一项研究，旨在了解 Finerenone 和 Empagliflozin 联合治疗的效果如何，以及与单独使用每种治疗相比，它在患有长期肾脏疾病（慢性肾脏疾病）和 2 型糖尿病的成人参与者中的安全性如何 (CONFIDENCE)
2026年6月16日 更新者：Bayer
一项平行组治疗、2 期、双盲、三臂研究，以评估 Finerenone 加 Empagliflozin 与 Finerenone 或 Empagliflozin 在慢性肾脏病和 2 型糖尿病患者中的疗效和安全性
Finerenone 通过阻断一组称为盐皮质激素受体的蛋白质起作用。 已知盐皮质激素受体的刺激增加会引发肾脏损伤和炎症，因此被认为在 CKD 中起作用。
Empagliflozin 通过增加葡萄糖从血液排泄到尿液中来降低血糖水平。
在这项研究中，研究人员想了解与单独治疗相比，finerenone 和 empagliflozin 的组合如何有助于减缓参与者肾功能的恶化。 为此，将测量尿液中的蛋白质水平。 研究人员还想知道与单独治疗相比，这种组合的安全性如何。
根据治疗组的不同，参与者将服用 finerenone 和 empagliflozin 的组合，或 finerenone 与安慰剂一起服用，或 empagliflozin 与安慰剂一起服用，每天一次口服片剂。 安慰剂看起来像是一种治疗方法，但其中不含任何药物。 重要的是，参与者还将继续服用其他目前用于 CKD 和 T2D 的药物。
参与者将参与研究长达 7.5 个月，并将接受研究治疗 6 个月。 在研究期间，参与者将访问研究地点 7 次。
研究小组将：
- 收集血液和尿液样本
- 检查参与者的生命体征
- 进行身体检查，包括身高和体重
- 使用心电图 (ECG) 检查参与者的心脏健康
- 监测参与者的血压
- 向参与者询问他们的感受以及他们可能遇到的不良事件 不良事件是试验期间发生的任何问题。 医生会跟踪试验中发生的所有事件，即使他们认为这些事件可能与研究治疗无关。
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
1664
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Capital Region
-
Copenhagen、Capital Region、丹麦、2400
- Bispebjerg Hospital - Hjerteafdeling
-
Herlev、Capital Region、丹麦、2730
- Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
-
-
Central Jutland
-
Herning、Central Jutland、丹麦、7400
- Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
-
-
Region Syddanmark
-
Esbjerg、Region Syddanmark、丹麦、6700
- Hospital of South West Jutland | Department of Endocrinology Research
-
-
-
-
-
Afula、以色列、1834111
- HaEmek Medical Center | Internal Medicine C Department - Research Unit
-
Ashkelon、以色列、7830604
- Barzilai Medical Center | Department of Nephrology and Hypertension
-
Beersheba、以色列、8410101
- Clalit Health | Soroka Medical Center - Internal Medicine Department
-
Holon、以色列、5822012
- Edith Wolfson Medical Center | Internal Medicine Department
-
Jerusalem、以色列、911200
- Hadassah University Medical Center (HUMC)
-
Nahariya、以色列、2210001
- Health Corporation of Galilee Medical Center
-
Safed、以色列、1311001
- Health Corporation of the Ziv Medical Center (R.A.)
-
-
-
-
Ontario
-
Hamilton、Ontario、加拿大、L8M 1K7
- Hamilton Medical Research Group
-
Mississauga、Ontario、加拿大、L5H4K9
- William Osler Health centre, Sakuara Medical
-
Sarnia、Ontario、加拿大、N7T 4X3
- Bluewater Clinical Research Group
-
Waterloo、Ontario、加拿大、N2J 1C4
- Sameh Fikry Professional Corporation
-
Waterloo、Ontario、加拿大、N2T 0C1
- Clinical Research Solutions, Inc.
-
-
Quebec
-
Montreal、Quebec、加拿大、H1M 1B1
- GCP Research | Montreal
-
Montreal、Quebec、加拿大、H2X 0A9
- Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology
-
Saint-Laurent、Quebec、加拿大、H4T 1Z9
- LMC Clinical Research Inc. Montreal
-
-
-
-
-
Bengaluru、印度、560076
- Dr. Bantwal's Clinic
-
Bengaluru、印度
- Bangalore Medical College & Research Institute
-
Cuttack、印度
- Sriram Chandra Bhanj Medical College & Hospital
-
Nagpur、印度、440009
- Government Medical College and Hospital (GMCH) Nagpur
-
New Delhi、印度、110017
- Max Super Speciality Hospital (MSSH) - Saket
-
Pune、印度、411057
- Lifepoint Multispecialty Hospital
-
-
Andhra Pradesh
-
Visakhapatnam、Andhra Pradesh、印度、530002
- King George Hospital
-
-
Gujarat
-
Ahmedabad、Gujarat、印度、380052
- Mavani Dialysis & Kidney Center
-
Vadodara、Gujarat、印度、390007
- Vedanta Kidney Care
-
-
Karnataka
-
Belagavi、Karnataka、印度、590010
- K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
-
Mangalore、Karnataka、印度、575003
- Vinaya Hospital and Research Centre (A Unit of KIMS)
-
Mysore、Karnataka、印度、570015
- Manipal Hospital
-
-
Kerala
-
Kozhikode、Kerala、印度、673008
- Government Medical College
-
-
Maharashtra
-
Mumbai、Maharashtra、印度、400012
- Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
-
Nagpur、Maharashtra、印度、440010
- Asian Kidney Hospital And Medical Centre
-
Pune、Maharashtra、印度、411001
- Grant Medical Foundation - Ruby Hall Clinic (RHC)
-
-
National Capital Territory of Delhi
-
Bhubaneswar、National Capital Territory of Delhi、印度、751019
- All India Institute of Medical Sciences
-
New Delhi、National Capital Territory of Delhi、印度、110076
- Indraprastha Apollo Hospital
-
-
Rajasthan
-
Jaipur、Rajasthan、印度、302017
- Sawami Man Singh (SMS) Medical College & Attached Hospitals
-
Jaipur、Rajasthan、印度、302020
- Eternal Heart Care Centre (EHCC) and Research Institute
-
-
Tamil Nadu
-
Chennai、Tamil Nadu、印度、600010
- Government Kilpauk Medical College Hospital
-
-
Telangana
-
Hyderabad、Telangana、印度、500082
- Nizam's Institute of Medical Sciences (NIMS)
-
Secunderabad、Telangana、印度、500003
- Krishna Institute Of Medical Science
-
Telangana、Telangana、印度、500012
- Osmania General Hospital
-
-
Uttar Pradesh
-
Kanpur、Uttar Pradesh、印度、208002
- G.S.V.M. Medical College
-
-
West Bengal
-
Kolkata、West Bengal、印度、700020
- Institute of Post-Graduate Medical Education and Research
-
-
-
-
-
Many Locations、台湾
- Many locations
-
Taichung、台湾、404327
- China Medical University Hospital
-
-
Changhua
-
Changhua、Changhua、台湾、50006
- Changhua Christian Hospital
-
-
Kaohsiung
-
Kaohsiung City、Kaohsiung、台湾、833
- Chang Gung Memorial Hospital Kaohsiung
-
-
New Taipei
-
New Taipei City、New Taipei、台湾、220
- Far Eastern Memorial Hospital | Nephrology Department
-
New Taipei City、New Taipei、台湾、23561
- Taipei Medical University - Shuang Ho Hospital
-
-
Taichung
-
Taichung、Taichung、台湾、40705
- Taichung Veterans General Hospital
-
-
Taipei
-
Taipei、Taipei、台湾、11217
- Taipei Veterans General Hospital
-
-
-
-
Free and Hanseatic City of Hamburg
-
Hamburg、Free and Hanseatic City of Hamburg、德国、22041
- Diabetes Zentrum Wandsbek
-
-
Hesse
-
Frankfurt am Main、Hesse、德国、60596
- ClinPhenomics GmbH&Co. KG
-
-
North Rhine-Westphalia
-
Dortmund、North Rhine-Westphalia、德国、44137
- Diabetologische Schwerpunkt Praxis Dortmund
-
-
Rhineland-Palatinate
-
Ludwigshafen am Rhein、Rhineland-Palatinate、德国、67059
- Zentrum für Diabetologie und Ernährungsmedizin
-
-
Saxony
-
Pirna、Saxony、德国、1796
- Cardiologicum Pirna / Dresden-Seidnitz
-
-
State of Berlin
-
Berlin、State of Berlin、德国、12203
- Charité Campus Benjamin Franklin (CBF)
-
-
Thuringia
-
Jena、Thuringia、德国、7747
- Friedrich-Schiller-Uni. Jena
-
-
-
-
-
Chieti、意大利、66100
- Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
-
Many Locations、意大利
- Many locations
-
-
Apulia
-
San Giovanni Rotondo、Apulia、意大利、71013
- Casa Sollievo della Sofferenza - Endocrinologia
-
-
Emilia-Romagna
-
Parma、Emilia-Romagna、意大利、43126
- Azienda Ospedaliero Universitaria Parma - SC Nefrologia
-
-
Liguria
-
Chiavari、Liguria、意大利、16043
- ASL N 4 SSR Liguria_Ospedale di Chiavari - Diabetologia e Malattie Metaboliche
-
-
Lombardy
-
Bergamo、Lombardy、意大利、24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia
-
Milan、Lombardy、意大利、20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia
-
Milan、Lombardy、意大利、20132
- Ospedale San Raffaele S.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
-
Milan、Lombardy、意大利、20142
- Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica
-
Rho、Lombardy、意大利、20017
- Azienda Socio Sanitaria Territoriale Rhodense
-
-
Piedmont
-
Orbassano、Piedmont、意大利、10043
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia
-
-
Sardinia
-
Olbia、Sardinia、意大利、07026
- Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia
-
-
Tuscany
-
Pisa、Tuscany、意大利、56124
- Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia
-
-
-
-
-
Many Locations、日本
- Many locations
-
-
Ehime
-
Matsuyama、Ehime、日本、791-8026
- Saiseikai Matsuyama Hospital
-
-
Fukui
-
Fukui-shi、Fukui、日本、918-8503
- Fukui-ken Saiseikai Hospital
-
-
Fukuoka
-
Chikushino-shi、Fukuoka、日本、818-8502
- Fukuoka University Chikushi Hospital
-
Fukuoka、Fukuoka、日本、811-0213
- Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
-
Kitakyushu、Fukuoka、日本、802-8555
- Kokura Memorial Hospital
-
Kitakyushu、Fukuoka、日本、807-0857
- Hirohata Naika Clinic
-
-
Hokkaido
-
Obihiro、Hokkaido、日本、080-0848
- Jiyugaoka Yamada Internal Medicine Clinic
-
-
Ibaraki
-
Naka、Ibaraki、日本、311-0113
- Naka Kinen Clinic
-
-
Ishikawa-ken
-
Hakusan、Ishikawa-ken、日本、924-8588
- Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
-
-
Osaka
-
Osaka、Osaka、日本、558-8558
- Osaka General Medical Center
-
Osaka、Osaka、日本、530-0001
- Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
-
-
-
-
-
Ghent、比利时、9000
- UZ Gent
-
Ieper、比利时、8900
- Jan Yperman Ziekenhuis
-
Kortrijk、比利时、8500
- AZ Groeninge Campus Kennedylaan
-
Leuven、比利时、3000
- UZ Leuven Gasthuisberg
-
Roeselare、比利时、8800
- AZ Delta
-
-
Hainaut
-
Lodelinsart、Hainaut、比利时、6042
- CHU de Charleroi Hôpital civil
-
-
Oost-vlaanderen
-
Aalst、Oost-vlaanderen、比利时、9300
- Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
-
-
-
-
-
Many Locations、法国
- Many locations
-
-
Auvergne-Rhône-Alpes
-
La Tronche (Grenoble Area)、Auvergne-Rhône-Alpes、法国、38043
- Center Hospitalier Michallon - Grenoble
-
Lyon、Auvergne-Rhône-Alpes、法国、69003
- Hôpital Edouard Herriot - Lyon Cedex
-
-
Bourgogne-Franche-Comté
-
Dijon、Bourgogne-Franche-Comté、法国、21000
- CHU Dijon - Hopital Francois Miterrand
-
-
Occitanie
-
Nîmes、Occitanie、法国、30029
- Hopital Carémeau - Nîmes
-
-
Île-de-France Region
-
Paris、Île-de-France Region、法国、75014
- Hopital Saint Joseph
-
-
-
-
Arizona
-
Surprise、Arizona、美国、85374
- Southwest Kidney Institute, PLC - Suprise
-
-
California
-
Los Angeles、California、美国、90022
- Academic Medical Research Institute
-
Northridge、California、美国、91325
- Dignity Health Northridge Hospital Medical Center - Nephrology
-
Sylmar、California、美国、91342-1437
- Olive View - UCLA Medical Center
-
Vallejo、California、美国、94592
- Touro University California - Metabolic Research Center
-
-
Florida
-
Delray Beach、Florida、美国、33445
- Florida Kidney Physicians - Delray Beach Nephrology
-
Ocoee、Florida、美国、34761
- West Orange Endocrinology & Clinical Research
-
Port Charlotte、Florida、美国、33952
- Innovative Research Institute
-
West Palm Beach、Florida、美国、33401
- Metabolic Research Institute, Inc.
-
-
Georgia
-
Atlanta、Georgia、美国、30303
- Grady Memorial Hospital - Endocrinology
-
East Point、Georgia、美国、30344
- Southeast Kidney Associates - East Point
-
Savannah、Georgia、美国、31406
- Velocity Clinical Research - Savannah
-
-
Louisiana
-
Metairie、Louisiana、美国、70006
- NOLA Care Clinical Research
-
Metairie、Louisiana、美国、70006
- Omega Clinical Research - Metairie
-
-
Massachusetts
-
Plymouth、Massachusetts、美国、02360
- South Shore Nephrology
-
-
Michigan
-
Saint Joseph、Michigan、美国、49085
- Lake Michigan Nephrology
-
Troy、Michigan、美国、48085
- Oakland Medical Research
-
-
Missouri
-
Kansas City、Missouri、美国、64128
- Kansas City VA Medical Center - Endocrinology
-
Kansas City、Missouri、美国、64111
- Clinical Research Consultants, a JCCT Company
-
St Louis、Missouri、美国、63136
- St. Louis Heart and Vascular, PC - Christian Hospital Office
-
St Louis、Missouri、美国、63110
- Center for Advanced Medicine - Diabetes Center
-
-
Nebraska
-
Lincoln、Nebraska、美国、68510
- Somnos Clinical Research
-
-
Nevada
-
Las Vegas、Nevada、美国、89102
- Healor Primary Care / CCT Research
-
Las Vegas、Nevada、美国、89119
- CCT Research - Santa Rosa Medical Centers of Nevada
-
-
New York
-
Middletown、New York、美国、10941
- Circuit Clinical/Crystal Run
-
-
North Carolina
-
Asheboro、North Carolina、美国、27203
- Randolph Health Internal Medicine in Asheboro
-
Chapel Hill、North Carolina、美国、27514
- UNC Hospitals Outpatient Center at Eastowne - Nephrology
-
Greenville、North Carolina、美国、27834
- Eastern Nephrology Associates - Greenville West
-
Hendersonville、North Carolina、美国、28792
- Blue Sky, MD/ Lamond Family Medicine
-
Kinston、North Carolina、美国、28504
- Eastern Nephrology Associates - Kinston
-
-
Ohio
-
Cincinnati、Ohio、美国、45242
- Velocity Clinical Research - Blue Ash
-
-
South Dakota
-
Dakota Dunes、South Dakota、美国、57049
- Dunes Clinical Research LLC
-
-
Tennessee
-
Memphis、Tennessee、美国、38119
- DarSalud Care / LifeDOC Research
-
Memphis、Tennessee、美国、38163
- The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology
-
-
Texas
-
Corpus Christi、Texas、美国、78414
- Office of Osvaldo A. Brusco, MD
-
Dallas、Texas、美国、75208
- Thyroid, Endocrinology, and Diabetes - Dallas
-
El Paso、Texas、美国、79925
- DaVita Clinical Research- El Paso
-
Houston、Texas、美国、77008
- Global Kidney Center
-
Houston、Texas、美国、77024-2593
- Victorium Clinical Research
-
Lewisville、Texas、美国、75057
- North Texas Kidney Disease Associates Lewisville
-
McAllen、Texas、美国、78503
- Biopharma Informatic - McAllen, TX
-
San Antonio、Texas、美国、78212
- Clinical Advancement Center, PLLC
-
San Antonio、Texas、美国、78229
- UT Health San Antonio - Medical Arts & Research Center - Endocrinology
-
-
Utah
-
Salt Lake City、Utah、美国、84117
- Olympus Family Medicine
-
-
Virginia
-
Salem、Virginia、美国、24153
- Salem VA Medical Center - Endocrinology
-
-
Washington
-
Spokane、Washington、美国、99202
- MultiCare Rockwood Clinic Diabetes & Endocrinology Center
-
-
-
-
Gelderland
-
Apeldoorn、Gelderland、荷兰、7334 DZ
- Gelre Ziekenhuizen
-
-
North Holland
-
Amsterdam、North Holland、荷兰、1091 AC
- Onze Lieve Vrouwe Gasthuis
-
-
South Holland
-
Dordrecht、South Holland、荷兰、3318 AT
- Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
-
-
Utrecht
-
Amersfoort、Utrecht、荷兰、3818 TZ
- Meander Medisch Centrum
-
-
-
-
-
Many Locations、西班牙
- Many locations
-
-
A Coruña
-
A Coruña、A Coruña、西班牙、15006
- Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion
-
Ferrol、A Coruña、西班牙、15405
- Area Sanitaria De Ferrol | Medicina Interna
-
-
Barcelona
-
Barcelona、Barcelona、西班牙、08035
- Hospital Universitari Vall D Hebron | Nefrologia
-
Barcelona、Barcelona、西班牙、8023
- Hospital Quironsalud Barcelona | Internal Medicine Department
-
-
Granada
-
Granada、Granada、西班牙、18014
- Hospital Universitario Virgen De Las Nieves | Medicina Interna
-
-
Madrid
-
Alcalá de Henares、Madrid、西班牙、28805
- Hospital Universitario Principe De Asturias | Nefrologia
-
Madrid、Madrid、西班牙、28040
- Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department
-
Majadahonda、Madrid、西班牙、28222
- Hospital Universitario Puerta De Hierro De Majadahonda | Nefrologia
-
-
Málaga
-
Málaga、Málaga、西班牙、20910
- Hospital Universitario Virgen De La Victoria | Endocrinologia y Nutricion
-
-
Sevilla
-
Castilleja de la Cuesta、Sevilla、西班牙、41950
- Hospital Nisa Sevilla Aljarafe | Endocrinologia y Nutricion
-
-
Valencia
-
Valencia、Valencia、西班牙、46010
- Hospital Clinico Universitario De Valencia | Cardiologia
-
Valencia、Valencia、西班牙、46017
- Hospital Universitario Dr Peset Aleixandre | Nefrologia
-
-
-
-
-
Gyeonggi-do、韩国、425-707
- Ansan Hospital | Nephrology
-
Seoul、韩国、5278
- Kyung Hee University Hospital at Gangdong
-
Seoul、韩国、7442
- Hallym University Kangnam Sacred Heart Hospital
-
-
Chungcheongnam-do
-
Cheonan、Chungcheongnam-do、韩国、31151
- Soon Chun Hyang University Cheonan Hospital
-
-
Gang''Weondo
-
Wŏnju、Gang''Weondo、韩国、26426
- Yonsei University Wonju Christian Hospital
-
-
Gyeonggi-do
-
Guri-si、Gyeonggi-do、韩国、471-701
- Hanyang University Guri Hospital
-
-
Gyeonggido
-
Anyang-si、Gyeonggido、韩国、14068
- Hallym University Sacred Heart Hospital
-
Seongnam-si、Gyeonggido、韩国、13620
- Seoul National University Bundang Hospital
-
-
Incheon Gwang''Yeogsi
-
Incheon、Incheon Gwang''Yeogsi、韩国、21431
- The Catholic University of Korea, Incheon St.Mary's Hospital
-
-
Seoul Teugbyeolsi
-
Seoul、Seoul Teugbyeolsi、韩国、3080
- Seoul National University Hospital
-
Seoul、Seoul Teugbyeolsi、韩国、03722
- Severance Hospital, Yonsei University Health System
-
Seoul、Seoul Teugbyeolsi、韩国、05505
- Asan Medical Center | Ophthalmology
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
临床诊断为慢性肾脏病 (CKD) 和以下情况的参与者：
- A 部分：eGFR 40-90 ml/min/1.73m^2 （不超过 20% 的 eGFR >75 ml/min/1.73m^2） 在筛选访视时使用慢性肾脏病流行病学协作 (CKD EPI) 公式和至少一个 eGFR 历史值 <60 mL/min/1.73 3 个月内 m^2 或有 CKD 注册诊断。
- B 部分：eGFR 30-90 ml/min/1.73m^2 （不超过 20% 的 eGFR >75 ml/min/1.73m^2） 在筛选访视时使用 CKD-EPI 公式并且 eGFR 的至少一个历史值 <60 mL/min/1.73 m^2 在 3 个月内或有 CKD 的注册诊断。
- 筛选访视时 300 ≤UACR <5000 mg/g（3 个早晨排尿样本的平均值）并且在筛选前至少 3 个月在参与者的医疗记录中记录白蛋白尿/蛋白尿（定量或半定量测量）
- 患有美国糖尿病协会 (ADA 2021) 定义的 2 型糖尿病 (T2D) 且筛查时糖化血红蛋白 (HbA1c) <11% 的参与者。
- 根据研究者的判断，参与者接受了临床最大耐受剂量的血管紧张素转换酶抑制剂 (ACEi) 或血管紧张素受体阻滞剂 (ARB) 治疗超过 1 个月，但不能同时使用这两种药物。
排除标准：
- 患有 1 型糖尿病 (T1D) 的参与者。
- 肝功能不全的参与者被归类为 Child-Pugh C.
- 第 1 天就诊时血压高于 160/100 或收缩压低于 90 mmHg 的参与者。
- 目前正在接受钠/葡萄糖协同转运蛋白 2 抑制剂 (SGLT2i) 或 SGLT-1/2i 治疗的参与者，或者接受过 SGLT2i 或 SGLT-1/2i 且至少在筛选访视前 8 周和研究干预治疗期间不能停药的参与者.
- 接受另一种盐皮质激素受体拮抗剂 (MRA)（例如，依普利酮、艾赛利酮、螺内酯、坎利酮）、肾素抑制剂、钾补充剂、保钾利尿剂（例如，阿米洛利、氨苯蝶啶）、钾结合剂或血管紧张素受体治疗的参与者-脑啡肽酶抑制剂 (ARNI)，在筛选访视前至少 8 周和研究干预治疗期间不能停药。
- 目前正在接受治疗或在筛选访视前 8 周内接受 Finerenone (Kerendia©) 治疗的参与者。
- 筛选时血清/血浆钾 (K+) 高于 4.8 mmol/L 的参与者。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Finerenone 和恩格列净
参与者将服用 Finerenone（10 或 20 毫克，每日一次 [OD]）和 Empagliflozin（10 毫克 OD），持续长达 180 天。
|
口服给药，每日一次
口服给药，每日一次，如果筛查 eGFR（估计肾小球滤过率）结果为：
口服给药，如果筛查 eGFR（估计肾小球滤过率）结果为：≥60 mL/min/1.73，每日一次
平方米
|
|
实验性的：Finerenone 和 Empagliflozin 安慰剂
参与者将服用 Finerenone（10 或 20 mg OD）以及与 Empagliflozin (OD) 相匹配的安慰剂，疗程长达 180 天。
|
口服给药，每日一次，如果筛查 eGFR（估计肾小球滤过率）结果为：
口服给药，如果筛查 eGFR（估计肾小球滤过率）结果为：≥60 mL/min/1.73，每日一次
平方米
将安慰剂与恩格列净口服给药相匹配，每日一次
|
|
实验性的：恩格列净和 Finerenone 安慰剂
参与者将服用 Empagliflozin (10 mg OD) 和与 Finerenone (OD) 相匹配的安慰剂。
长达 180 天。
|
口服给药，每日一次
将安慰剂与 Finerenone 口服给药相匹配，每日一次
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Empagliflozin Alone
大体时间：Baseline and Day 180
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline, estimated using a mixed model for repeated measures.
The treatment effect is expressed as the ratio of LS means for the combination therapy group compared with empagliflozin alone.
A ratio below 1 indicates a reduction in UACR relative to baseline.
UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with chronic kidney disease and type 2 diabetes.
|
Baseline and Day 180
|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 180 Relative to Baseline in the Combination Therapy Group Versus Finerenone Alone
大体时间：Baseline and Day 180
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 180 relative to baseline in the combination therapy group compared with finerenone alone, estimated using a mixed model for repeated measures.
A ratio below 1 indicates a reduction in UACR relative to baseline.
UACR is a measurement of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
|
Baseline and Day 180
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at Day 210 Relative to Day 180
大体时间：Up to 210 days
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) at Day 210 (30 days after stopping the treatment) relative to Day 180, estimated using a mixed model for repeated measures.
A ratio above 1 indicates an increase in UACR at Day 210 compared with Day 180.
UACR is a measurement of albuminuria, a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
|
Up to 210 days
|
|
Least Squares Mean Ratio of Urinary Albumin-to-Creatinine Ratio (UACR) at 30 Days After End of Treatment Relative to Baseline
大体时间：Baseline to Day 210 (30 days after End of Treatment)
|
Least squares mean ratio of urinary albumin-to-creatinine ratio (UACR) relative to baseline, estimated using a mixed model for repeated measures.
A ratio below 1 indicates a reduction in UACR relative to baseline.
UACR is a marker of albuminuria and a predictor of long-term renal and cardiovascular outcomes in participants with type 2 diabetes.
|
Baseline to Day 210 (30 days after End of Treatment)
|
|
Number of Participants by Relative Change in UACR Category at Day 180 (>30%, >40%, >50%)
大体时间：At Day 180
|
This outcome summarizes the number of participants whose relative change from baseline in urine albumin-to-creatinine ratio (UACR) at Day 180 met prespecified category thresholds (>30%, >40%, or >50%).
Relative change was assessed based on baseline and post-baseline UACR measurements.
Percentages were calculated using as denominator the number of participants with both a baseline and at least one post-baseline UACR assessment within the specified timeframe.
Participants were classified independently within each category.
|
At Day 180
|
|
Change From Baseline in eGFR at 30 Days
大体时间：At Day 30
|
Change from baseline to Day 30 in estimated glomerular filtration rate (eGFR) was evaluated for each treatment group.
Change was calculated as the value at Day 30 minus the baseline value.
Negative values indicate a decrease from baseline and positive values indicate an increase from baseline.
|
At Day 30
|
|
Number of Participants With an eGFR Decline Greater Than 30% at 30 Days From Baseline
大体时间：Up to 30 days
|
Up to 30 days
|
|
|
Change in eGFR at 180 Days and 210 Days From Day 30
大体时间：At Day 180 and Day 210
|
Change in estimated glomerular filtration rate (eGFR) from Day 30 to Day 180 and Day 210 was evaluated for each treatment group.
Change was calculated as the value at Day 180 or Day 210 minus the value at Day 30.
Positive values indicate an increase from Day 30 and negative values indicate a decrease from Day 30.
|
At Day 180 and Day 210
|
|
Number of Participants With AKI Events
大体时间：Up to 180 days
|
AKI is defined as any of the following:
|
Up to 180 days
|
|
Total Number of AKI Events
大体时间：Up to 180 days
|
AKI is defined as any of the following:
|
Up to 180 days
|
|
Number of Participants With Hyperkalemia Events (Moderate Hyperkalemia [5.5 <K+ ≤6.0 mmol/L], Severe Hyperkalemia [K+ >6.0 mmol/L])
大体时间：Up to 180 days
|
Moderate hyperkalemia was defined as K+ >5.5 to ≤6.0 mmol/L and severe hyperkalemia was defined as K+ >6.0 mmol/L).
|
Up to 180 days
|
|
Change From Baseline in K+
大体时间：At baseline, day 14 and day 180
|
Serum potassium values (mmol/L) were assessed at baseline and scheduled post-baseline visits.
Results are presented as observed mean potassium concentrations at each time point.
|
At baseline, day 14 and day 180
|
|
Number of Participants With Symptomatic Hypotension Events
大体时间：Up to 180 days
|
Number of participants who experienced at least one symptomatic hypotension event during the study period
|
Up to 180 days
|
|
Total Number of Symptomatic Hypotension Events
大体时间：Up to 180 days
|
Symptomatic hypotension events were assessed at all study visits and were documented as adverse events.
The outcome represents the total number of symptomatic hypotension events reported during the study period.
|
Up to 180 days
|
|
Number of Participants With Genital Mycotic Events
大体时间：Up to 180 days
|
The outcome represents the number of participants who experienced at least one genital mycotic event during the study period.
|
Up to 180 days
|
|
Total Number of Genital Mycotic Events
大体时间：Up to 180 days
|
Occurrence of urinary tract infection events were assessed at all study visits and documented as AEs.
|
Up to 180 days
|
|
Number of Participants With Urosepsis and Pyelonephritis Events
大体时间：Up to 180 days
|
Up to 180 days
|
|
|
Total Number of Urosepsis and Pyelonephritis Events
大体时间：Up to 180 days
|
Occurrence of urosepsis and pyelonephritis events were assessed at all study visits and documented as AEs.
|
Up to 180 days
|
|
Number of Participants With Ketoacidosis Events
大体时间：Up to 180 days
|
Up to 180 days
|
|
|
Total Number of Ketoacidosis Events
大体时间：Up to 180 days
|
Occurrence of ketoacidosis events were assessed at all study visits and documented as AEs.
|
Up to 180 days
|
|
Number of Participants With Necrotizing Fasciitis of the Perineum Events
大体时间：Up to 180 days
|
Up to 180 days
|
|
|
Number of Participants With Severe Hypoglycemia Events
大体时间：Up to 180 days
|
Severe hypoglycemia was defined as glucose level of <3.0 mmol/L (<54 mg/dL) is sufficiently low to indicate serious, clinically important hypoglycemia.
In addition, severe hypoglycemia, as defined by the ADA denotes severe cognitive impairment requiring external assistance for recovery.
|
Up to 180 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Zachariah T, Radhakrishnan J. Potential Role of Mineralocorticoid Receptor Antagonists in Nondiabetic Chronic Kidney Disease and Glomerular Disease. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1499-1512. doi: 10.2215/CJN.0000000000000540. Epub 2024 Jul 22.
- Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.
- Agarwal R, Correa-Rotter R, Navaneethan SD, Heerspink HJL, Weir MR, McGill JB, Mottl AK, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Scott C, Li L, Brinker M, Kovesdy CP, Green JB, Mann JFE. Safety and Synergy of Finerenone and Empagliflozin in Lowering Blood Pressure. Hypertension. 2026 Jun 5. doi: 10.1161/HYPERTENSIONAHA.126.27036. Online ahead of print.
- Agarwal R, Correa-Rotter R, Navaneethan SD, Fukami K, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Scott C, Li L, Aldworth C, Green JB, Weir MR. Acute eGFR Changes and Their Mediation of Albuminuria Reduction with Empagliflozin and Finerenone. J Am Soc Nephrol. 2026 Mar 29. doi: 10.1681/ASN.0000001071. Online ahead of print.
- Agarwal R, Green JB, Heerspink HJL, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Vaduganathan M, Solis-Herrera C, Scott C, Li L, Brinker M, Aldworth C, Mann JFE. Risk of Hyperkalemia With Empagliflozin, Finerenone, or Both: Secondary Analysis of the CONFIDENCE Randomized Trial. J Am Coll Cardiol. 2026 Feb 24;87(7):772-784. doi: 10.1016/j.jacc.2025.10.049. Epub 2025 Nov 7.
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl A, Osonoi T, Pal A, Rossing P, Rosenstock J, Vaduganathan M, Li L, Li N, Scott C, Manjrekar P, Yamashita S, Nangaku M. Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Urinary Albumin-to-Creatinine Ratio in Asia: Pre-Specified Analysis of CONFIDENCE. Clin J Am Soc Nephrol. 2026 Jan 1;21(1):72-82. doi: 10.2215/CJN.0000000865. Epub 2025 Sep 18.
- Vaduganathan M, Green JB, Heerspink HJL, Kim SG, Mann JFE, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Rohwedder K, Scott C, Agarwal R. Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial. Nephrol Dial Transplant. 2025 Dec 23;41(1):161-170. doi: 10.1093/ndt/gfaf160.
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.
- Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE investigators. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics. Nephrol Dial Transplant. 2025 Aug 1;40(8):1559-1569. doi: 10.1093/ndt/gfaf022.
- Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年6月23日
初级完成 (实际的)
2025年3月14日
研究完成 (实际的)
2025年3月17日
研究注册日期
首次提交
2022年2月4日
首先提交符合 QC 标准的
2022年2月23日
首次发布 (实际的)
2022年2月24日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 21839
- 2021-003037-11 (EudraCT编号)
- 2023-506981-30-00 (注册表标识符：CTIS)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
该研究数据的可用性稍后将根据拜耳对 EFPIA/PhRMA“负责任的临床试验数据共享原则”的承诺来确定。 这涉及数据访问的范围、时间点和过程。 因此，拜耳承诺根据合格研究人员的要求，共享患者层面的临床试验数据、研究层面的临床试验数据，以及美国和欧盟批准的药物和适应症的患者临床试验方案，以进行合法研究。 这适用于欧盟和美国监管机构在 2014 年 1 月 1 日或之后批准的新药和适应症的数据。
感兴趣的研究人员可以使用 www.vivli.org 请求访问匿名的患者级别数据和临床研究的支持文件以进行研究。 门户网站的会员部分提供了有关拜耳上市研究标准的信息和其他相关信息。
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.