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A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes (CONFIDENCE)

Primary Purpose

Type 2 Diabetes Mellitus, Chronic Kidney Disease

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

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria:

  • Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:

    • In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
    • In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
    • 300 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
  • Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%.
  • Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.

Exclusion Criteria:

  • Participants with type 1 diabetes (T1D).
  • Participant with hepatic insufficiency classified as Child-Pugh C.
  • Participant with blood pressure at Day 1 visit higher than 160/100 or systolic blood pressure lower than 90 mmHg.
  • Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
  • Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.
  • Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
  • Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.

Sites / Locations

  • Desert Clinical Research - CCT Research
  • Academic Medical Research InstituteRecruiting
  • Chase Medical Research, LLC
  • Emory University School of MedicineRecruiting
  • Meridian Clinical Research- SavannahRecruiting
  • Cook County Health and Hospital System
  • Versailles Family Medicine
  • Omega Clinical Research CenterRecruiting
  • Clinical Research ConsultantsRecruiting
  • Kansas City VA Medical CenterRecruiting
  • Washington University School of Medicine
  • St. Louis Heart & Vascular, PCRecruiting
  • Somnos Clinical ResearchRecruiting
  • Meridian Clinical Research- Norfolk
  • Healor Primary Care / CCT ResearchRecruiting
  • Santa Rosa Medical Centers of Nevada / CCT ResearchRecruiting
  • Circuit Clinical/Crystal RunRecruiting
  • Carolina Clinical Research & Consulting at Triad Internal MedicineRecruiting
  • University of North Carolina Kidney CenterRecruiting
  • Eastern Nephrology Associates / Greenville NCRecruiting
  • Blue Sky, MD/ Lamond Family MedicineRecruiting
  • Eastern Nephrology Associates - KinstonRecruiting
  • Velocity Clinical Research, CincinnatiRecruiting
  • Cleveland Clinic Foundation
  • University of Tennessee Health Science CenterRecruiting
  • Office of Osvaldo A. Brusco, MDRecruiting
  • DaVita Clinical Research - TexasRecruiting
  • Biopharma Informatic, LLCRecruiting
  • Clinical Advancement Center, PLLCRecruiting
  • University of Texas Health Science Center
  • Olympus Family Medicine
  • Salem VA Medical CenterRecruiting
  • MultiCare Rockwood Clinic Diabetes & Endocrinology Center
  • CHU de Charleroi Hôpital civil
  • UZ Antwerpen
  • AZ St-Lucas Campus St-Lucas
  • UZ GentRecruiting
  • Regionaal ZH Jan Yperman Campus MariaziekenhuisRecruiting
  • AZ Groeninge Campus KennedylaanRecruiting
  • UZ Leuven GasthuisbergRecruiting
  • AZ DeltaRecruiting
  • LMC Manna Research - Calgary
  • LMC Manna Research - Barrie
  • LMC Manna Research - Brampton
  • LMC Manna Research - Thornhill
  • LMC Manna Research - Etobicoke
  • Hamilton Medical Research GroupRecruiting
  • LMC Manna Research - Ottawa
  • Bluewater Clinical Research GroupRecruiting
  • LMC Manna Research - Bayview
  • Sameh Fikry Professional CorporationRecruiting
  • Clinical Research Solutions incRecruiting
  • Centricity Research Mirabel Multispecialty
  • Recherche GCP ResearchRecruiting
  • Centre Hospitalier de l'Université de Montréal (CHUM)
  • LMC Clinical Research Inc. MontrealRecruiting
  • Sydvestjysk Sygehus EsbjergRecruiting
  • Steno Diabetes Center CopenhagenRecruiting
  • Holstebro Hospital, Endocrinology dept.Recruiting
  • Bispebjerg HospitalRecruiting
  • Hôpital François Mitterrand - Dijon
  • Center Hospitalier Michallon - GrenobleRecruiting
  • Hôpital Edouard Herriot - Lyon CedexRecruiting
  • Many LocationsRecruiting
  • Hopital Carémeau - NîmesRecruiting
  • Hôpital Saint JosephRecruiting
  • St. Josefskrankenhaus
  • ClinPhenomics GmbH&Co. KGRecruiting
  • Diabetologische Schwerpunkt Praxis DortmundRecruiting
  • Zentrum für Diabetologie und ErnährungsmedizinRecruiting
  • Cardiologicum Pirna / Dresden-SeidnitzRecruiting
  • Friedrich-Schiller-Uni. JenaRecruiting
  • Charité Campus Benjamin Franklin (CBF)Recruiting
  • Diabetes Zentrum WandsbekRecruiting
  • King George Hospital
  • Indraprastha Apollo Hospital
  • KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
  • Eternal Hospital
  • G.S.V.M. Medical College
  • Institute of Post-Graduate Medical Education and Research
  • Mavani Dialysis & Kidney Center
  • Dr. Bantwal's Clinic
  • Bangalore Medical College & Research Institute
  • Government Kilpauk Medical College Hospital
  • Sriram Chandra Bhanj Medical College & Hospital
  • Nizam's Institute of Medical Sciences (NIMS)
  • Sawai Man Singh (SMS Hospital)
  • Government Medical College
  • Vinaya Hospital and Research Centre (A Unit of KIMS)
  • Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
  • Manipal Hospital
  • Asian Kidney Hospital and Medical Centre
  • Government Medical College and Hospital (GMCH) Nagpur
  • Grant Medical Foundation - Ruby Hall Clinic (RHC)
  • Lifepoint Multispecialty Hospital
  • Krishna Institute Of Medical Science
  • Osmania General Hospital
  • Vedanta Kidney Care
  • Clalit Health Services through HaEmek Medical CenterRecruiting
  • Barzilai Medical CenterRecruiting
  • Edith Wolfson Medical CenterRecruiting
  • Health Corporation of Galilee Medical CenterRecruiting
  • Clalit Health Services Rabin Medical Center-Beilinson Campus
  • DMC - Diabetes Medical Center
  • Health Corporation of the Ziv Medical Center (R.A.)Recruiting
  • A.O.U. di ParmaRecruiting
  • ASL 4 ChiavareseRecruiting
  • ASST Papa Giovanni XXIIIRecruiting
  • ASST RhodenseRecruiting
  • Ospedale San Raffaele s.r.l.Recruiting
  • ASST Santi Paolo e CarloRecruiting
  • A.O.U. San Luigi GonzagaRecruiting
  • IRCCS Casa Sollievo della SofferenzaRecruiting
  • ATS Sardegna - ASSL OlbiaRecruiting
  • ASP di Catania
  • A.O.U. Pisana
  • A.O.U.I. Verona
  • Many LocationsRecruiting
  • Saiseikai Matsuyama HospitalRecruiting
  • Fukuoka University Chikushi HospitalRecruiting
  • Kokura Memorial HospitalRecruiting
  • Hirohata Naika ClinicRecruiting
  • Nakakinen ClinicRecruiting
  • Fukui-ken Saiseikai HospitalRecruiting
  • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro HospitalRecruiting
  • Japanese Red Cross Kumamoto Hospital
  • Many LocationsRecruiting
  • Kyosokai AMC NISHI-UMEDA ClinicRecruiting
  • Osaka General Medical CenterRecruiting
  • Yonsei University Wonju Christian HospitalRecruiting
  • Hallym University Sacred Heart HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Chung Nam National University Hospital
  • Asan Medical CenterRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Meander Medisch Centrum
  • Onze Lieve Vrouwe GasthuisRecruiting
  • Academisch Medisch Centrum (AMC)
  • Gelre ZiekenhuizenRecruiting
  • Albert Schweitzer Ziekenhuis, DordwijkRecruiting
  • Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and NutritionRecruiting
  • Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión ArterialRecruiting
  • Hospital Clínico Universitario de Santiago de Compostela
  • Hospital SAS de Jerez de la Frontera
  • Hospital Principe de AsturiasRecruiting
  • Ciutat Sanitaria i Universitaria de la Vall d'HebronRecruiting
  • Hospital Quironsalud Barcelona | Internal Medicine DepartmentRecruiting
  • Hospital Vithas Sevilla | Endocrinology Department
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Clinico San Carlos
  • Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
  • Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
  • H. Costa del Sol (Marbella)
  • Many LocationsRecruiting
  • Hospital Clínico Universitario de ValenciaRecruiting
  • Hospital Universitario Dr. Peset
  • Changhua Christian HospitalRecruiting
  • Chang Gung Memorial Hospital KaohsiungRecruiting
  • Many LocationsRecruiting
  • Far Eastern Memorial Hospital | Nephrology DepartmentRecruiting
  • Taipei Medical University - Shuang Ho HospitalRecruiting
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Finerenone and empagliflozin

Finerenone and empagliflozin placebo

Empagliflozin and finerenone placebo

Arm Description

Participants will take finerenone and empagliflozin for up to 180 days.

Participants will take finerenone and placebo to empagliflozin for up to 180 days.

Participants will take empagliflozin and placebo to finerenone for up to 180 days.

Outcomes

Primary Outcome Measures

Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone
Urinary albumin to-creatinine ratio (UACR)
Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone

Secondary Outcome Measures

Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)
Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)
Relative change in UACR category (>30%, >40%, >50%) at 180 days
Ratio of change from baseline in eGFR at 30 days
estimated glomerular filtration rate (eGRF)
eGFR decline greater than 30% at 30 days from baseline
Ratio of change in eGFR at 180 days and 210 days from Day 30
Number of participants with of acute kidney injury (AKI) events
AKI is defined as any of the following: An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or A urine volume less than 0.5 ml/kg/h for 6 hours
Total number of AKI events
Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
serum/plasma potassium (k+)
Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
Relative change from baseline in K+
Number of participants with severe hypoglycemia events
Severe hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).
Total number of events of severe hypoglycemia events
Number of participants with symptomatic hypotension events
Total number of symptomatic hypotension events
Number of participants with genital mycotic events
Total number of genital mycotic events
Number of participants with ketoacidosis events
Total number of ketoacidosis events
Number of participants with necrotizing fasciitis of the perineum events
Total number of necrotizing fasciitis of the perineum events
Number of participants with urosepsis and pyelonephritis events
Total number of urosepsis and pyelonephritis events

Full Information

First Posted
February 4, 2022
Last Updated
October 4, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05254002
Brief Title
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
Acronym
CONFIDENCE
Official Title
A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin in Participants With Chronic Kidney Disease and Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
June 28, 2024 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD. Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine. In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone. Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D. 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, participants will visit the study site 7 times. The study team will: collect blood and urine samples check the participants' vital signs do a physical examination including height and weight check the participants' heart health by using an electrocardiogram (ECG) monitor the participants' blood pressure ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
807 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Finerenone and empagliflozin
Arm Type
Experimental
Arm Description
Participants will take finerenone and empagliflozin for up to 180 days.
Arm Title
Finerenone and empagliflozin placebo
Arm Type
Experimental
Arm Description
Participants will take finerenone and placebo to empagliflozin for up to 180 days.
Arm Title
Empagliflozin and finerenone placebo
Arm Type
Experimental
Arm Description
Participants will take empagliflozin and placebo to finerenone for up to 180 days.
Intervention Type
Drug
Intervention Name(s)
Finerenone (Kerendia, BAY94-8862 )
Intervention Description
oral administration, once daily
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
oral administration, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo to finerenone, and placebo to empagliflozin
Intervention Description
oral administration, once daily
Primary Outcome Measure Information:
Title
Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone
Description
Urinary albumin to-creatinine ratio (UACR)
Time Frame
Up to 180 days
Title
Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone
Time Frame
Up to 180 days
Secondary Outcome Measure Information:
Title
Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)
Time Frame
Up to 210 days
Title
Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)
Time Frame
Up to 210 days
Title
Relative change in UACR category (>30%, >40%, >50%) at 180 days
Time Frame
Up to 180 days
Title
Ratio of change from baseline in eGFR at 30 days
Description
estimated glomerular filtration rate (eGRF)
Time Frame
Up to 30 days
Title
eGFR decline greater than 30% at 30 days from baseline
Time Frame
Up to 30 days
Title
Ratio of change in eGFR at 180 days and 210 days from Day 30
Time Frame
Up to 210 days
Title
Number of participants with of acute kidney injury (AKI) events
Description
AKI is defined as any of the following: An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or A urine volume less than 0.5 ml/kg/h for 6 hours
Time Frame
Up to 180 days
Title
Total number of AKI events
Time Frame
Up to 180 days
Title
Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
Description
serum/plasma potassium (k+)
Time Frame
Up to 180 days
Title
Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
Time Frame
Up to 180 days
Title
Relative change from baseline in K+
Time Frame
Up to 180 days
Title
Number of participants with severe hypoglycemia events
Description
Severe hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).
Time Frame
Up to 180 days
Title
Total number of events of severe hypoglycemia events
Time Frame
Up to 180 days
Title
Number of participants with symptomatic hypotension events
Time Frame
Up to 180 days
Title
Total number of symptomatic hypotension events
Time Frame
Up to 180 days
Title
Number of participants with genital mycotic events
Time Frame
Up to 180 days
Title
Total number of genital mycotic events
Time Frame
Up to 180 days
Title
Number of participants with ketoacidosis events
Time Frame
Up to 180 days
Title
Total number of ketoacidosis events
Time Frame
Up to 180 days
Title
Number of participants with necrotizing fasciitis of the perineum events
Time Frame
Up to 180 days
Title
Total number of necrotizing fasciitis of the perineum events
Time Frame
Up to 180 days
Title
Number of participants with urosepsis and pyelonephritis events
Time Frame
Up to 180 days
Title
Total number of urosepsis and pyelonephritis events
Time Frame
Up to 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following: In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD. 300 ≤UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening <11%. Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit. Exclusion Criteria: Participants with type 1 diabetes (T1D). Participant with hepatic insufficiency classified as Child-Pugh C. Participant with blood pressure at Day 1 visit higher than 160/100 or systolic blood pressure lower than 90 mmHg. Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment. Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment. Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit. Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.
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
Desert Clinical Research - CCT Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Individual Site Status
Withdrawn
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Individual Site Status
Recruiting
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research- Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
Cook County Health and Hospital System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Withdrawn
Facility Name
Versailles Family Medicine
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Omega Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
St. Louis Heart & Vascular, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Recruiting
Facility Name
Somnos Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research- Norfolk
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Healor Primary Care / CCT Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Rosa Medical Centers of Nevada / CCT Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
Circuit Clinical/Crystal Run
City
Middletown
State/Province
New York
ZIP/Postal Code
10941
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Clinical Research & Consulting at Triad Internal Medicine
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Individual Site Status
Recruiting
Facility Name
University of North Carolina Kidney Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7155
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Nephrology Associates / Greenville NC
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Blue Sky, MD/ Lamond Family Medicine
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28792
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastern Nephrology Associates - Kinston
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28504
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research, Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Individual Site Status
Recruiting
Facility Name
Office of Osvaldo A. Brusco, MD
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414-4173
Country
United States
Individual Site Status
Recruiting
Facility Name
DaVita Clinical Research - Texas
City
El Paso
State/Province
Texas
ZIP/Postal Code
79935
Country
United States
Individual Site Status
Recruiting
Facility Name
Biopharma Informatic, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Individual Site Status
Withdrawn
Facility Name
Olympus Family Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Rockwood Clinic Diabetes & Endocrinology Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
CHU de Charleroi Hôpital civil
City
Lodelinsart
State/Province
Hainaut
ZIP/Postal Code
6042
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
AZ St-Lucas Campus St-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Regionaal ZH Jan Yperman Campus Mariaziekenhuis
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Groeninge Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
LMC Manna Research - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 2G4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
LMC Manna Research - Barrie
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4N 7L3
Country
Canada
Individual Site Status
Withdrawn
Facility Name
LMC Manna Research - Brampton
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0C6
Country
Canada
Individual Site Status
Withdrawn
Facility Name
LMC Manna Research - Thornhill
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
LMC Manna Research - Etobicoke
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Hamilton Medical Research Group
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Individual Site Status
Recruiting
Facility Name
LMC Manna Research - Ottawa
City
Nepean
State/Province
Ontario
ZIP/Postal Code
K2J 0V2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Bluewater Clinical Research Group
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
LMC Manna Research - Bayview
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Sameh Fikry Professional Corporation
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Research Solutions inc
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2TOC1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centricity Research Mirabel Multispecialty
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Recherche GCP Research
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
LMC Clinical Research Inc. Montreal
City
Ville Saint-Laurent
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sydvestjysk Sygehus Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Steno Diabetes Center Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Holstebro Hospital, Endocrinology dept.
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Bispebjerg Hospital
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hôpital François Mitterrand - Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Center Hospitalier Michallon - Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Edouard Herriot - Lyon Cedex
City
Lyon Cedex
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Carémeau - Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
St. Josefskrankenhaus
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
ClinPhenomics GmbH&Co. KG
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
Diabetologische Schwerpunkt Praxis Dortmund
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Zentrum für Diabetologie und Ernährungsmedizin
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Individual Site Status
Recruiting
Facility Name
Cardiologicum Pirna / Dresden-Seidnitz
City
Pirna
State/Province
Sachsen
ZIP/Postal Code
01796
Country
Germany
Individual Site Status
Recruiting
Facility Name
Friedrich-Schiller-Uni. Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07740
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Campus Benjamin Franklin (CBF)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Diabetes Zentrum Wandsbek
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Individual Site Status
Recruiting
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Indraprastha Apollo Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110076
Country
India
Individual Site Status
Not yet recruiting
Facility Name
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
City
Belagavi
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Eternal Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Individual Site Status
Not yet recruiting
Facility Name
G.S.V.M. Medical College
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208002
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Institute of Post-Graduate Medical Education and Research
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Mavani Dialysis & Kidney Center
City
Ahmedabad
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Dr. Bantwal's Clinic
City
Bengaluru
ZIP/Postal Code
560076
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Bangalore Medical College & Research Institute
City
Bengaluru
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Government Kilpauk Medical College Hospital
City
Chennai
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Sriram Chandra Bhanj Medical College & Hospital
City
Cuttack
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Nizam's Institute of Medical Sciences (NIMS)
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Sawai Man Singh (SMS Hospital)
City
Jaipur
ZIP/Postal Code
302001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Government Medical College
City
Kozhikode
ZIP/Postal Code
673008
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Vinaya Hospital and Research Centre (A Unit of KIMS)
City
Mangalore
ZIP/Postal Code
575003
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
City
Mumbai
ZIP/Postal Code
400 012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Manipal Hospital
City
Mysore
ZIP/Postal Code
5570015
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Asian Kidney Hospital and Medical Centre
City
Nagapur
ZIP/Postal Code
440010
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Government Medical College and Hospital (GMCH) Nagpur
City
Nagpur
ZIP/Postal Code
440009
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Grant Medical Foundation - Ruby Hall Clinic (RHC)
City
Pune
ZIP/Postal Code
411001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Lifepoint Multispecialty Hospital
City
Pune
ZIP/Postal Code
411057
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Krishna Institute Of Medical Science
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Osmania General Hospital
City
Telangana
ZIP/Postal Code
500012
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Vedanta Kidney Care
City
Vadodara
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Clalit Health Services through HaEmek Medical Center
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Individual Site Status
Recruiting
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Individual Site Status
Recruiting
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Individual Site Status
Recruiting
Facility Name
Health Corporation of Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Clalit Health Services Rabin Medical Center-Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
DMC - Diabetes Medical Center
City
Tel Aviv
ZIP/Postal Code
6937947
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Health Corporation of the Ziv Medical Center (R.A.)
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
Individual Site Status
Recruiting
Facility Name
A.O.U. di Parma
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASL 4 Chiavarese
City
Genova
State/Province
Liguria
ZIP/Postal Code
16043
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Rhodense
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20024
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele s.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Santi Paolo e Carlo
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. San Luigi Gonzaga
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Name
ATS Sardegna - ASSL Olbia
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07026
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASP di Catania
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Withdrawn
Facility Name
A.O.U. Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
A.O.U.I. Verona
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Italy
Individual Site Status
Recruiting
Facility Name
Saiseikai Matsuyama Hospital
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-8026
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hirohata Naika Clinic
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-0857
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakakinen Clinic
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukui-ken Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
City
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-8520
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyosokai AMC NISHI-UMEDA Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yonsei University Wonju Christian Hospital
City
Wonju
State/Province
Gang''weondo
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
State/Province
Gyeonggido
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chung Nam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3818 TZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Gelre Ziekenhuizen
City
Apeldoorn
ZIP/Postal Code
7334 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Albert Schweitzer Ziekenhuis, Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
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
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
City
Ferrol
State/Province
A Coruña
ZIP/Postal Code
15405
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital SAS de Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Principe de Asturias
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quironsalud Barcelona | Internal Medicine Department
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Vithas Sevilla | Endocrinology Department
City
Castilleja de la Cuesta
ZIP/Postal Code
41950
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
H. Costa del Sol (Marbella)
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital Kaohsiung
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Many Locations
City
Multiple Locations
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Far Eastern Memorial Hospital | Nephrology Department
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University - Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Withdrawn
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting

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.

Learn more about this trial

A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes

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