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NCT05254002CompletedPhase 2

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

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.

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
1664 (actual)
First submitted
4 Feb 2022
Start date
23 Jun 2022
Primary completion date
14 Mar 2025
Lead sponsor
Bayer
NCT number
NCT05254002
EU CT number
2023-506981-30-00
EudraCT number
2021-003037-11

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 1664
  • From 23 Jun 2022 to the primary completion date, 14 Mar 2025
  • 176 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.

Other illness

  • Participants with type 1 diabetes (T1D).
  • Participant with hepatic insufficiency classified as Child-Pugh C.

Lab values

  • 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.
  • Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value).

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (176)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumCompleted
HUmani
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CharleroiBelgiumCompleted
AZ Sint-Lucas & Volkskliniek
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GentBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
Jan Yperman Ziekenhuis
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IeperBelgiumCompleted
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Algemeen Ziekenhuis Delta
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RoeselareBelgiumCompleted
Hamilton Medical Research Group
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HamiltonCanadaUnknown status
William Osler Health centre, Sakuara Medical
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MississaugaCanadaUnknown status
GCP Research | Montreal
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MontrealCanadaUnknown status
Centre Hospitalier de l'Universite de Montreal (CHUM) | Cardiology
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MontrealCanadaUnknown status
LMC Clinical Research Inc. Montreal
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Saint-LaurentCanadaUnknown status
Bluewater Clinical Research Group
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SarniaCanadaUnknown status
Sameh Fikry Professional Corporation
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WaterlooCanadaUnknown status
Clinical Research Solutions Inc.
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WaterlooCanadaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
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DortmundGermanyCompleted
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
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DresdenGermanyCompleted
ClinPhenomics CVC GmbH
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Frankfurt am MainGermanyCompleted
Diabetes Zentrum Wandsbek Diabetologische Schwerpunktpraxis Berufsausuebungsgemeinschaft GbR
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HamburgGermanyCompleted
St. Josefskrankenhaus Heidelberg GmbH
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HeidelbergGermanyCompleted
Universitaetsklinikum Jena KöR
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JenaGermanyCompleted
Die Praxis am Ludwigsplatz
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LudwigshafenGermanyCompleted
Region Hovedstaden
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Copenhagen NvDenmarkCompleted
Esbjerg Og Grindsted Sygehus
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EsbjergDenmarkCompleted
Steno Diabetes Center Copenhagen
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HerlevDenmarkCompleted
Region Midtjylland
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HerningDenmarkCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Universitario Principe de Asturias
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Alcalá de HenaresSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Quirónsalud Barcelona
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BarcelonaSpainCompleted
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainCompleted
Area Sanitaria De Ferrol
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FerrolSpainCompleted
Hospital Universitario Virgen de las Nieves
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GranadaSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
Hospital Costa del Sol
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MarbellaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Hospital Universitario Dr. Peset Aleixandre
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ValenciaSpainCompleted
Centre Hospitalier Universitaire de Dijon
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DijonFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Hospital Edouard Herriot
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LyonFranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceCompleted
CHRU De Nancy
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Vandoeuvre Les NancyFranceCompleted
HaEmek Medical Center | Internal Medicine C Department - Research Unit
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AfulaIsraelUnknown status
Barzilai Medical Center | Department of Nephrology and Hypertension
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AshkelonIsraelUnknown status
Clalit Health | Soroka Medical Center - Internal Medicine Department
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BeershebaIsraelUnknown status
Edith Wolfson Medical Center | Internal Medicine Department
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HolonIsraelUnknown status
Hadassah University Medical Center (HUMC)
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JerusalemIsraelUnknown status
Health Corporation of Galilee Medical Center
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NahariyaIsraelUnknown status
Health Corporation of the Ziv Medical Center (R.A.)
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SafedIsraelUnknown status
Mavani Dialysis & Kidney Center
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AhmedabadIndiaUnknown status
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
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BelagaviIndiaUnknown status
Dr. Bantwal's Clinic
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BengaluruIndiaUnknown status
Bangalore Medical College & Research Institute
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BengaluruIndiaUnknown status
All India Institute of Medical Sciences
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BhubaneswarIndiaUnknown status
Government Kilpauk Medical College Hospital
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ChennaiIndiaUnknown status
Sriram Chandra Bhanj Medical College & Hospital
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CuttackIndiaUnknown status
Nizam's Institute of Medical Sciences (NIMS)
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HyderabadIndiaUnknown status
Sawami Man Singh (SMS) Medical College & Attached Hospitals
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JaipurIndiaUnknown status
Eternal Heart Care Centre (EHCC) and Research Institute
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JaipurIndiaUnknown status
G.S.V.M. Medical College
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KanpurIndiaUnknown status
Institute of Post-Graduate Medical Education and Research
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KolkataIndiaUnknown status
Government Medical College
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KozhikodeIndiaUnknown status
Vinaya Hospital and Research Centre (A Unit of KIMS)
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MangaloreIndiaUnknown status
Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
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MumbaiIndiaUnknown status
Manipal Hospital
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MysoreIndiaUnknown status
Asian Kidney Hospital and Medical Centre
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NagpurIndiaUnknown status
Government Medical College and Hospital (GMCH) Nagpur
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NagpurIndiaUnknown status
Indraprastha Apollo Hospital
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New DelhiIndiaUnknown status
Max Super Speciality Hospital (MSSH) - Saket
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New DelhiIndiaUnknown status
Grant Medical Foundation - Ruby Hall Clinic (RHC)
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PuneIndiaUnknown status
Lifepoint Multispecialty Hospital
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PuneIndiaUnknown status
Krishna Institute Of Medical Science
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SecunderabadIndiaUnknown status
Osmania General Hospital
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TelanganaIndiaUnknown status
Vedanta Kidney Care
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VadodaraIndiaUnknown status
King George Hospital
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VisakhapatnamIndiaUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyCompleted
Azienda Sociosanitaria Ligure N 4 Sistema Sanitario Regione Liguria
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ChiavariItalyCompleted
Universita' Degli Studi G. D'Annunzio Di Chieti
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Chieti ScaloItalyCompleted
Azienda Socio Sanitaria Territoriale Rhodense
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Garbagnate MilaneseItalyCompleted
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
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MilanItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Azienda Socio Sanitaria Locale N 2 Della Gallura
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OlbiaItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Azienda Ospedaliero Universitaria Parma
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ParmaItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyCompleted
Fukuoka University Chikushi Hospital
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Chikushino-shiJapanUnknown status
Fukui-ken Saiseikai Hospital
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Fukui-shiJapanUnknown status
Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
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FukuokaJapanUnknown status
Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
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HakusanJapanUnknown status
Hirohata Naika Clinic
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KitakyushuJapanUnknown status
Kokura Memorial Hospital
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KitakyushuJapanUnknown status
Many Locations
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Many LocationsJapanUnknown status
Saiseikai Matsuyama Hospital
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MatsuyamaJapanUnknown status
Naka Kinen Clinic
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NakaJapanUnknown status
Jiyugaoka Yamada Internal Medicine Clinic
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ObihiroJapanUnknown status
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
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OsakaJapanUnknown status
Osaka General Medical Center
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OsakaJapanUnknown status
Hallym University Sacred Heart Hospital
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Anyang-siSouth KoreaUnknown status
Soon Chun Hyang University Cheonan Hospital
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CheonanSouth KoreaUnknown status
Hanyang University Guri Hospital
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Guri-siSouth KoreaUnknown status
Ansan Hospital | Nephrology
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Gyeonggi-doSouth KoreaUnknown status
The Catholic University of Korea, Incheon St. Mary's Hospital
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IncheonSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaUnknown status
Asan Medical Center | Ophthalmology
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SeoulSouth KoreaUnknown status
Hallym University Kangnam Sacred Heart Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Yonsei University Wonju Christian Hospital
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WŏnjuSouth KoreaUnknown status
Meander Medisch Centrum
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AmersfoortNetherlandsCompleted
Stichting OLVG
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AmsterdamNetherlandsCompleted
Gelre Hospitals
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ApeldoornNetherlandsCompleted
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsCompleted
Changhua Christian Hospital
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ChanghuaTaiwanUnknown status
Chang Gung Memorial Hospital, Kaohsiung
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Kaohsiung CityTaiwanUnknown status
Many Locations
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Many LocationsTaiwanUnknown status
Far Eastern Memorial Hospital | Nephrology Department
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New Taipei CityTaiwanUnknown status
Taipei Medical University Shuang Ho Hospital
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New Taipei CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Randolph Health Internal Medicine in Asheboro
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AsheboroUnited StatesUnknown status
Grady Memorial Hospital - Endocrinology
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AtlantaUnited StatesUnknown status
UNC Hospitals Outpatient Center at Eastowne - Nephrology
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Chapel HillUnited StatesUnknown status
Velocity Clinical Research - Blue Ash
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CincinnatiUnited StatesUnknown status
Office of Osvaldo A. Brusco, MD
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Corpus ChristiUnited StatesUnknown status
Dunes Clinical Research LLC
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Dakota DunesUnited StatesUnknown status
Thyroid, Endocrinology, and Diabetes - Dallas
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DallasUnited StatesUnknown status
Florida Kidney Physicians - Delray Beach Nephrology
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Delray BeachUnited StatesUnknown status
Southeast Kidney Associates - East Point
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East PointUnited StatesUnknown status
DaVita Clinical Research- El Paso
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El PasoUnited StatesUnknown status
Eastern Nephrology Associates - Greenville West
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GreenvilleUnited StatesUnknown status
Blue Sky, MD/ Lamond Family Medicine
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HendersonvilleUnited StatesUnknown status
Global Kidney Center
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HoustonUnited StatesUnknown status
Victorium Clinical Research
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HoustonUnited StatesUnknown status
Kansas City VA Medical Center - Endocrinology
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Kansas CityUnited StatesUnknown status
Clinical Research Consultants, a JCCT Company
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Kansas CityUnited StatesUnknown status
Eastern Nephrology Associates - Kinston
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KinstonUnited StatesUnknown status
Healor Primary Care / CCT Research
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Las VegasUnited StatesUnknown status
CCT Research - Santa Rosa Medical Centers of Nevada
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Las VegasUnited StatesUnknown status
North Texas Kidney Disease Associates Lewisville
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LewisvilleUnited StatesUnknown status
Somnos Clinical Research
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LincolnUnited StatesUnknown status
Academic Medical Research Institute
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Los AngelesUnited StatesUnknown status
Biopharma Informatic - McAllen, TX
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McAllenUnited StatesUnknown status
DarSalud Care / LifeDOC Research
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MemphisUnited StatesUnknown status
The University of Tennessee Health Science Center - Medical Center Clinic - Nephrology
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MemphisUnited StatesUnknown status
Omega Clinical Research - Metairie
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MetairieUnited StatesUnknown status
NOLA Care Clinical Research
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MetairieUnited StatesUnknown status
Circuit Clinical/Crystal Run
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MiddletownUnited StatesUnknown status
Dignity Health Northridge Hospital Medical Center - Nephrology
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NorthridgeUnited StatesUnknown status
West Orange Endocrinology & Clinical Research
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OcoeeUnited StatesUnknown status
South Shore Nephrology
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PlymouthUnited StatesUnknown status
Innovative Research Institute
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Port CharlotteUnited StatesUnknown status
Lake Michigan Nephrology
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Saint JosephUnited StatesUnknown status
Salem VA Medical Center - Endocrinology
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SalemUnited StatesUnknown status
Olympus Family Medicine
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Salt Lake CityUnited StatesUnknown status
UT Health San Antonio - Medical Arts & Research Center - Endocrinology
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San AntonioUnited StatesUnknown status
Clinical Advancement Center, PLLC
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San AntonioUnited StatesUnknown status
Velocity Clinical Research - Savannah
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SavannahUnited StatesUnknown status
MultiCare Rockwood Clinic Diabetes & Endocrinology Center
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SpokaneUnited StatesUnknown status
Center for Advanced Medicine - Diabetes Center
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St LouisUnited StatesUnknown status
St. Louis Heart and Vascular, PC - Christian Hospital Office
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St LouisUnited StatesUnknown status
Southwest Kidney Institute, PLC - Suprise
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SurpriseUnited StatesUnknown status
Olive View-UCLA Medical Center
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SylmarUnited StatesUnknown status
Oakland Medical Research
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TroyUnited StatesUnknown status
Touro University California - Metabolic Research Center
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VallejoUnited StatesUnknown status
Metabolic Research Institute, Inc
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West Palm BeachUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.