University Hospital

Taipei, Taiwan, China, 110

Status
Completed
 
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Prince of Wales Hospital Hong Kong

Shatin, Hong Kong, China

Status
Completed
 
Locations

Tung Wah Hospital

Sheung Wan, Hong Kong, China

Status
Completed
 
Locations

Singapore General Hospital

Singapore, Singapore, 169608

Status
Completed
 
Locations

National Heart Centre Singapore

Singapore, Singapore, 169609

Status
Completed
 
Locations

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Japan, 251-0041

Status
Completed
 
Locations

The Nazareth Trust Hospital EMMS

Nazareth, Israel, 16100

Status
Completed
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Nefrologicka ambulance

Praha 4, Czech Republic, 140 00

Status
Completed
 
Locations

Klinik Landstraße - Krankenhaus Rudolfstiftung

Wien, Austria, 1030

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Zentrum f. klinische Studien Dr. Hanusch GmbH

Wien, Austria, 1060

Status
Completed
 
Locations

Albert Schweitzer Ziekenhuis, locatie Zwijndrecht

ZWIJNDRECHT, Netherlands, 3331 LZ

Status
Completed
 
Locations

Manna Research (Mirabel)

Mirabel, Canada, J7J 2K8

Status
Completed
 
Locations

Clinique des Maladies Lipidques de Quebec

Quebec, Canada, G1V 4W1

Status
Completed
 
Locations

Fraser Clinical Trials, Inc.

New Westminster, Canada, V3L 3W4

Status
Completed
 
Locations

Hopital Charles LeMoyne

Greenfield Park, Canada, J4V 2H1

Status
Completed
 
Locations

Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Holstebro Hospital, Endocrinology dept.

Holstebro, Denmark, DK-7500

Status
Completed
 
Locations

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Status
Completed
 
Locations

Herlev Hospital - Endocrinology dept.

Herlev, Denmark, 2730

Status
Completed
 
Locations

Bispebjerg Hospital

København NV, Denmark, 2400

Status
Completed
 
Locations

Holbæk Sygehus

Holbæk, Denmark, 4300

Status
Completed
 
Locations

Sydvestjysk Sygehus Esbjerg, Endocrinology dept.

Esbjerg, Denmark, 6700

Status
Completed
 
Locations

Viborg Sygehus

Viborg, Denmark, 8800

Status
Completed
 
Locations

Capital Region | Gentofte Hospital - Cardiology Research

Hellerup, Denmark, 2900

Status
Completed
 
Locations

Terveystalo Oulu

Oulu, Finland, 90100

Status
Completed
 
Locations

Turun yliopistollinen keskussairaala

Turku, Finland, 20520

Status
Completed
 
Locations

Lääkärikeskus Minerva

Rauma, Finland, 26100

Status
Completed
 

Trial Design