Back to resultsA Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE)
Primary Purpose
Chronic Kidney Disease, Type 1 Diabetes Mellitus
Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Finerenone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria: Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent. Participants with Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin, started within one year from diagnosis. If the onset was after age 35, documentation of the presence of one or more of the following: Circulating T1D-associated autoantibodies Hospitalization for diabetic ketoacidosis Plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dl). HbA1c at Screening <10% (central assessment). Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid. K+ ≤ 4.8 mmol/L at Screening (local assessment) Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment): eGFR ≥25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment. Exclusion Criteria: Participant with T2D (Type 2 diabetes). Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs). Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 (Glucagon-like peptide-1) receptor agonist.
Sites / Locations
- Stanford Health Care (SHC)
- Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California
- University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC)
- Christiana Care Health System (Services)
- University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center
- Elixia Central Florida
- Hanson Clinical Research Center, Inc.
- Jedidiah Clinical Research
- Metabolic Research Institute, Inc.
- Morehouse School of Medicine | Clinical Research Centre
- Northwestern University
- University of Iowa Hospitals & Clinics
- Wichita Nephrology Group Pa
- Tulane Medical Center (TMC) - Tulane Lakeside Specialty Clinic
- Omega Clinical Research Center
- MedStar Health Research Institute
- Harvard Medical School - Joslin Diabetes Center and Joslin Clinic (JDC)
- University of Michigan Health System (UMHS) - Metabolism Endocrinology & Diabetes Clinic (MEND) at Domino's Farms
- University of Missouri Health Care
- Washington University School of Medicine in St. Louis
- Cleveland Clinic - Main Campus
- University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne
- Physicians East, P.A. - Endocrinology
- Carolina Health Specialists - Medical Complex - 82nd Parkway Location
- University of Texas Health San Antonio
- Consano Clinical Research, LLC.
- Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center
- Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane
- Alberta Health Services (AHS) - Richmond Road Diagnostic and Treatment Centre (RRDTC)
- Alberta Diabetes Institute Clinical Research Unit
- Centre de Recherche Clinique de Laval (CRCL)
- McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
- Toronto General Hospital - University Health Network, Renal Physiology laboratory
- Zhongshan People's Hospital
- The 4th Affiliated Hospital of Harbin Medical University
- The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
- Affiliated Hospital of Jiangsu University
- Shanxi Bethune Hospital
- Peking University People's Hospital
- Southern Medical University - Nanfang Hospital (Southern Hospital)
- Nanjing Medical University (NMU) - Huai'an First People's Hospital
- Nanjing Medical University (NMU) - The Second Affiliated Hospital
- Fudan University - Shanghai Minhang District Central Hospital
- Zhongshan Hospital Fudan University, Qingpu Branch
- Aalborg Universitetshospital
- Sydvestjysk Sygehus - Esbjerg
- Steno Diabetes Center Copenhagen
- Regionshospitalet Gødstrup
- Nordsjaellands Hospital - Hillerod
- Odense Universitetshospital, Endokrinologisk Afd. M
- InnoDiab Forschung GmbH
- Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
- A.O.U. di Bologna Policlinico S.Orsola Malpighi
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- A.O.U. Careggi
- ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)
- Azienda Sanitaria Locale TO 5 - Ospedale Maggiore Chieri
- Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia
- Ospedale FBF e Oftalmico Milano
- Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
- ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario
- Seoul National University Hospital
- Korea University Anam Hospital
- Asan Medical Center
- Severance Hospital, Yonsei University Health System
- Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
- Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
- Hospital Vithas Sevilla | Endocrinology Department
- Hospital Gregorio Maranon | Endocrinology Department
- Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
- Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
- North Bristol NHS Trust - Southmead Hospital
- University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
- NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
- Royal London Hospital
- Wythenshawe Hospital
- Walsall Healthcare NHS Trust - Manor Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Finerenone arm
Placebo arm
Arm Description
Participants with eGFR ≥25 to <60 mL/min/1.73 m^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
Participants will take Finerenone matching placebo for 6 months.
Outcomes
Primary Outcome Measures
Change in Urinary albumin-to-creatinine ratio (UACR)
UACR will be assessed by the Central laboratory.
Secondary Outcome Measures
Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
Number of participants with Hyperkalaemia
Hyperkalemia will be an adverse events of special interest (AESI).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05901831
Brief Title
A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
Acronym
FINE-ONE
Official Title
A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Addition to Standard of Care, in Participants With Chronic Kidney Disease and Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 18, 2024 (Anticipated)
Primary Completion Date
October 2, 2025 (Anticipated)
Study Completion Date
October 2, 2025 (Anticipated)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes.
In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes.
The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes.
In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured.
Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with:
medical problems (also called treatment-emergent adverse events (TEAEs))
serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important
higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines.
The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times.
The study team will:
collect blood and urine samples
check the participants' vital signs such as blood pressure and heart rate
do a physical examination including height and weight
check the participants' heart health by using an electrocardiogram (ECG)
do pregnancy tests in women of childbearing potential
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Finerenone arm
Arm Type
Experimental
Arm Description
Participants with eGFR ≥25 to <60 mL/min/1.73 m^2 at Screening visit will take Finerenone Dose A. Participants with eGFR ≥60 mL/min/1.73 m^2 at Screening visit will take Dose B. Up-titration and down-titration of study intervention will be based on local potassium and kidney function (eGFR) values. Treatment duration is 6 months.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Participants will take Finerenone matching placebo for 6 months.
Intervention Type
Drug
Intervention Name(s)
Finerenone
Intervention Description
Dose A, Dose B, oral
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change in Urinary albumin-to-creatinine ratio (UACR)
Description
UACR will be assessed by the Central laboratory.
Time Frame
From baseline up to 6 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs)
Time Frame
From baseline up to 7 months
Title
Number of participants with Hyperkalaemia
Description
Hyperkalemia will be an adverse events of special interest (AESI).
Time Frame
From baseline up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
Participants with Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin, started within one year from diagnosis.
If the onset was after age 35, documentation of the presence of one or more of the following:
Circulating T1D-associated autoantibodies
Hospitalization for diabetic ketoacidosis
Plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dl).
HbA1c at Screening <10% (central assessment).
Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid.
K+ ≤ 4.8 mmol/L at Screening (local assessment)
Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment):
eGFR ≥25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit
UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements)
Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment.
Exclusion Criteria:
Participant with T2D (Type 2 diabetes).
Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs).
Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 (Glucagon-like peptide-1) receptor agonist.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bayer Clinical Trials Contact
Phone
(+)1-888-84 22937
Email
clinical-trials-contact@bayer.com
Facility Information:
Facility Name
Stanford Health Care (SHC)
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2200
Country
United States
Facility Name
Touro University (TU) - College of Osteopathic Medicine (TUCOM) - California
City
Vallejo
State/Province
California
ZIP/Postal Code
94592-1118
Country
United States
Facility Name
University of Colorado School of Medicine - Barbara Davis Center for Childhood Diabetes (BDC)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2536
Country
United States
Facility Name
Christiana Care Health System (Services)
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University of Miami Leonard M. Miller School of Medicine (UMMSM) - Peggy and Harold Katz Family Drug Discovery Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1013
Country
United States
Facility Name
Elixia Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Hanson Clinical Research Center, Inc.
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952-6722
Country
United States
Facility Name
Jedidiah Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Metabolic Research Institute, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401-3430
Country
United States
Facility Name
Morehouse School of Medicine | Clinical Research Centre
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303-3031
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Wichita Nephrology Group Pa
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tulane Medical Center (TMC) - Tulane Lakeside Specialty Clinic
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001-1210
Country
United States
Facility Name
Omega Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
MedStar Health Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Harvard Medical School - Joslin Diabetes Center and Joslin Clinic (JDC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5306
Country
United States
Facility Name
University of Michigan Health System (UMHS) - Metabolism Endocrinology & Diabetes Clinic (MEND) at Domino's Farms
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105-9484
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Cleveland Clinic - Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
University of North Carolina (UNC) - Hospitals Outpatient Center at Eastowne
City
Chapel Hill
State/Province
South Carolina
ZIP/Postal Code
27514-2286
Country
United States
Facility Name
Physicians East, P.A. - Endocrinology
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
27834-5051
Country
United States
Facility Name
Carolina Health Specialists - Medical Complex - 82nd Parkway Location
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572-4610
Country
United States
Facility Name
University of Texas Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Consano Clinical Research, LLC.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
79231
Country
United States
Facility Name
Eastern Virginia Medical School (EVMS) - Strelitz Diabetes Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Facility Name
Providence Medical Group - Spokane Nephrology - Providence Kidney Care Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-2318
Country
United States
Facility Name
Alberta Health Services (AHS) - Richmond Road Diagnostic and Treatment Centre (RRDTC)
City
Calgary
ZIP/Postal Code
T2T 5C7
Country
Canada
Facility Name
Alberta Diabetes Institute Clinical Research Unit
City
Edmonton
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Centre de Recherche Clinique de Laval (CRCL)
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM)
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Toronto General Hospital - University Health Network, Renal Physiology laboratory
City
Toronto
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Zhongshan People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528499
Country
China
Facility Name
The 4th Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The Central Hospital of Wuhan, Tongji Medl Collg Huazhong...
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
JiangSu
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030032
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Southern Medical University - Nanfang Hospital (Southern Hospital)
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Nanjing Medical University (NMU) - Huai'an First People's Hospital
City
Huai An
ZIP/Postal Code
223300
Country
China
Facility Name
Nanjing Medical University (NMU) - The Second Affiliated Hospital
City
Nanjing
ZIP/Postal Code
210011
Country
China
Facility Name
Fudan University - Shanghai Minhang District Central Hospital
City
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
Zhongshan Hospital Fudan University, Qingpu Branch
City
Shanghai
ZIP/Postal Code
201700
Country
China
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Sydvestjysk Sygehus - Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Steno Diabetes Center Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Regionshospitalet Gødstrup
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Nordsjaellands Hospital - Hillerod
City
Hillerod
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Odense Universitetshospital, Endokrinologisk Afd. M
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
InnoDiab Forschung GmbH
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Ruhr-Universitaet Bochum - Herz und Diabeteszentrum NRW (Heart and Diabetes Center)
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII)
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Sanitaria Locale TO 5 - Ospedale Maggiore Chieri
City
Chieri
ZIP/Postal Code
10023
Country
Italy
Facility Name
Università degli Studi "G. D'Annunzio" Chieti - Endocrinologia
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ospedale FBF e Oftalmico Milano
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario
City
Milan
ZIP/Postal Code
20142
Country
Italy
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
Seongbuk
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
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
Hospital Clinic de Barcelona | Instituto Clinic de Enfermedades Digestivas y Metabolicas - Endocrinologia y Nutricion
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Vithas Sevilla | Endocrinology Department
City
Castilleja de la Cuesta
ZIP/Postal Code
41950
Country
Spain
Facility Name
Hospital Gregorio Maranon | Endocrinology Department
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
North Bristol NHS Trust - Southmead Hospital
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde (NHSGGC) - Glasgow Royal Infirmary (GRI)
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Walsall Healthcare NHS Trust - Manor Hospital
City
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
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/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
URL
https://clinicaltrials.bayer.com/study/22267
Description
Click here to find further information and, after study completion, the study results according to Bayer's transparency standards
Learn more about this trial
A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
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