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CONFIDENCE: 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

Sponsor
Bayer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05254002
Collaborator
(none)
807
Enrollment
131
Locations
3
Arms
18.7
Anticipated Duration (Months)
6.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
807 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 23, 2022
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jan 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Finerenone and empagliflozin

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

Drug: Finerenone (Kerendia, BAY94-8862 )
oral administration, once daily

Drug: Empagliflozin
oral administration, once daily
Experimental: Finerenone and empagliflozin placebo

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

Drug: Finerenone (Kerendia, BAY94-8862 )
oral administration, once daily

Drug: Placebo
oral administration, once daily
Other Names:
  • Placebo to finerenone, and placebo to empagliflozin

    		•
    Experimental: Empagliflozin and finerenone placebo

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

    Drug: Empagliflozin
    oral administration, once daily

    Drug: Placebo
    oral administration, once daily
    Other Names:
  • Placebo to finerenone, and placebo to empagliflozin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone [Up to 180 days]

      Urinary albumin to-creatinine ratio (UACR)

    2. Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone [Up to 180 days]

    Secondary Outcome Measures

    1. Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210) [Up to 210 days]

    2. Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1) [Up to 210 days]

    3. Relative change in UACR category (>30%, >40%, >50%) at 180 days [Up to 180 days]

    4. Ratio of change from baseline in eGFR at 30 days [Up to 30 days]

      estimated glomerular filtration rate (eGRF)

    5. eGFR decline greater than 30% at 30 days from baseline [Up to 30 days]

    6. Ratio of change in eGFR at 180 days and 210 days from Day 30 [Up to 210 days]

    7. Number of participants with of acute kidney injury (AKI) events [Up to 180 days]

      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

    8. Total number of AKI events [Up to 180 days]

    9. Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]) [Up to 180 days]

      serum/plasma potassium (k+)

    10. Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]) [Up to 180 days]

    11. Relative change from baseline in K+ [Up to 180 days]

    12. Number of participants with severe hypoglycemia events [Up to 180 days]

      Severe hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).

    13. Total number of events of severe hypoglycemia events [Up to 180 days]

    14. Number of participants with symptomatic hypotension events [Up to 180 days]

    15. Total number of symptomatic hypotension events [Up to 180 days]

    16. Number of participants with genital mycotic events [Up to 180 days]

    17. Total number of genital mycotic events [Up to 180 days]

    18. Number of participants with ketoacidosis events [Up to 180 days]

    19. Total number of ketoacidosis events [Up to 180 days]

    20. Number of participants with necrotizing fasciitis of the perineum events [Up to 180 days]

    21. Total number of necrotizing fasciitis of the perineum events [Up to 180 days]

    22. Number of participants with urosepsis and pyelonephritis events [Up to 180 days]

    23. Total number of urosepsis and pyelonephritis events [Up to 180 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

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

    • In Part A: eGFR 40-90 ml/min/1.73m2 (with no more than 20% having an eGFR >75 ml/min/1.73m2) 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/1.73m2 (with no more than 20% having an eGFR >75 ml/min/1.73m2) 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Desert Clinical Research - CCT Research Mesa Arizona United States 85213
    2 Academic Medical Research Institute Los Angeles California United States 90022
    3 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    4 Emory University School of Medicine Atlanta Georgia United States 30303
    5 Meridian Clinical Research- Savannah Savannah Georgia United States 31406
    6 Cook County Health and Hospital System Chicago Illinois United States 60612
    7 Versailles Family Medicine Versailles Kentucky United States 40383
    8 Omega Clinical Research Center Metairie Louisiana United States 70006
    9 Clinical Research Consultants Kansas City Missouri United States 64111
    10 Kansas City VA Medical Center Kansas City Missouri United States 64128
    11 Washington University School of Medicine Saint Louis Missouri United States 63110
    12 St. Louis Heart & Vascular, PC Saint Louis Missouri United States 63136
    13 Somnos Clinical Research Lincoln Nebraska United States 68510
    14 Meridian Clinical Research- Norfolk Norfolk Nebraska United States 68701
    15 Healor Primary Care / CCT Research Las Vegas Nevada United States 89102
    16 Santa Rosa Medical Centers of Nevada / CCT Research Las Vegas Nevada United States 89119
    17 Circuit Clinical/Crystal Run Middletown New York United States 10941
    18 Randolph Medical Associates Asheboro North Carolina United States 27203
    19 University of North Carolina Kidney Center Chapel Hill North Carolina United States 27599-7155
    20 Eastern Nephrology Associates / Greenville NC Greenville North Carolina United States 27834
    21 Eastern Nephrology Associates Kinston North Carolina United States 28504
    22 Velocity Clinical Research, Cincinnati Cincinnati Ohio United States 45242
    23 University of Tennessee Health Science Center Memphis Tennessee United States 38163
    24 Office of Osvaldo A. Brusco, MD Corpus Christi Texas United States 78414
    25 DaVita Clinical Research El Paso Texas United States 79935
    26 Clinical Advancement Center, PLLC San Antonio Texas United States 78212
    27 University of Texas Health Science Center San Antonio Texas United States 78229-3900
    28 Olympus Family Medicine Salt Lake City Utah United States 84117
    29 Salem VA Medical Center Salem Virginia United States 24153
    30 MultiCare Rockwood Clinic Diabetes & Endocrinology Center Spokane Washington United States 99202
    31 CHU de Charleroi Hôpital civil Lodelinsart Hainaut Belgium 6042
    32 UZ Antwerpen Edegem Belgium 2650
    33 AZ St-Lucas Campus St-Lucas Gent Belgium 9000
    34 UZ Gent Gent Belgium 9000
    35 Regionaal ZH Jan Yperman Campus Mariaziekenhuis Ieper Belgium 8900
    36 AZ Groeninge Campus Kennedylaan Kortrijk Belgium 8500
    37 UZ Leuven Gasthuisberg Leuven Belgium 3000
    38 AZ Delta Roeselare Belgium 8800
    39 LMC Manna Research - Calgary Calgary Alberta Canada T2H 2G4
    40 LMC Manna Research - Barrie Barrie Ontario Canada L4N 7L3
    41 LMC Manna Research - Brampton Brampton Ontario Canada L6S 0C6
    42 LMC Manna Research - Thornhill Concord Ontario Canada L4K 4M2
    43 LMC Manna Research - Etobicoke Etobicoke Ontario Canada M9R 4E1
    44 Hamilton Medical Research Group Hamilton Ontario Canada L8M 1K7
    45 LMC Manna Research - Ottawa Nepean Ontario Canada K2J 0V2
    46 Bluewater Clinical Research Group Sarnia Ontario Canada N7T 4X3
    47 LMC Manna Research - Bayview Toronto Ontario Canada M4G 3E8
    48 Sameh Fikry Professional Corporation Waterloo Ontario Canada N2J 1C4
    49 LMC-Manna recherche Mirabel Mirabel Quebec Canada J7J 2K8
    50 Recherche GCP Research Montreal Quebec Canada H1M 1B1
    51 Centre Hospitalier de l'Université de Montréal (CHUM) Montréal Quebec Canada H2X 1P1
    52 LMC Clinical Research Inc. Montreal Ville Saint-Laurent Quebec Canada H4T 1Z9
    53 Sydvestjysk Sygehus Esbjerg Esbjerg Denmark 6700
    54 Steno Diabetes Center Copenhagen Herlev Denmark 2730
    55 Holstebro Hospital, Endocrinology dept. Holstebro Denmark 7500
    56 Bispebjerg Hospital København NV Denmark 2400
    57 Hôpital François Mitterrand - Dijon Dijon France 21000
    58 Center Hospitalier Michallon - Grenoble La Tronche France 38700
    59 Hôpital Edouard Herriot - Lyon Cedex Lyon Cedex France 69437
    60 Many Locations Multiple Locations France
    61 Hopital Carémeau - Nîmes NIMES cedex 9 France 30029
    62 Hôpital Saint Joseph Paris France 75014
    63 St. Josefskrankenhaus Heidelberg Baden-Württemberg Germany 69115
    64 ClinPhenomics GmbH&Co. KG Frankfurt Hessen Germany 60596
    65 Diabetologische Schwerpunkt Praxis Dortmund Dortmund Nordrhein-Westfalen Germany 44137
    66 Zentrum für Diabetologie und Ernährungsmedizin Ludwigshafen Rheinland-Pfalz Germany 67059
    67 Cardiologicum Pirna / Dresden-Seidnitz Pirna Sachsen Germany 01796
    68 Friedrich-Schiller-Uni. Jena Jena Thüringen Germany 07740
    69 Charité Campus Benjamin Franklin (CBF) Berlin Germany 12203
    70 Diabetes Zentrum Wandsbek Hamburg Germany 22041
    71 Clalit Health Services through HaEmek Medical Center Afula Israel 1834111
    72 Barzilai Medical Center Ashkelon Israel 7830604
    73 Edith Wolfson Medical Center Holon Israel 5822012
    74 Health Corporation of Galilee Medical Center Nahariya Israel 2210001
    75 Clalit Health Services Rabin Medical Center-Beilinson Campus Petach Tikva Israel 4941492
    76 DMC - Diabetes Medical Center Tel Aviv Israel 6937947
    77 Health Corporation of the Ziv Medical Center (R.A.) Zefat Israel 1311001
    78 A.O.U. di Parma Parma Emilia-Romagna Italy 43126
    79 ASL 4 Chiavarese Genova Liguria Italy 16043
    80 ASST Papa Giovanni XXIII Bergamo Lombardia Italy 24127
    81 ASST Rhodense Milano Lombardia Italy 20024
    82 Ospedale San Raffaele s.r.l. Milano Lombardia Italy 20132
    83 ASST Santi Paolo e Carlo Milano Lombardia Italy 20142
    84 A.O.U. San Luigi Gonzaga Torino Piemonte Italy 10043
    85 IRCCS Casa Sollievo della Sofferenza Foggia Puglia Italy 71013
    86 ATS Sardegna - ASSL Olbia Sassari Sardegna Italy 07026
    87 ASP di Catania Catania Sicilia Italy 95124
    88 A.O.U. Pisana Pisa Toscana Italy 56124
    89 A.O.U.I. Verona Verona Veneto Italy 37126
    90 Many Locations Multiple Locations Italy
    91 Saiseikai Matsuyama Hospital Matsuyama Ehime Japan 791-8026
    92 Fukuoka University Chikushi Hospital Chikushino Fukuoka Japan 818-8502
    93 Kokura Memorial Hospital Kitakyushu Fukuoka Japan 802-8555
    94 Hirohata Naika Clinic Kitakyushu Fukuoka Japan 807-0857
    95 Naka Kinen Clinic Naka Ibaraki Japan 311-0113
    96 Fukui-ken Saiseikai Hospital Fukui Japan 918-8503
    97 Fukuoka Wajiro Hospital Fukuoka Japan 811-0213
    98 Japanese Red Cross Kumamoto Hospital Kumamoto Japan 861-8520
    99 Many Locations Multiple Locations Japan
    100 Kyosokai AMC NISHI-UMEDA Clinic Osaka Japan 530-0001
    101 Osaka General Medical Center Osaka Japan 558-8558
    102 Yonsei University Wonju Christian Hospital Wonju Gang''weondo Korea, Republic of 26426
    103 Hallym University Sacred Heart Hospital Anyang-si Gyeonggido Korea, Republic of 14068
    104 Seoul National University Hospital Seoul Seoul Teugbyeolsi Korea, Republic of 03080
    105 Chung Nam National University Hospital Daejeon Korea, Republic of 35015
    106 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    107 Asan Medical Center Seoul Korea, Republic of 05505
    108 Meander Medisch Centrum Amersfoort Netherlands 3818 TZ
    109 OLVG - locatie Oost Amsterdam Netherlands 1091 AC
    110 Academisch Medisch Centrum (AMC) Amsterdam Netherlands 1105 AZ
    111 Gelre Ziekenhuizen Apeldoorn Netherlands 7334 DZ
    112 Albert Schweitzer Ziekenhuis, Locatie Dordwijk Dordrecht Netherlands 3318 AT
    113 Complexo Hospitalario Universitario de Ferrol Ferrol A Coruña Spain 15405
    114 Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela A Coruña Spain 15706
    115 Hospital SAS de Jerez de la Frontera Jerez de la Frontera Cádiz Spain 11407
    116 Hospital Principe de Asturias Alcalá de Henares Madrid Spain 28805
    117 Complejo Hospitalario Universitario A Coruña A Coruña Spain 15006
    118 Hospital Quirón Barcelona Spain 08023
    119 Hospital Universitario Virgen de las Nieves Granada Spain 18012
    120 Hospital Universitario 12 de Octubre Madrid Spain 28041
    121 Many Locations Multiple Locations Spain
    122 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    123 Changhua Christian Hospital Changhua Taiwan 50006
    124 Chang Gung Memorial Hospital Kaohsiung Kaohsiung Taiwan 833
    125 Many Locations Multiple Locations Taiwan
    126 Taipei Medical University - Shuang Ho Hospital New Taipei City, Taiwan 23561
    127 Far Eastern Memorial Hospital New Taipei City Taiwan 220
    128 China Medical University Hospital Taichung Taiwan 40447
    129 Taichung Veterans General Hospital Taichung Taiwan 40705
    130 National Taiwan University Hospital Taipei Taiwan 100
    131 Taipei Veterans General Hospital Taipei Taiwan 11217

    Sponsors and Collaborators

    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT05254002
    Other Study ID Numbers:
    • 21839
    • 2021-003037-11
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Empagliflozin

    Study Results

    No Results Posted as of Aug 16, 2022