check_circleStudy Completed

Type 2 diabetes mellitus, Chronic kidney disease

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
     -- 100 ≤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.
  • - Participants with type 1 diabetes (T1D).
    - Participant with hepatic insufficiency classified as Child-Pugh C.
    - Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP 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 visit (central laboratory value).

Trial summary

Enrollment Goal
1664
Trial Dates
June 2022 - March 2025
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Italy
Recruiting
Many LocationsMany Locations, Taiwan
Completed
Velocity Clinical Research - SavannahSavannah, 31406, United States
Recruiting
Many LocationsMany Locations, Japan
Recruiting
Many LocationsMany Locations, France
Recruiting
Many LocationsMany Locations, Spain
Completed
Diabetologische Schwerpunkt Praxis DortmundDortmund, 44137, Germany
Completed
Zentrum für Diabetologie und ErnährungsmedizinLudwigshafen, 67059, Germany
Not yet recruiting
St. JosefskrankenhausHeidelberg, 69115, Germany
Completed
Diabetes Zentrum WandsbekHamburg, 22041, Germany
Completed
Cardiologicum Pirna / Dresden-SeidnitzPirna, 1796, Germany
Active, not recruiting
Charité Campus Benjamin Franklin (CBF)Berlin, 12203, Germany
Active, not recruiting
ClinPhenomics GmbH&Co. KGFrankfurt, 60596, Germany
Completed
Hopital Carémeau - NîmesNîmes, 30029, France
Completed
Center Hospitalier Michallon - GrenobleGRENOBLE CEDEX 9, 38043, France
Active, not recruiting
Hôpital François Mitterrand - DijonDijon, 21000, France
Completed
Hopital Carémeau - NîmesNîmes, 30029, France
Completed
Hôpital Edouard Herriot - Lyon CedexLYON CEDEX, 69003, France
Completed
Hôpital Saint JosephPARIS, 75014, France
Completed
Saiseikai Matsuyama HospitalMatsuyama, 791-8026, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Medical Corporation Taifukukai, Osaka Nishiumeda ClinicOsaka, 530-0001, Japan
Completed
Fukuoka University Chikushi HospitalChikushino, 818-8502, Japan
Not yet recruiting
Japanese Red Cross Kumamoto HospitalKumamoto, 861-8520, Japan
Completed
Naka Kinen ClinicNaka-shi, 311-0113, Japan
Completed
Kokura Memorial HospitalKitakyushu, 802-8555, Japan
Completed
Hirohata Naika ClinicKitakyushu, 807-0857, Japan
Completed
Fukui-ken Saiseikai HospitalFukui, 918-8503, Japan
Completed
Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro HospitalFukuoka, 811-0213, Japan
Completed
Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-MetabolicoMilano, 20132, Italy
Completed
Azienda Socio Sanitaria Locale N 2 Della Gallura - DiabetologiaOlbia, 07026, Italy
Completed
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e DiabetologiaBergamo, 24127, Italy
Completed
Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia DiabeticaMilano, 20142, Italy
Not yet recruiting
Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del MetabolismoVerona, 37134, Italy
Withdrawn
ASP di CataniaCatania, 95124, Italy
Completed
ASL 4 ChiavareseChiavari, 16043, Italy
Completed
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche DiabetologiaOrbassano, 10043, Italy
Completed
Azienda Socio Sanitaria Territoriale RhodenseRho, 20017, Italy
Completed
Azienda Ospedaliero Universitaria Parma - SC NefrologiaParma, 43126, Italy
Withdrawn
Hospital SAS de Jerez de la FronteraJerez de la Frontera, 11407, Spain
Completed
Hospital Quironsalud Barcelona | Internal Medicine DepartmentBarcelona, 8023, Spain
Withdrawn
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and NutritionA Coruna, 15006, Spain
Completed
Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y NutricionGranada, 18014, Spain
Completed
Hospital Principe de AsturiasAlcalá de Henares, 28805, Spain
Withdrawn
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Active, not recruiting
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión ArterialFerrol, 15405, Spain
Completed
UZ GentGENT, 9000, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Recruiting
Regionaal ZH Jan Yperman Campus MariaziekenhuisIEPER, 8900, Belgium
Completed
AZ Groeninge Campus KennedylaanKortrijk, 8500, Belgium
Recruiting
AZ DeltaROESELARE, 8800, Belgium
Not yet recruiting
CHU de Charleroi Hôpital civilLodelinsart, 6042, Belgium
Withdrawn
UZ AntwerpenEDEGEM, 2650, Belgium
Not yet recruiting
AZ St-Lucas Campus St-Lucasgent, 9000, Belgium
Completed
Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology DepartmentDORDRECHT, 3318 AT, Netherlands
Withdrawn
Academisch Medisch Centrum (AMC)AMSTERDAM, 1105 AZ, Netherlands
Completed
Gelre ZiekenhuizenAPELDOORN, 7334 DZ, Netherlands
Completed
Meander Medisch CentrumAMERSFOORT, 3818 TZ, Netherlands
Completed
Onze Lieve Vrouwe GasthuisAMSTERDAM, 1091 AC, Netherlands
Completed
Region Midtjylland | Regionshospitalet Godstrup - Nephrology DepartmentHerning, DK-7400, Denmark
Completed
Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research DepartmentHerlev, 2730, Denmark
Completed
Bispebjerg Hospital - HjerteafdelingKøbenhavn, DK-2400, Denmark
Completed
Hospital of South West Jutland | Department of Endocrinology ResearchEsbjerg, 6700, Denmark
Withdrawn
DMC - Diabetes Medical CenterTel Aviv, 6937947, Israel
Completed
Health Corporation of the Ziv Medical Center (R.A.)Zefat, 1311001, Israel
Completed
Barzilai Medical Center | Department of Nephrology and HypertensionAshkelon, 7830604, Israel
Completed
Health Corporation of Galilee Medical CenterNahariya, 2210001, Israel
Completed
HaEmek Medical Center | Internal Medicine C Department - Research UnitAfula, 1834111, Israel
Not yet recruiting
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetach Tikva, 4941492, Israel
Completed
Edith Wolfson Medical Center | Internal Medicine DepartmentHolon, 58100, Israel
Completed
Far Eastern Memorial Hospital | Nephrology DepartmentNew Taipei City, 220, Taiwan
Completed
Changhua Christian HospitalChanghua, 50006, Taiwan
Completed
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Completed
Taipei Medical University - Shuang Ho HospitalNew Taipei City, 23561, Taiwan
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
China Medical University HospitalTaichung, 404327, Taiwan
Withdrawn
National Taiwan University HospitalTaipei, 100, Taiwan
Completed
Friedrich-Schiller-Uni. JenaJena, 07747, Germany
Completed
Clinical Research ConsultantsKansas City, 64111, United States
Withdrawn
University of Texas Health Science CenterSan Antonio, 78229-3900, United States
Completed
Office of Osvaldo A. Brusco, MDCorpus Christi, 78414-4173, United States
Completed
Academic Medical Research InstituteLos Angeles, 90022, United States
Withdrawn
Cook County Health and Hospital SystemChicago, 60612, United States
Active, not recruiting
Kansas City VA Medical Center - EndocrinologyKansas City, 64128, United States
Not yet recruiting
Meridian Clinical Research- NorfolkNorfolk, 68701, United States
Active, not recruiting
DaVita Clinical Research- El PasoEl Paso, 79925, United States
Active, not recruiting
Circuit Clinical/Crystal RunMiddletown, 10941, United States
Completed
Salem VA Medical Center - EndocrinologySalem, 24153, United States
Completed
University of Tennessee Health Science CenterMemphis, 38163, United States
Completed
Randolph Medical AssociatesAsheboro, 27203, United States
Completed
Clinical Advancement Center, PLLCSan Antonio, 78212, United States
Active, not recruiting
Velocity Clinical Research, CincinnatiCincinnati, 45242, United States
Completed
St. Louis Heart & Vascular, PCSaint Louis, 63136, United States
Completed
Eastern Nephrology Associates - Greenville WestGreenville, 27834, United States
Completed
Washington University School of Medicine in St. LouisSaint Louis, 63110-1010, United States
Not yet recruiting
Chase Medical Research, LLCWaterbury, 06708, United States
Active, not recruiting
Somnos Clinical ResearchLincoln, 68510, United States
Completed
Omega Clinical Research CenterMetairie, 70006, United States
Completed
Grady Memorial Hospital - EndocrinologyAtlanta, 30303, United States
Active, not recruiting
Olympus Family MedicineSalt Lake City, 84117, United States
Active, not recruiting
Eastern Nephrology Associates - KinstonKinston, 28504, United States
Withdrawn
Desert Clinical Research - CCT ResearchMesa, 85213, United States
Active, not recruiting
Healor Primary Care / CCT ResearchLas Vegas, 89102, United States
Not yet recruiting
Versailles Family MedicineVersailles, 40383, United States
Completed
University of North Carolina Kidney CenterChapel Hill, 27599-7155, United States
Completed
Casa Sollievo della Sofferenza - EndocrinologiaSan Giovanni Rotondo, 71013, Italy
Completed
Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e DiabetologiaPisa, 56124, Italy
Active, not recruiting
Hamilton Medical Research GroupHamilton, L8M 1K7, Canada
Completed
Sameh Fikry Professional CorporationWaterloo, N2J 1C4, Canada
Withdrawn
Centricity Research Mirabel MultispecialtyMirabel, J7J 2K8, Canada
Completed
Recherche GCP ResearchMontreal, H2R 1V6, Canada
Withdrawn
LMC Manna Research - BayviewToronto, M4G 3E8, Canada
Withdrawn
LMC Manna Research - BramptonBrampton, L6S 0C6, Canada
Withdrawn
LMC Manna Research - ThornhillConcord, L4K 4M2, Canada
Withdrawn
LMC Manna Research - EtobicokeEtobicoke, M9R 4E1, Canada
Withdrawn
LMC Manna Research - BarrieTBC, L4N 7L3, Canada
Not yet recruiting
LMC Manna Research - CalgaryCalgary, T2H 2G4, Canada
Active, not recruiting
Centre Hospitalier de l’Université de Montréal (CHUM)Montreal, H2X 3E4, Canada
Active, not recruiting
Bluewater Clinical Research GroupSarnia, N7T 4X3, Canada
Completed
LMC Clinical Research Inc. MontrealVille Saint-Laurent, H4T 1Z9, Canada
Withdrawn
LMC Manna Research - OttawaNepean, K2J 0V2, Canada
Completed
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea,_republic_of
Completed
Asan Medical CenterSeoul, 05505, Korea,_republic_of
Completed
Yonsei University Wonju Christian HospitalWonju, 26426, Korea,_republic_of
Completed
Hallym University Sacred Heart HospitalAnyang-si, 14068, Korea,_republic_of
Not yet recruiting
Chung Nam National University HospitalDaejeon, 35015, Korea,_republic_of
Completed
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Completed
MultiCare Rockwood Clinic Diabetes & Endocrinology CenterSpokane, 99202, United States
Active, not recruiting
Santa Rosa Medical Centers of Nevada / CCT ResearchLas Vegas, 89119, United States
Withdrawn
Cleveland Clinic FoundationCleveland, 44195, United States
Completed
Biopharma Informatic - McAllen, TXMcAllen, 78503, United States
Completed
Hospital Universitario Dr. PesetValencia, 46017, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Active, not recruiting
Clinical Research Solutions, Inc.Waterloo, N2T 0C1, Canada
Active, not recruiting
Blue Sky, MD/ Lamond Family MedicineHendersonville, 28792, United States
Active, not recruiting
Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology DepartmentMajadahonda, 28222, Spain
Completed
Hospital Vithas Sevilla | Endocrinology DepartmentCastilleja de la Cuesta, 41950, Spain
Active, not recruiting
Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology DepartmentMalaga, 29010, Spain
Completed
Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)Madrid, 28040, Spain
Not yet recruiting
H. Costa del Sol (Marbella)Marbella, 29603, Spain
Not yet recruiting
Hospital Clinico San CarlosMadrid, 28040, Spain
Active, not recruiting
Eternal Heart Care Centre (EHCC) and Research InstituteJaipur, 302020, India
Active, not recruiting
Government Medical CollegeKozhikode, 673008, India
Active, not recruiting
Vinaya Hospital and Research Centre (A Unit of KIMS)Mangalore, 575003, India
Active, not recruiting
Sawami Man Singh (SMS) Medical College & Attached HospitalsJaipur, 302017, India
Active, not recruiting
Krishna Institute Of Medical ScienceSecunderabad, 500003, India
Active, not recruiting
Manipal HospitalMysore, 5570 015, India
Active, not recruiting
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research CentreBelgaum, 590010, India
Active, not recruiting
Institute of Post-Graduate Medical Education and ResearchKolkata, 700020, India
Not yet recruiting
Lifepoint Multispecialty HospitalPune, 411057, India
Active, not recruiting
Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) HospitalMumbai, 400 012, India
Active, not recruiting
G.S.V.M. Medical CollegeKanpur, 208002, India
Not yet recruiting
Dr. Bantwal's ClinicBengaluru, 560076, India
Not yet recruiting
Bangalore Medical College & Research InstituteBengaluru, NA, India
Active, not recruiting
Mavani Dialysis & Kidney CenterAhmedabad, NA, India
Not yet recruiting
Sriram Chandra Bhanj Medical College & HospitalCuttack, NA, India
Active, not recruiting
Vedanta Kidney CareVadodara, NA, India
Active, not recruiting
Government Kilpauk Medical College HospitalChennai, NA, India
Active, not recruiting
Indraprastha Apollo HospitalNew Delhi, 110076, India
Active, not recruiting
Osmania General HospitalTelangana, 500012, India
Not yet recruiting
Government Medical College and Hospital (GMCH) NagpurNagpur, 440009, India
Active, not recruiting
Grant Medical Foundation - Ruby Hall Clinic (RHC)Pune, 411001, India
Active, not recruiting
King George HospitalVisakhapatnam, NA, India
Active, not recruiting
Asian Kidney Hospital and Medical CentreNagapur, 440010, India
Active, not recruiting
Nizam's Institute of Medical Sciences (NIMS)Hyderabad, 500082, India
Completed
Dunes Clinical Research LLCDakota Dunes, 57049, United States
Completed
DarSalud Care / LifeDOC ResearchMemphis, 38119, United States
Withdrawn
Dr Nowreen Haq Endocrinology ClinicAnnapolis, 21401, United States
Completed
West Orange Endocrinology & Clinical ResearchOcoee, 34761-4547, United States
Completed
Innovative Research InstitutePort Charlotte, 33952, United States
Not yet recruiting
Victorium Clinical ResearchHouston, 77024-2593, United States
Withdrawn
East Coast Institute for Research, Inc. - JacksonvilleJacksonville, 32204, United States
Active, not recruiting
South Shore NephrologyPlymouth, 02360, United States
Completed
Global Kidney CenterHouston, 77008, United States
Completed
Oakland Medical CenterDakota Dunes, 48085, United States
Completed
Nola Care Clinical ResearchMetairie, 70006, United States
Completed
Thyroid, Endocrinology, and Diabetes (TED) PADallas, 75208-2362, United States
Completed
Lake Michigan NephrologySaint Joseph, 49085, United States
Active, not recruiting
North Texas Kidney Disease Associates, PLLCLewisville, 75057, United States
Completed
Florida Kidney Physicians - Delray Beach NephrologyDelray Beach, 33445, United States
Completed
Southeast Kidney AssociatesEast Point, 30344, United States
Completed
Touro University CaliforniaVallejo, 94592, United States
Completed
Northridge HospitalNorthridge, 91325, United States
Not yet recruiting
Olive View - UCLA Medical CenterSylmar, 91342-1437, United States
Withdrawn
Baliga Family PracticeColumbus, 31904, United States
Completed
Southwest Kidney Institute, PLCSurprise, 85374, United States
Withdrawn
Advent HealthOrlando, 32804, United States
Completed
Metabolic Research Institute, Inc.West Palm Beach, 33401-3430, United States
Active, not recruiting
University of Texas Health Science CenterSan Antonio, 78249, United States
Completed
Jiyugaoka Yamada Internal Medicine ClinicObihiro, 080-0848, Japan
Completed
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - EndocrinologiaMilano, 20122, Italy
Completed
Università degli Studi "G. D'Annunzio" di Chieti - EndocrinologiaChieti, 66100, Italy
Completed
William Osler Health centre, Sakuara MedicalMississauga, L5H4K9, Canada
Active, not recruiting
Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus AalstAalst, 9300, Belgium
Completed
Clalit Health | Soroka Medical Center - Internal Medicine DepartmentBeer Sheva, 8410101, Israel
Completed
Kyung Hee University Hospital at GangdongSeoul, 5278, Korea,_republic_of
Completed
Seoul National University Bundang HospitalSeongnam-si, 13620, Korea,_republic_of
Active, not recruiting
Hanyang University Guri HospitalGuri-si, 471-701, Korea,_republic_of
Completed
Hallym University Kangnam Sacred Heart HospitalSeoul, 7442, Korea,_republic_of
Completed
Korea University Ansan HospitalGyeonggi-do, 425-707, Korea,_republic_of
Completed
The Catholic University of Korea, Incheon St.Mary's HospitalIncheon, 21431, Korea,_republic_of
Completed
Public Central Hospital of Matto Ishikawa | Clinical Trial Management OfficeHakusan, 924-8588, Japan
Completed
Soon Chun Hyang University Cheonan HospitalCheonan, 31151, Korea,_republic_of
Completed
Hadassah University Medical Center (HUMC)Jerusalem, 911200, Israel
Not yet recruiting
Max Super Speciality Hospital (MSSH) - SaketNew Delhi, 110017, India
Not yet recruiting
All India Institute of Medical SciencesBhubaneswar, 751019, India
Withdrawn
Nephrology Associates Of Northern Illinois And Ind - Fort WayneFort Wayne, 46804, United States
Withdrawn
Nephrology Associates of Northern Illinois and Indiana (NANI) - HinsdaleHinsdale, 60521, United States

Primary Outcome

  • Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone
    Urinary albumin to-creatinine ratio (UACR)
    date_rangeTime Frame:
    Up to 180 days
  • Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone
    date_rangeTime Frame:
    Up to 180 days
  • Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone
    date_rangeTime Frame:
    Upto 180 days
  • Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone
    date_rangeTime Frame:
    Up to 180 days

Secondary Outcome

  • Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)
    date_rangeTime Frame:
    Up to 210 days
  • Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)
    date_rangeTime Frame:
    Up to 210 days
  • Relative change in UACR category (>30%, >40%, >50%) at 180 days
    date_rangeTime Frame:
    Up to 180 days
  • Ratio of change from baseline in eGFR at 30 days
    estimated glomerular filtration rate (eGRF)
    date_rangeTime Frame:
    Up to 30 days
  • eGFR decline greater than 30% at 30 days from baseline
    date_rangeTime Frame:
    Up to 30 days
  • Ratio of change in eGFR at 180 days and 210 days from Day 30
    date_rangeTime Frame:
    Up to 210 days
  • Proportion 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
    date_rangeTime Frame:
    Up to 180 days
  • Total number of AKI events
    date_rangeTime Frame:
    Up to 180 days
  • Proportion 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+)
    date_rangeTime Frame:
    Up to 180 days
  • Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
    date_rangeTime Frame:
    Up to 180 days
  • Change from baseline in K+
    date_rangeTime Frame:
    Up to 180 days
  • Proportion of participants with severe hypoglycemia events
    Severe hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).
    date_rangeTime Frame:
    Up to 180 days
  • Total number of events of severe hypoglycemia events
    date_rangeTime Frame:
    Up to 180 days
  • Proportion of participants with symptomatic hypotension events
    date_rangeTime Frame:
    Up to 180 days
  • Total number of symptomatic hypotension events
    date_rangeTime Frame:
    Up to 180 days
  • Proportion of participants with genital mycotic events
    date_rangeTime Frame:
    Up to 180 days
  • Total number of genital mycotic events
    date_rangeTime Frame:
    Up to 180 days
  • Proportion of participants with ketoacidosis events
    date_rangeTime Frame:
    Up to 180 days
  • Total number of ketoacidosis events
    date_rangeTime Frame:
    Up to 180 days
  • Proportion of participants with necrotizing fasciitis of the perineum events
    date_rangeTime Frame:
    Up to 180 days
  • Total number of necrotizing fasciitis of the perineum events
    date_rangeTime Frame:
    Up to 180 days
  • Proportion of participants with urosepsis and pyelonephritis events
    date_rangeTime Frame:
    Up to 180 days
  • Total number of urosepsis and pyelonephritis events
    date_rangeTime Frame:
    Up to 180 days

Trial design

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 alone in participants with chronic kidney disease and type 2 diabetes.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3