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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)

Primary Purpose

Chronic Kidney Disease, Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Finerenone (Kerendia, BAY94-8862)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Valley Clinical Trials, Inc. - Northridge
  • Saviers Medical Group
  • Chase Medical Research, LLC
  • Florida Kidney Physicians - Fort Lauderdale
  • Indago Research & Health Center, Inc.
  • San Marcus Research Clinic, Inc.
  • Floridian Clinical Research, LLC
  • East-West Medical Research Institute
  • Crescent City Clinical Research Center, LLC
  • Joslin Diabetes Center
  • Kansas City VA Medical Center
  • Randolph Medical Associates
  • Clinical Advancement Center, PLLC
  • Illawarra Diabetes Service
  • Melbourne Renal Research Group
  • Medizinische Universität Graz
  • Klinik Landstraße - Krankenhaus Rudolfstiftung
  • Zentrum f. klinische Studien Dr. Hanusch GmbH
  • UZ Gent
  • AZ Delta
  • Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department
  • DCC 2 - Plovdiv EOOD
  • MHAT Sveti Pantaleymon - Yambol
  • Fraser Clinical Trials, Inc.
  • Hopital Charles LeMoyne
  • Manna Research (Mirabel)
  • Clinique des Maladies Lipidques de Quebec
  • Nefrologicka ambulance
  • Aarhus Universitetshospital, Skejby
  • Sydvestjysk Sygehus Esbjerg, Endocrinology dept.
  • Capital Region | Gentofte Hospital - Cardiology Research
  • Herlev Hospital - Endocrinology dept.
  • Steno Diabetes Center Copenhagen
  • Holbæk Sygehus
  • Holstebro Hospital, Endocrinology dept.
  • Bispebjerg Hospital
  • Viborg Sygehus
  • Terveystalo Oulu
  • Lääkärikeskus Minerva
  • Turun yliopistollinen keskussairaala
  • Queen Mary Hospital
  • Prince of Wales Hospital Hong Kong
  • Tung Wah Hospital
  • Barzilai Medical Center | Nephrology & Hypertension Dept.
  • Edith Wolfson Medical Center
  • Hadassah Hebrew University Hospital Ein Kerem
  • Meir Medical Center
  • The Nazareth Trust Hospital EMMS
  • Clalit Health Services, Midgal Hamea
  • DMC - Diabetes Medical Center
  • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • Istituto Ricerche Farmacologiche Mario Negri IRCCS
  • ASST Papa Giovanni XXIII
  • ASST Santi Paolo e Carlo
  • Kohnodai Hospital, NC for Global Health and Medicine
  • Saiseikai Matsuyama Hospital
  • Fukuoka University Chikushi Hospital
  • Fukuoka Tokushukai Hospital
  • Kokura Memorial Hospital
  • Steel Memorial Yawata Hospital
  • Shirakawa Kosei General Hospital
  • Higashihiroshima Medical Center
  • Jiyugaoka YAMADA Clinic
  • Nakakinen Clinic
  • Noritake Clinic
  • Komatsu Municipal Hospital
  • Shonan Fujisawa Tokushukai Hospital
  • Shonan Kamakura General Hospital
  • Osaka Saiseikai Senri Hospital
  • Sugiura Clinic
  • Association of healthcare corporation, Oyama East Clinic
  • Fukuoka University Hospital
  • Japanese Red Cross Kumamoto Hospital
  • Japanese Red Cross Nagasaki Genbaku Hospital
  • Kyosokai AMC NISHI-UMEDA Clinic
  • Kitano Hospital
  • Yonsei University Wonju Christian Hospital
  • Hallym University Sacred Heart Hospital
  • Seoul National University Hospital
  • Korea University Anam Hospital
  • Kyung Hee University Hospital at Gangdong
  • Kangbuk Samsung Hospital
  • Severance Hospital, Yonsei University Health System
  • Albert Schweitzer Ziekenhuis, locatie Zwijndrecht
  • Centro Clinico Academico - Braga
  • First City Clinical Hospital n.a. E.E. Volosevich
  • Izhevsk City Clinical Hospital #9
  • Sci-Res. Institute of Complex Cardiovascular Disorders
  • Kemerovo Regional Clinical Hospital
  • Center of cardiology and neurology
  • Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky
  • Moscow State University n.a. M.V. Lomonosov
  • Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov
  • PHI "Central Clinical Hospital "RZD-Medicine"
  • City Clinical Hospital #13 Nizhny Novgorod
  • Saratov City Clinical Hospital #9
  • Voronezh Regional Clinical Consultancy-Diagnostic Center
  • City Outpatient Clinic #4
  • Clinical Hospital for Emergency Care n.a. N.V.Solovyov
  • Singapore General Hospital
  • National Heart Centre Singapore
  • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
  • Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
  • Hospital SAS de Jerez de la Frontera
  • Hospital del Mar | Nephrology Department
  • Hospital Universitario 12 de Octubre
  • PTC-Primary care Trial Center
  • ClinSmart
  • Avdelningen för kliniska prövningar AKP
  • Changhua Christian Hospital
  • Chang Gung Memorial Hospital Kaohsiung
  • Far Eastern Memorial Hospital | Nephrology Department
  • Taichung Veterans General Hospital
  • Taipei Medical University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Finerenone

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2021
Last Updated
September 14, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05013008
Brief 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
Official Title
A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
951 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Finerenone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Finerenone (Kerendia, BAY94-8862)
Intervention Description
Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study.
Primary Outcome Measure Information:
Title
Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers
Description
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.
Time Frame
At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/study/21952
Description
Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

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

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