check_circleStudy Completed
Type 2 diabetes mellitus, Chronic kidney disease
Bayer Identifier:
21839
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
2023-506981-30-00
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.
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
AllAge
18 - N/ATrial summary
Enrollment Goal
1664Trial Dates
June 2022 - March 2025Phase
Phase 2Could I Receive a placebo
YesProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Recruiting | Many Locations | Many Locations, Italy |
Recruiting | Many Locations | Many Locations, Taiwan |
Completed | Velocity Clinical Research - Savannah | Savannah, 31406, United States |
Recruiting | Many Locations | Many Locations, Japan |
Recruiting | Many Locations | Many Locations, France |
Recruiting | Many Locations | Many Locations, Spain |
Completed | Diabetologische Schwerpunkt Praxis Dortmund | Dortmund, 44137, Germany |
Completed | Zentrum für Diabetologie und Ernährungsmedizin | Ludwigshafen, 67059, Germany |
Withdrawn | St. Josefskrankenhaus | Heidelberg, 69115, Germany |
Completed | Diabetes Zentrum Wandsbek | Hamburg, 22041, Germany |
Completed | Cardiologicum Pirna / Dresden-Seidnitz | Pirna, 1796, Germany |
Active, not recruiting | Charité Campus Benjamin Franklin (CBF) | Berlin, 12203, Germany |
Active, not recruiting | ClinPhenomics GmbH&Co. KG | Frankfurt, 60596, Germany |
Completed | Hopital Carémeau - Nîmes | Nîmes, 30029, France |
Completed | Center Hospitalier Michallon - Grenoble | La Tronche (Grenoble area), 38043, France |
Active, not recruiting | CHU Dijon - Hopital Francois Miterrand | Dijon, 21000, France |
Completed | Hopital Carémeau - Nîmes | Nîmes, 30029, France |
Completed | Hôpital Edouard Herriot - Lyon Cedex | Lyon, 69003, France |
Completed | Hôpital Saint Joseph | Paris, 75014, France |
Completed | Saiseikai Matsuyama Hospital | Matsuyama, 791-8026, Japan |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Medical Corporation Taifukukai, Osaka Nishiumeda Clinic | Osaka, 530-0001, Japan |
Completed | Fukuoka University Chikushi Hospital | Chikushino, 818-8502, Japan |
Withdrawn | Japanese Red Cross Kumamoto Hospital | Kumamoto, 861-8520, Japan |
Completed | Naka Kinen Clinic | Naka-shi, 311-0113, Japan |
Completed | Kokura Memorial Hospital | Kitakyushu, 802-8555, Japan |
Completed | Hirohata Naika Clinic | Kitakyushu, 807-0857, Japan |
Completed | Fukui-ken Saiseikai Hospital | Fukui, 918-8503, Japan |
Completed | Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital | Fukuoka, 811-0213, Japan |
Completed | Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico | Milano, 20132, Italy |
Completed | Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia | Olbia, 07026, Italy |
Completed | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia | Bergamo, 24127, Italy |
Completed | Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica | Milano, 20142, Italy |
Withdrawn | Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo | Verona, 37134, Italy |
Withdrawn | ASP di Catania | Catania, 95124, Italy |
Completed | ASL N 4 SSR Liguria_Ospedale di Chiavari - Diabetologia e Malattie Metaboliche | Chiavari, 16043, Italy |
Completed | Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia | Orbassano, 10043, Italy |
Completed | Azienda Socio Sanitaria Territoriale Rhodense | Rho, 20017, Italy |
Completed | Azienda Ospedaliero Universitaria Parma - SC Nefrologia | Parma, 43126, Italy |
Withdrawn | Hospital De Jerez De La Frontera | Cardiologia | Jerez de la Frontera, 11407, Spain |
Completed | Hospital Quironsalud Barcelona | Internal Medicine Department | Barcelona, 8023, Spain |
Withdrawn | Hospital Universitario 12 De Octubre | Nefrologia | Madrid, 28041, Spain |
Completed | Complexo Hospitalario Universitario A Coruna | Endocrinologia y Nutricion | A Coruña, 15006, Spain |
Completed | Hospital Universitario Virgen De Las Nieves | Medicina Interna | Granada, 18014, Spain |
Completed | Hospital Universitario Principe De Asturias | Nefrologia | Alcalá de Henares, 28805, Spain |
Withdrawn | Complexo Hospitalario Universitario De Santiago | Nefrologia | Santiago de Compostela, 15706, Spain |
Completed | Hospital Clinico Universitario De Valencia | Cardiologia | Valencia, 46010, Spain |
Completed | Area Sanitaria De Ferrol | Medicina Interna | Ferrol, 15405, Spain |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Jan Yperman Ziekenhuis | IEPER, 8900, Belgium |
Completed | AZ Groeninge Campus Kennedylaan | Kortrijk, 8500, Belgium |
Completed | AZ Delta | ROESELARE, 8800, Belgium |
Not yet recruiting | CHU de Charleroi Hôpital civil | Lodelinsart, 6042, Belgium |
Withdrawn | UZ Antwerpen | EDEGEM, 2650, Belgium |
Withdrawn | AZ St-Lucas Campus St-Lucas | gent, 9000, Belgium |
Completed | Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department | Dordrecht, 3318 AT, Netherlands |
Withdrawn | Academisch Medisch Centrum (AMC) | AMSTERDAM, 1105 AZ, Netherlands |
Completed | Gelre Ziekenhuizen | Apeldoorn, 7334 DZ, Netherlands |
Completed | Meander Medisch Centrum | Amersfoort, 3818 TZ, Netherlands |
Completed | Onze Lieve Vrouwe Gasthuis | Amsterdam, 1091 AC, Netherlands |
Completed | Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department | Herning, 7400, Denmark |
Completed | Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department | Herlev, 2730, Denmark |
Completed | Bispebjerg Hospital - Hjerteafdeling | Kobenhavn, 2400, Denmark |
Completed | Hospital of South West Jutland | Department of Endocrinology Research | Esbjerg, 6700, Denmark |
Withdrawn | DMC - Diabetes Medical Center | Tel Aviv, 6937947, Israel |
Completed | Health Corporation of the Ziv Medical Center (R.A.) | Zefat, 1311001, Israel |
Completed | Barzilai Medical Center | Department of Nephrology and Hypertension | Ashkelon, 7830604, Israel |
Completed | Health Corporation of Galilee Medical Center | Nahariya, 2210001, Israel |
Completed | HaEmek Medical Center | Internal Medicine C Department - Research Unit | Afula, 1834111, Israel |
Withdrawn | Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department | Petach Tikva, 4941492, Israel |
Completed | Edith Wolfson Medical Center | Internal Medicine Department | Holon, 5822012, Israel |
Completed | Far Eastern Memorial Hospital | Nephrology Department | New Taipei City, 220, Taiwan |
Completed | Changhua Christian Hospital | Changhua City, 50006, Taiwan |
Completed | Chang Gung Memorial Hospital Kaohsiung | Kaohsiung, 833, Taiwan |
Completed | Taipei Medical University - Shuang Ho Hospital | New Taipei City, 23561, Taiwan |
Completed | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Completed | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Completed | China Medical University Hospital | Taichung, 404327, Taiwan |
Withdrawn | National Taiwan University Hospital | Taipei, 100, Taiwan |
Completed | Friedrich-Schiller-Uni. Jena | Jena, 7747, Germany |
Completed | Clinical Research Consultants, a JCCT Company | Kansas City, 64111, United States |
Withdrawn | University of Texas Health Science Center | San Antonio, 78229-3900, United States |
Completed | Office of Osvaldo A. Brusco, MD | Corpus Christi, 78414, United States |
Completed | Academic Medical Research Institute | Los Angeles, 90022, United States |
Withdrawn | Cook County Health and Hospital System | Chicago, 60612, United States |
Completed | Kansas City VA Medical Center - Endocrinology | Kansas City, 64128, United States |
Withdrawn | Velocity Clinical Research Norfolk | Norfolk, 68701, United States |
Completed | DaVita Clinical Research- El Paso | El Paso, 79925, United States |
Active, not recruiting | Circuit Clinical/Crystal Run | Middletown, 10941, United States |
Completed | Salem VA Medical Center - Endocrinology | Salem, 24153, United States |
Completed | The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology | Memphis, 38163, United States |
Completed | Randolph Health Internal Medicine in Asheboro | Asheboro, 27203, United States |
Completed | Clinical Advancement Center, PLLC | San Antonio, 78212, United States |
Active, not recruiting | Velocity Clinical Research - Blue Ash | Cincinnati, 45242, United States |
Completed | St. Louis Heart and Vascular, PC - Christian Hospital Office | Saint Louis, 63136, United States |
Completed | Eastern Nephrology Associates - Greenville West | Greenville, 27834, United States |
Completed | Center for Advanced Medicine - Diabetes Center | Saint Louis, 63110, United States |
Withdrawn | Chase Medical Research, LLC | Waterbury, 06708, United States |
Active, not recruiting | Somnos Clinical Research | Lincoln, 68510, United States |
Completed | Omega Clinical Research - Metairie | Metairie, 70006, United States |
Completed | Grady Memorial Hospital - Endocrinology | Atlanta, 30303, United States |
Completed | Olympus Family Medicine | Salt Lake City, 84117, United States |
Completed | Eastern Nephrology Associates - Kinston | Kinston, 28504, United States |
Withdrawn | Desert Clinical Research - CCT Research | Mesa, 85213, United States |
Completed | Healor Primary Care / CCT Research | Las Vegas, 89102, United States |
Withdrawn | Versailles Family Medicine | Versailles, 40383, United States |
Completed | UNC Hospitals Outpatient Center at Eastowne - Nephrology | Chapel Hill, 27514, United States |
Completed | Casa Sollievo della Sofferenza - Endocrinologia | San Giovanni Rotondo, 71013, Italy |
Completed | Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia | Pisa, 56124, Italy |
Active, not recruiting | Hamilton Medical Research Group | Hamilton, L8M 1K7, Canada |
Completed | Sameh Fikry Professional Corporation | Waterloo, N2J 1C4, Canada |
Withdrawn | Centricity Research Mirabel Multispecialty | Mirabel, J7J 2K8, Canada |
Completed | GCP Research | Montreal | Montreal, H1M 1B1, Canada |
Withdrawn | LMC Manna Research - Bayview | Toronto, M4G 3E8, Canada |
Withdrawn | LMC Manna Research - Brampton | Brampton, L6S 0C6, Canada |
Withdrawn | LMC Manna Research - Thornhill | Concord, L4K 4M2, Canada |
Withdrawn | LMC Manna Research - Etobicoke | Etobicoke, M9R 4E1, Canada |
Withdrawn | LMC Manna Research - Barrie | TBC, L4N 7L3, Canada |
Withdrawn | LMC Manna Research - Calgary | Calgary, T2H 2G4, Canada |
Active, not recruiting | Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology | Montréal, H2X 0A9, Canada |
Active, not recruiting | Bluewater Clinical Research Group | Sarnia, N7T 4X3, Canada |
Completed | LMC Clinical Research Inc. Montreal | Ville Saint-Laurent, H4T 1Z9, Canada |
Withdrawn | LMC Manna Research - Ottawa | Nepean, K2J 0V2, Canada |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Completed | Asan Medical Center | Ophthalmology | Seoul, 05505, Korea,_republic_of |
Completed | Yonsei University Wonju Christian Hospital | Wonju-si, 26426, Korea,_republic_of |
Completed | Hallym University Sacred Heart Hospital | Anyang-si, 14068, Korea,_republic_of |
Withdrawn | Chung Nam National University Hospital | Daejeon, 35015, Korea,_republic_of |
Completed | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Completed | MultiCare Rockwood Clinic Diabetes & Endocrinology Center | Spokane, 99202, United States |
Completed | CCT Research - Santa Rosa Medical Centers of Nevada | Las Vegas, 89119, United States |
Withdrawn | Cleveland Clinic Foundation | Cleveland, 44195, United States |
Completed | Biopharma Informatic - McAllen, TX | McAllen, 78503, United States |
Completed | Hospital Universitario Dr Peset Aleixandre | Nefrologia | Valencia, 46017, Spain |
Completed | Hospital Universitari Vall D Hebron | Nefrologia | Barcelona, 08035, Spain |
Completed | Clinical Research Solutions, Inc. | Waterloo, N2T 0C1, Canada |
Active, not recruiting | Blue Sky, MD/ Lamond Family Medicine | Hendersonville, 28792, United States |
Completed | Hospital Universitario Puerta De Hierro De Majadahonda | Nefrologia | Majadahonda, 28222, Spain |
Completed | Hospital Nisa Sevilla Aljarafe | Endocrinologia y Nutricion | Castilleja de la Cuesta, 41950, Spain |
Completed | Hospital Universitario Virgen De La Victoria | Endocrinologia y Nutricion | Málaga, 20910, Spain |
Completed | Hospital Universitario Fundacion Jimenez Diaz | Nephrology and Hypertension Department | Madrid, 28040, Spain |
Withdrawn | Hospital Costa Del Sol | Medicina Interna | Marbella, 29603, Spain |
Withdrawn | Hospital Clinico San Carlos | Medicina Interna | Madrid, 28040, Spain |
Completed | Eternal Heart Care Centre (EHCC) and Research Institute | Jaipur, 302020, India |
Completed | Government Medical College | Kozhikode, 673008, India |
Completed | Vinaya Hospital and Research Centre (A Unit of KIMS) | Mangalore, 575003, India |
Completed | Sawami Man Singh (SMS) Medical College & Attached Hospitals | Jaipur, 302017, India |
Completed | Krishna Institute Of Medical Science | Secunderabad, 500003, India |
Completed | Manipal Hospital | Mysore, 570015, India |
Completed | K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre | Belgaum, 590010, India |
Completed | Institute of Post-Graduate Medical Education and Research | Kolkata, 700020, India |
Not yet recruiting | Lifepoint Multispecialty Hospital | Pune, 411057, India |
Completed | Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital | Mumbai, 400012, India |
Completed | G.S.V.M. Medical College | Kanpur, 208002, India |
Not yet recruiting | Dr. Bantwal's Clinic | Bengaluru, 560076, India |
Not yet recruiting | Bangalore Medical College & Research Institute | Bengaluru, NA, India |
Completed | Mavani Dialysis & Kidney Center | Ahmedabad, 380052, India |
Not yet recruiting | Sriram Chandra Bhanj Medical College & Hospital | Cuttack, NA, India |
Completed | Vedanta Kidney Care | Vadodara, 390007, India |
Completed | Government Kilpauk Medical College Hospital | Chennai, 600010, India |
Completed | Indraprastha Apollo Hospital | New Delhi, 110076, India |
Completed | Osmania General Hospital | Telangana, 500012, India |
Not yet recruiting | Government Medical College and Hospital (GMCH) Nagpur | Nagpur, 440009, India |
Completed | Grant Medical Foundation - Ruby Hall Clinic (RHC) | Pune, 411001, India |
Completed | King George Hospital | Visakhapatnam, 530002, India |
Completed | Asian Kidney Hospital and Medical Centre | Nagpur, 440010, India |
Completed | Nizam's Institute of Medical Sciences (NIMS) | Hyderabad, 500082, India |
Completed | Dunes Clinical Research LLC | Dakota Dunes, 57049, United States |
Completed | DarSalud Care / LifeDOC Research | Memphis, 38119, United States |
Withdrawn | Dr Nowreen Haq Endocrinology Clinic | Annapolis, 21401, United States |
Completed | West Orange Endocrinology & Clinical Research | Ocoee, 34761, United States |
Completed | Innovative Research Institute | Port Charlotte, 33952, United States |
Not yet recruiting | Victorium Clinical Research | Houston, 77024-2593, United States |
Withdrawn | East Coast Institute for Research, Inc. - Jacksonville | Jacksonville, 32204, United States |
Active, not recruiting | South Shore Nephrology | Plymouth, 02360, United States |
Completed | Global Kidney Center | Houston, 77008, United States |
Completed | Oakland Medical Research | Troy, 48085, United States |
Completed | Nola Care Clinical Research | Metairie, 70006, United States |
Completed | Thyroid, Endocrinology, and Diabetes - Dallas | Dallas, 75208, United States |
Completed | Lake Michigan Nephrology | Saint Joseph, 49085, United States |
Completed | North Texas Kidney Disease Associates Lewisville | Lewisville, 75057, United States |
Completed | Florida Kidney Physicians - Delray Beach Nephrology | Delray Beach, 33445, United States |
Completed | Southeast Kidney Associates - East Point | East Point, 30344, United States |
Completed | Touro University California - Metabolic Research Center | Vallejo, 94592, United States |
Completed | Dignity Health Northridge Hospital Medical Center - Nephrology | Northridge, 91325, United States |
Not yet recruiting | Olive View - UCLA Medical Center | Sylmar, 91342-1437, United States |
Withdrawn | Baliga Family Practice | Columbus, 31904, United States |
Completed | Southwest Kidney Institute, PLC - Suprise | Surprise, 85374, United States |
Withdrawn | Advent Health | Orlando, 32804, United States |
Completed | Metabolic Research Institute, Inc. | West Palm Beach, 33401, United States |
Completed | UT Health San Antonio - Medical Arts & Research Center - Endocrinology | San Antonio, 78229, United States |
Completed | Jiyugaoka Yamada Internal Medicine Clinic | Obihiro, 080-0848, Japan |
Completed | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia | Milano, 20122, Italy |
Completed | Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia | Chieti, 66100, Italy |
Completed | William Osler Health centre, Sakuara Medical | Mississauga, L5H4K9, Canada |
Active, not recruiting | Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst | Aalst, 9300, Belgium |
Completed | Clalit Health | Soroka Medical Center - Internal Medicine Department | Beer Sheva, 8410101, Israel |
Completed | Kyung Hee University Hospital at Gangdong | Seoul, 5278, Korea,_republic_of |
Completed | Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea,_republic_of |
Completed | Hanyang University Guri Hospital | Guri-si, 471-701, Korea,_republic_of |
Completed | Hallym University Kangnam Sacred Heart Hospital | Seoul, 7442, Korea,_republic_of |
Completed | Ansan Hospital | Nephrology | Gyeonggi-do, 425-707, Korea,_republic_of |
Completed | The Catholic University of Korea, Incheon St.Mary's Hospital | Incheon, 21431, Korea,_republic_of |
Completed | Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office | Hakusan, 924-8588, Japan |
Completed | Soon Chun Hyang University Cheonan Hospital | Cheonan, 31151, Korea,_republic_of |
Completed | Hadassah University Medical Center (HUMC) | Jerusalem, 911200, Israel |
Not yet recruiting | Max Super Speciality Hospital (MSSH) - Saket | New Delhi, 110017, India |
Not yet recruiting | All India Institute of Medical Sciences | Bhubaneswar, 751019, India |
Withdrawn | Nephrology Associates Of Northern Illinois And Ind - Fort Wayne | Fort Wayne, 46804, United States |
Withdrawn | Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale | Hinsdale, 60521, United States |
Primary Outcome
- Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin aloneUrinary 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 alonedate_rangeTime Frame:Up to 180 days
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alonedate_rangeTime Frame:Upto 180 days
- Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alonedate_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 daysdate_rangeTime Frame:Up to 180 days
- Ratio of change from baseline in eGFR at 30 daysestimated glomerular filtration rate (eGRF)date_rangeTime Frame:Up to 30 days
- eGFR decline greater than 30% at 30 days from baselinedate_rangeTime Frame:Up to 30 days
- Ratio of change in eGFR at 180 days and 210 days from Day 30date_rangeTime Frame: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 hoursdate_rangeTime Frame:Up to 180 days
- Total number of AKI eventsdate_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 eventsSevere 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 eventsdate_rangeTime Frame:Up to 180 days
- Proportion of participants with symptomatic hypotension eventsdate_rangeTime Frame:Up to 180 days
- Total number of symptomatic hypotension eventsdate_rangeTime Frame:Up to 180 days
- Proportion of participants with genital mycotic eventsdate_rangeTime Frame:Up to 180 days
- Total number of genital mycotic eventsdate_rangeTime Frame:Up to 180 days
- Proportion of participants with ketoacidosis eventsdate_rangeTime Frame:Up to 180 days
- Total number of ketoacidosis eventsdate_rangeTime Frame:Up to 180 days
- Proportion of participants with necrotizing fasciitis of the perineum eventsdate_rangeTime Frame:Up to 180 days
- Total number of necrotizing fasciitis of the perineum eventsdate_rangeTime Frame:Up to 180 days
- Proportion of participants with urosepsis and pyelonephritis eventsdate_rangeTime Frame:Up to 180 days
- Total number of urosepsis and pyelonephritis eventsdate_rangeTime Frame:Up to 180 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3