Trial Condition(s):
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 (CONFIDENCE)
Bayer Identifier:
21839
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-506981-30-00
臨床試験の目的
フィネレノンは、ミネラルコルチコイド受容体というタンパク質を阻害して作用します。ミネラルコルチコイド受容体による刺激が増加すると腎臓の傷害や炎症が引き起こされることが知られており、CKDにも関与すると考えられています。
エンパグリフロジンは、血液中のブドウ糖の尿中排泄を促し、血糖値を低下させます。
本試験では、フィネレノンおよびエンパグリフロジンについて、それぞれの単独治療よりも併用療法の方が被験者の腎機能悪化を遅らせる効果があることを調べることを目的としています。このため、尿中のタンパク値を測定します。また、単独療法と比べ併用療法の安全性についても調べたいとしています。
治療群により、被験者はフィネレノンおよびエンパグリフロジンを併用、フィネレノンをプラセボと併用、またはエンパグリフロジンをプラセボと併用し、1日1回経口で服用します。プラセボの見かけは治験薬と同じですが、有効成分は何も含まれていません。重要なことは、被験者はCKDおよびT2Dに対して現在服用している薬剤も継続して服用することです。
被検者は最長7.5 ヵ月治験に参加し、6 ヵ月間治療を受けます。治験期間中、被験者には治験実施施設に7回、来院していただきます。
治験チームは次のことを行います。
• 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
有害事象とは、治験中に起こる問題のことです。医師は、それらの事象が治験の治療とは関連がないと思われる場合でも、試験期間中に発生するあらゆる事象を記録します。
組み入れ基準
- 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.
除外基準
- 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).
臨床試験の概要
Enrollment Goal
Trial Dates
Phase
プラセボを服用する可能性はありますか
Products
Accepts Healthy Volunteers
参加場所
| 場所 | |
|---|---|
場所 多くの場所 Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 多くの場所 Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Meridian Clinical Research- Savannah Savannah, United States, 31406 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 多くの場所 Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 多くの場所 Many Locations, France | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 多くの場所 Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Diabetologische Schwerpunkt Praxis Dortmund Dortmund, Germany, 44137 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Zentrum für Diabetologie und Ernährungsmedizin Ludwigshafen, Germany, 67059 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 St. Josefskrankenhaus Heidelberg, Germany, 69115 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Diabetes Zentrum Wandsbek Hamburg, Germany, 22041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Cardiologicum Pirna / Dresden-Seidnitz Pirna, Germany, 1796 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 ClinPhenomics GmbH&Co. KG Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hopital Carémeau - Nîmes Nîmes, France, 30029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Center Hospitalier Michallon - Grenoble GRENOBLE CEDEX 9, France, 38043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hôpital François Mitterrand - Dijon Dijon, France, 21000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hopital Carémeau - Nîmes Nîmes, France, 30029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hôpital Saint Joseph PARIS, France, 75014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Saiseikai Matsuyama Hospital Matsuyama, Japan, 791-8026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Medical Corporation Taifukukai, Osaka Nishiumeda Clinic Osaka, Japan, 530-0001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Fukuoka University Chikushi Hospital Chikushino, Japan, 818-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Japanese Red Cross Kumamoto Hospital Kumamoto, Japan, 861-8520 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Naka Kinen Clinic Naka-shi, Japan, 311-0113 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Kokura Memorial Hospital Kitakyushu, Japan, 802-8555 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hirohata Naika Clinic Kitakyushu, Japan, 807-0857 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Fukui-ken Saiseikai Hospital Fukui, Japan, 918-8503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital Fukuoka, Japan, 811-0213 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 ATS Sardegna - ASSL Olbia Sassari, Italy, 7026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo Verona, Italy, 37134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 ASL 4 Chiavarese Genova, Italy, 16043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia Orbassano, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 ASST Rhodense Rho, Italy, 20017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Azienda Ospedaliero Universitaria Parma - SC Nefrologia Parma, Italy, 43126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Quironsalud Barcelona | Internal Medicine Department Barcelona, Spain, 8023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition A Coruna, Spain, 15006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Principe de Asturias Alcalá de Henares, Spain, 28805 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial Ferrol, Spain, 15405 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Regionaal ZH Jan Yperman Campus Mariaziekenhuis IEPER, Belgium, 8900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 AZ Groeninge Campus Kennedylaan Kortrijk, Belgium, 8500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 AZ Delta ROESELARE, Belgium, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 CHU de Charleroi Hôpital civil Lodelinsart, Belgium, 6042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 AZ St-Lucas Campus St-Lucas gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department DORDRECHT, Netherlands, 3318 AT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Gelre Ziekenhuizen APELDOORN, Netherlands, 7334 DZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Meander Medisch Centrum AMERSFOORT, Netherlands, 3818 TZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Onze Lieve Vrouwe Gasthuis AMSTERDAM, Netherlands, 1091 AC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department Herning, Denmark, DK-7400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Bispebjerg Hospital - Hjerteafdeling København, Denmark, DK-2400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital of South West Jutland | Department of Endocrinology Research Esbjerg, Denmark, 6700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Health Corporation of the Ziv Medical Center (R.A.) Zefat, Israel, 1311001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Barzilai Medical Center | Department of Nephrology and Hypertension Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 HaEmek Medical Center | Internal Medicine C Department - Research Unit Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department Petach Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Edith Wolfson Medical Center | Internal Medicine Department Holon, Israel, 5822012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Far Eastern Memorial Hospital | Nephrology Department New Taipei City, Taiwan, China, 220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Changhua Christian Hospital Changhua, Taiwan, China, 50006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Taipei Medical University - Shuang Ho Hospital New Taipei City, Taiwan, China, 23561 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 China Medical University Hospital Taichung, Taiwan, China, 404327 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Friedrich-Schiller-Uni. Jena Jena, Germany, 7747 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Clinical Research Consultants Kansas City, United States, 64111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Office of Osvaldo A. Brusco, MD Corpus Christi, United States, 78414-4173 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Academic Medical Research Institute Los Angeles, United States, 90022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Kansas City VA Medical Center Kansas City, United States, 64128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Meridian Clinical Research- Norfolk Norfolk, United States, 68701 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 DaVita Clinical Research- El Paso El Paso, United States, 79925 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Circuit Clinical/Crystal Run Middletown, United States, 10941 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Salem VA Medical Center - Endocrinology Salem, United States, 24153 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 University of Tennessee Health Science Center Memphis, United States, 38163 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Randolph Medical Associates Asheboro, United States, 27203 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Clinical Advancement Center, PLLC San Antonio, United States, 78212-4740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Velocity Clinical Research, Cincinnati Cincinnati, United States, 45242 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 St. Louis Heart & Vascular, PC Saint Louis, United States, 63136 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Eastern Nephrology Associates / Greenville NC Greenville, United States, 27834 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Washington University School of Medicine in St. Louis Saint Louis, United States, 63110-1010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Chase Medical Research, LLC Waterbury, United States, 06708 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Somnos Clinical Research Lincoln, United States, 68510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Omega Clinical Research Center Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Emory University School of Medicine Atlanta, United States, 30329 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Olympus Family Medicine Salt Lake City, United States, 84117 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Eastern Nephrology Associates - Kinston Kinston, United States, 28504 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Healor Primary Care / CCT Research Las Vegas, United States, 89102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Versailles Family Medicine Versailles, United States, 40383 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 University of North Carolina Kidney Center Chapel Hill, United States, 27599-7155 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Casa Sollievo della Sofferenza - Endocrinologia San Giovanni Rotondo, Italy, 71013 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hamilton Medical Research Group Hamilton, Canada, L8M 1K7 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Sameh Fikry Professional Corporation Waterloo, Canada, N2J 1C4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Recherche GCP Research Montreal, Canada, H2R 1V6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 LMC Manna Research - Calgary Calgary, Canada, T2H 2G4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Centre Hospitalier de l’Université de Montréal (CHUM) Montreal, Canada, H2X 3E4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Bluewater Clinical Research Group Sarnia, Canada, N7T 4X3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 LMC Clinical Research Inc. Montreal Ville Saint-Laurent, Canada, H4T 1Z9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Severance Hospital, Yonsei University Health System Seoul, Unmapped, 03722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Asan Medical Center Seoul, Unmapped, 138-736 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Yonsei University Wonju Christian Hospital Wonju, Unmapped, 26426 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hallym University Sacred Heart Hospital Anyang-si, Unmapped, 14068 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Chung Nam National University Hospital Daejeon, Unmapped, 35015 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Seoul National University Hospital Seoul, Unmapped, 3080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 MultiCare Rockwood Clinic Diabetes & Endocrinology Center Spokane, United States, 99202 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Santa Rosa Medical Centers of Nevada / CCT Research Las Vegas, United States, 89119 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Biopharma Informatic, LLC McAllen, United States, 78503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Universitario Dr. Peset Valencia, Spain, 46017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Clinical Research Solutions, Inc. Kitchener, Canada, N2H 5Z8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Blue Sky, MD/ Lamond Family Medicine Hendersonville, United States, 28792 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department Majadahonda, Spain, 28222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Vithas Sevilla | Endocrinology Department Castilleja de la Cuesta, Spain, 41950 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 H. Costa del Sol (Marbella) Marbella, Spain, 29603 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hospital Clinico San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Eternal Heart Care Centre (EHCC) and Research Institute Jaipur, India, 302020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Government Medical College Kozhikode, India, 673008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Vinaya Hospital and Research Centre (A Unit of KIMS) Mangalore, India, 575003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Sawami Man Singh (SMS) Medical College & Attached Hospitals Jaipur, India, 302017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Krishna Institute Of Medical Science Secunderabad, India, 500003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Manipal Hospital Bangalore, India, 560017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belgaum, India, 590010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Institute of Post-Graduate Medical Education and Research Kolkata, India, 700020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Lifepoint Multispecialty Hospital Pune, India, 411057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital Mumbai, India, 400 012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 G.S.V.M. Medical College Kanpur, India, 208002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Dr. Bantwal's Clinic Bengaluru, India, 560076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Bangalore Medical College & Research Institute Bengaluru, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Mavani Dialysis & Kidney Center Ahmedabad, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Sriram Chandra Bhanj Medical College & Hospital Cuttack, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Vedanta Kidney Care Vadodara, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Government Kilpauk Medical College Hospital Chennai, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Indraprastha Apollo Hospital New Delhi, India, TBC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Osmania General Hospital Telangana, India, 500012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Government Medical College and Hospital (GMCH) Nagpur Nagpur, India, 440009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Grant Medical Foundation - Ruby Hall Clinic (RHC) Pune, India, 411001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 King George Hospital Visakhapatnam, India, NA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Asian Kidney Hospital and Medical Centre Nagapur, India, 440010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Nizam's Institute of Medical Sciences (NIMS) Hyderabad, India, 500082 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Dunes Clinical Research LLC Dakota Dunes, United States, 57049 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 DarSalud Care / LifeDOC Research Memphis, United States, 38119 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 West Orange Endocrinology & Clinical Research Ocoee, United States, 34761-4547 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Innovative Research Institute Port Charlotte, United States, 33952 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Victorium Clinical Research Houston, United States, 77024-2593 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 South Shore Nephrology Plymouth, United States, 02360 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Global Kidney Center Houston, United States, 77008 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Oakland Medical Center Dakota Dunes, United States, 48085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Nola Care Clinical Research Los Angeles, United States, 70006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Thyroid, Endocrinology, and Diabetes (TED) PA Dallas, United States, 75208-2362 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Lake Michigan Nephrology Saint Joseph, United States, 49085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 North Texas Kidney Disease Associates, PLLC Lewisville, United States, 75057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Florida Kidney Physicians Delray Beach, United States, 33445 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Southeast Kidney Associates East Point, United States, 30344 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Touro University California Vallejo, United States, 94592 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Northridge Hospital Northridge, United States, 91325 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Olive View - UCLA Medical Center Sylmar, United States, 91342-1437 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Southwest Kidney Institute, PLC Surprise, United States, 85374 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Metabolic Research Institute, Inc. West Palm Beach, United States, 33401-3430 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 University of Texas Health Science Center San Antonio, United States, 78249 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Jiyugaoka Yamada Internal Medicine Clinic Obihiro, Japan, 080-0848 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia Chieti, Italy, 66100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 William Osler Health centre, Sakuara Medical Mississauga, Canada, L5H4K9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst Aalst, Belgium, 9300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Clalit Health | Soroka Medical Center - Internal Medicine Department Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Kyung Hee University Hospital at Gangdong Seoul, Unmapped, 5278 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Seoul National University Bundang Hospital Seongnam-si, Unmapped, 13620 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hanyang University Guri Hospital Gyeonggi-do, Unmapped, 11923 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hallym University Kangnam Sacred Heart Hospital Seoul, Unmapped, 7442 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Korea University Ansan Hospital Gyeonggi-do, Unmapped, 425-707 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 The Catholic University of Korea, Incheon St.Mary's Hospital Incheon, Unmapped, 21431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office Hakusan, Japan, 924-8588 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Soon Chun Hyang University Cheonan Hospital Cheonan, Unmapped, 31151 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Hadassah University Medical Center (HUMC) Jerusalem, Israel, 911200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 Max Super Speciality Hospital (MSSH) - Saket New Delhi, India, 110017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
場所 All India Institute of Medical Sciences Bhubaneswar, India, 751019 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
試験デザイン
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:
該当なし
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin aloneUrinary albumin to-creatinine ratio (UACR)Timeframe: Up to 180 days
- Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone aloneTimeframe: Up to 180 days
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin aloneTimeframe: Upto 180 days
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone aloneTimeframe: 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)Timeframe: Up to 210 days
- Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)Timeframe: Up to 210 days
- Relative change in UACR category (>30%, >40%, >50%) at 180 daysTimeframe: Up to 180 days
- Ratio of change from baseline in eGFR at 30 daysestimated glomerular filtration rate (eGRF)Timeframe: Up to 30 days
- eGFR decline greater than 30% at 30 days from baselineTimeframe: Up to 30 days
- Ratio of change in eGFR at 180 days and 210 days from Day 30Timeframe: Up to 210 days
- Proportion of participants with of acute kidney injury (AKI) eventsAKI 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 hoursTimeframe: Up to 180 days
- Total number of AKI eventsTimeframe: 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+)Timeframe: 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])Timeframe: Up to 180 days
- Change from baseline in K+Timeframe: Up to 180 days
- Proportion of participants with severe hypoglycemia eventsSevere hypoglycemia is defined as glucose level of <3.0 mmol/L (<54 mg/dL).Timeframe: Up to 180 days
- Total number of events of severe hypoglycemia eventsTimeframe: Up to 180 days
- Proportion of participants with symptomatic hypotension eventsTimeframe: Up to 180 days
- Total number of symptomatic hypotension eventsTimeframe: Up to 180 days
- Proportion of participants with genital mycotic eventsTimeframe: Up to 180 days
- Total number of genital mycotic eventsTimeframe: Up to 180 days
- Proportion of participants with ketoacidosis eventsTimeframe: Up to 180 days
- Total number of ketoacidosis eventsTimeframe: Up to 180 days
- Proportion of participants with necrotizing fasciitis of the perineum eventsTimeframe: Up to 180 days
- Total number of necrotizing fasciitis of the perineum eventsTimeframe: Up to 180 days
- Proportion of participants with urosepsis and pyelonephritis eventsTimeframe: Up to 180 days
- Total number of urosepsis and pyelonephritis eventsTimeframe: Up to 180 days
追加情報
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