Clinical trial NCT05254002: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 1664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone
timeFrame: Up to 180 days
measure: Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone
timeFrame: Up to 180 days
measure: Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone
timeFrame: Upto 180 days
measure: Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone
timeFrame: Up to 180 days
Secondary outcomes:
measure: 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
measure: Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)
timeFrame: Up to 210 days
measure: Relative change in UACR category (>30%, >40%, >50%) at 180 days
timeFrame: Up to 180 days
measure: Ratio of change from baseline in eGFR at 30 days
timeFrame: Up to 30 days
measure: eGFR decline greater than 30% at 30 days from baseline
timeFrame: Up to 30 days
measure: Ratio of change in eGFR at 180 days and 210 days from Day 30
timeFrame: Up to 210 days
measure: Proportion of participants with of acute kidney injury (AKI) events
timeFrame: Up to 180 days
measure: Total number of AKI events
timeFrame: Up to 180 days
measure: Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])
timeFrame: Up to 180 days
measure: 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
measure: Change from baseline in K+
timeFrame: Up to 180 days
measure: Proportion of participants with severe hypoglycemia events
timeFrame: Up to 180 days
measure: Total number of events of severe hypoglycemia events
timeFrame: Up to 180 days
measure: Proportion of participants with symptomatic hypotension events
timeFrame: Up to 180 days
measure: Total number of symptomatic hypotension events
timeFrame: Up to 180 days
measure: Proportion of participants with genital mycotic events
timeFrame: Up to 180 days
measure: Total number of genital mycotic events
timeFrame: Up to 180 days
measure: Proportion of participants with ketoacidosis events
timeFrame: Up to 180 days
measure: Total number of ketoacidosis events
timeFrame: Up to 180 days
measure: Proportion of participants with necrotizing fasciitis of the perineum events
timeFrame: Up to 180 days
measure: Total number of necrotizing fasciitis of the perineum events
timeFrame: Up to 180 days
measure: Proportion of participants with urosepsis and pyelonephritis events
timeFrame: Up to 180 days
measure: Total number of urosepsis and pyelonephritis events
timeFrame: Up to 180 days
Other outcomes:
Locations:
city: Surprise
country: United States
facility: Southwest Kidney Institute, PLC
state: Arizona
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Northridge
country: United States
facility: Northridge Hospital
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Vallejo
country: United States
facility: Touro University California
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Delray Beach
country: United States
facility: Florida Kidney Physicians - Delray Beach Nephrology
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology & Clinical Research
state: Florida
city: Port Charlotte
country: United States
facility: Innovative Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital - Endocrinology
state: Georgia
city: East Point
country: United States
facility: Southeast Kidney Associates
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research - Savannah
state: Georgia
city: Versailles
country: United States
facility: Versailles Family Medicine
state: Kentucky
city: Metairie
country: United States
facility: Nola Care Clinical Research
state: Louisiana
city: Metairie
country: United States
facility: Omega Clinical Research Center
state: Louisiana
city: Plymouth
country: United States
facility: South Shore Nephrology
state: Massachusetts
city: Saint Joseph
country: United States
facility: Lake Michigan Nephrology
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center - Endocrinology
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart & Vascular, PC
state: Missouri
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research- Norfolk
state: Nebraska
city: Las Vegas
country: United States
facility: Healor Primary Care / CCT Research
state: Nevada
city: Las Vegas
country: United States
facility: Santa Rosa Medical Centers of Nevada / CCT Research
state: Nevada
city: Middletown
country: United States
facility: Circuit Clinical/Crystal Run
state: New York
city: Asheboro
country: United States
facility: Randolph Medical Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Kidney Center
state: North Carolina
city: Greenville
country: United States
facility: Eastern Nephrology Associates - Greenville West
state: North Carolina
city: Hendersonville
country: United States
facility: Blue Sky, MD/ Lamond Family Medicine
state: North Carolina
city: Kinston
country: United States
facility: Eastern Nephrology Associates - Kinston
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati
state: Ohio
city: Dakota Dunes
country: United States
facility: Oakland Medical Center
state: South Dakota
city: Dakota Dunes
country: United States
facility: Dunes Clinical Research LLC
state: South Dakota
city: Memphis
country: United States
facility: DarSalud Care / LifeDOC Research
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Office of Osvaldo A. Brusco, MD
state: Texas
city: Dallas
country: United States
facility: Thyroid, Endocrinology, and Diabetes (TED) PA
state: Texas
city: El Paso
country: United States
facility: DaVita Clinical Research- El Paso
state: Texas
city: Houston
country: United States
facility: Global Kidney Center
state: Texas
city: Houston
country: United States
facility: Victorium Clinical Research
state: Texas
city: Lewisville
country: United States
facility: North Texas Kidney Disease Associates, PLLC
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic - McAllen, TX
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: Olympus Family Medicine
state: Utah
city: Salem
country: United States
facility: Salem VA Medical Center - Endocrinology
state: Virginia
city: Spokane
country: United States
facility: MultiCare Rockwood Clinic Diabetes & Endocrinology Center
state: Washington
city: Lodelinsart
country: Belgium
facility: CHU de Charleroi Hôpital civil
state: Hainaut
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis (OLVZ) - Campus Aalst
state: Oost-vlaanderen
city: Gent
country: Belgium
facility: AZ St-Lucas Campus St-Lucas
city: Gent
country: Belgium
facility: UZ Gent
city: Ieper
country: Belgium
facility: Regionaal ZH Jan Yperman Campus Mariaziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge Campus Kennedylaan
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Roeselare
country: Belgium
facility: AZ Delta
city: Calgary
country: Canada
facility: LMC Manna Research - Calgary
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Mississauga
country: Canada
facility: William Osler Health centre, Sakuara Medical
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group
state: Ontario
city: Waterloo
country: Canada
facility: Sameh Fikry Professional Corporation
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Solutions, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Ville Saint-Laurent
country: Canada
facility: LMC Clinical Research Inc. Montreal
state: Quebec
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland | Department of Endocrinology Research
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen | Herlev - Clinical and Translational Research Department
city: Herning
country: Denmark
facility: Region Midtjylland | Regionshospitalet Godstrup - Nephrology Department
city: København
country: Denmark
facility: Bispebjerg Hospital - Hjerteafdeling
city: Dijon
country: France
facility: Hôpital François Mitterrand - Dijon
city: Grenoble Cedex 9
country: France
facility: Center Hospitalier Michallon - Grenoble
city: Lyon Cedex
country: France
facility: Hôpital Edouard Herriot - Lyon Cedex
city: Multiple Locations
country: France
facility: Many Locations
city: Nîmes
country: France
facility: Hopital Carémeau - Nîmes
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Heidelberg
country: Germany
facility: St. Josefskrankenhaus
state: Baden-Württemberg
city: Frankfurt
country: Germany
facility: ClinPhenomics GmbH&Co. KG
state: Hessen
city: Dortmund
country: Germany
facility: Diabetologische Schwerpunkt Praxis Dortmund
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
facility: Zentrum für Diabetologie und Ernährungsmedizin
state: Rheinland-Pfalz
city: Pirna
country: Germany
facility: Cardiologicum Pirna / Dresden-Seidnitz
state: Sachsen
city: Jena
country: Germany
facility: Friedrich-Schiller-Uni. Jena
state: Thüringen
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin (CBF)
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wandsbek
city: Visakhapatnam
country: India
facility: King George Hospital
state: AP
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Mavani Dialysis & Kidney Center
state: GJ
city: Belgaum
country: India
facility: K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre
state: Karnataka
city: Mysore
country: India
facility: Manipal Hospital
state: Karnataka
city: Nagapur
country: India
facility: Asian Kidney Hospital and Medical Centre
state: MH
city: Jaipur
country: India
facility: Eternal Heart Care Centre (EHCC) and Research Institute
state: Rajasthan
city: Kanpur
country: India
facility: G.S.V.M. Medical College
state: Uttar Pradesh
city: Kolkata
country: India
facility: Institute of Post-Graduate Medical Education and Research
state: West Bengal
city: Bengaluru
country: India
facility: Dr. Bantwal's Clinic
city: Bengaluru
country: India
facility: Bangalore Medical College & Research Institute
city: Chennai
country: India
facility: Government Kilpauk Medical College Hospital
city: Cuttack
country: India
facility: Sriram Chandra Bhanj Medical College & Hospital
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences (NIMS)
city: Jaipur
country: India
facility: Sawami Man Singh (SMS) Medical College & Attached Hospitals
city: Kozhikode
country: India
facility: Government Medical College
city: Mangalore
country: India
facility: Vinaya Hospital and Research Centre (A Unit of KIMS)
city: Mumbai
country: India
facility: Seth Gordhandas Sunderdas Medical College (GSMC) - King Edward Memorial (KEM) Hospital
city: Nagpur
country: India
facility: Government Medical College and Hospital (GMCH) Nagpur
city: New Delhi
country: India
facility: Max Super Speciality Hospital (MSSH) - Saket
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic (RHC)
city: Pune
country: India
facility: Lifepoint Multispecialty Hospital
city: Secunderabad
country: India
facility: Krishna Institute Of Medical Science
city: Telangana
country: India
facility: Osmania General Hospital
city: Vadodara
country: India
facility: Vedanta Kidney Care
city: Afula
country: Israel
facility: HaEmek Medical Center | Internal Medicine C Department - Research Unit
city: Ashkelon
country: Israel
facility: Barzilai Medical Center | Department of Nephrology and Hypertension
city: Beer Sheva
country: Israel
facility: Clalit Health | Soroka Medical Center - Internal Medicine Department
city: Holon
country: Israel
facility: Edith Wolfson Medical Center | Internal Medicine Department
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center (HUMC)
city: Nahariya
country: Israel
facility: Health Corporation of Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center | Beilinson Hospital - Internal Medicine C Department
city: Zefat
country: Israel
facility: Health Corporation of the Ziv Medical Center (R.A.)
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria Parma - SC Nefrologia
state: Emilia-Romagna
city: Chiavari
country: Italy
facility: ASL 4 Chiavarese
state: Liguria
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Malattie Endocrine e Diabetologia
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Endocrinologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele s.r.l. - Medicina Generale Indirizzo Diabetologico ed Endocrino-Metabolico
state: Lombardia
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo_Ospedale S. Paolo - Gestione integrata della malattia Diabetica
state: Lombardia
city: Rho
country: Italy
facility: Azienda Socio Sanitaria Territoriale Rhodense
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Malattie Metaboliche Diabetologia
state: Piemonte
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza - Endocrinologia
state: Puglia
city: Olbia
country: Italy
facility: Azienda Socio Sanitaria Locale N 2 Della Gallura - Diabetologia
state: Sardegna
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana_Cisanello - Malattie Metaboliche e Diabetologia
state: Toscana
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona_Borgo Roma - Endocrinologia, Diabetologia e Malattie del Metabolismo
state: Veneto
city: Chieti
country: Italy
facility: Università degli Studi "G. D'Annunzio" di Chieti - Endocrinologia
city: Multiple Locations
country: Italy
facility: Many Locations
city: Matsuyama
country: Japan
facility: Saiseikai Matsuyama Hospital
state: Ehime
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Hirohata Naika Clinic
state: Fukuoka
city: Obihiro
country: Japan
facility: Jiyugaoka Yamada Internal Medicine Clinic
state: Hokkaido
city: Naka-shi
country: Japan
facility: Naka Kinen Clinic
state: Ibaraki
city: Hakusan
country: Japan
facility: Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
state: Ishikawa
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital
city: Fukuoka
country: Japan
facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
city: Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Multiple Locations
country: Japan
facility: Many Locations
city: Osaka
country: Japan
facility: Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
state: Chungcheongnamdo
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Christian Hospital
state: Gang''weondo
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St.Mary's Hospital
state: Incheon Gwang''yeogsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Daejeon
country: Korea, Republic of
facility: Chung Nam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis | Dordwijk - Cardiology Department
city: A Coruna
country: Spain
facility: Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition
state: A Coruña
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
state: A Coruña
city: Alcalá de Henares
country: Spain
facility: Hospital Principe de Asturias
state: Madrid
city: Marbella
country: Spain
facility: H. Costa del Sol (Marbella)
state: Malaga
city: Castilleja de la Cuesta
country: Spain
facility: Hospital Vithas Sevilla | Endocrinology Department
state: Sevilla
city: Barcelona
country: Spain
facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona | Internal Medicine Department
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves | Servicio de Endocrinologia y Nutricion
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Universidad Autonoma de Madrid (UAM) - Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda | Clinical Pharmacology Department
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria | Unidad de Investigacion Clinica - Endocrinology Department
city: Multiple Locations
country: Spain
facility: Many Locations
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung
city: Multiple Locations
country: Taiwan
facility: Many Locations
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital | Nephrology Department
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: