A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) | NCT06935357 | Trialant

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) | NCT06935357 | Trialant

Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)
Brief Summary: In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.

The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:

• How much does the amount of protein in the urine change from the start of the study to Week 36?

Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.

The study will be done as follows:

Participants will be screened to check if they can join the study.

Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.

Neither the researchers nor the participants will know what the participants will receive.

Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.

Afterwards, participants will enter a follow-up period which will last 80 weeks.

In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
Detailed Description: The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Key Inclusion Criteria:

Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.

An eGFR ≥ 30 mL/min/1.73 m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73 m^2 is acceptable for the cohorts 3 and 4.

Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.

Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.

Key Exclusion Criteria:

Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.

History of rapidly progressive variant of IgAN, defined as eGFR loss by > 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.

IgAN-(MCD) variant.

Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.

Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) > 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).

Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.

Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (> 7.5 milligrams per day [mg/d] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids > 7.5 mg/day prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.

Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.

Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.

Hypogammaglobulinemia: serum Immunoglobin G (IgG) < 6.0 gram per litre (g/L), at Screening.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Applied Research Center of ArkansasRecruiting

Little Rock, Arkansas 72205, United States

-Contact

501-804-5939

John HeifnerPrincipal Investigator

Kidney & Hypertension Center - Apple ValleyRecruiting

Apple Valley, California 92307, United States

Scripps Green HospitalRecruiting

Carlsbad, California 92009, United States

National Institute of clinical Research Administration OfficeWithdrawn

Garden Grove, California 92844-2751, United States

UCLA Health David Geffen School of MedicineRecruiting

Los Angeles, California 90095, United States

FOMAT Medical Research - FOMAT - PPDSRecruiting

Oxnard, California 93030, United States

North America Research Institute-San DimasRecruiting

San Dimas, California 91773, United States

Nova Clinical Research, LLCRecruiting

Bradenton, Florida 34209, United States

University of Florida - Gainesville - 1600 SW Archer RdRecruiting

Gainesville, Florida 32610, United States

Royal Research, Corp.Recruiting

Hollywood, Florida 33024, United States

Central Florida Kidney SpecialistsRecruiting

Orlando, Florida 32806, United States

CDC Research Institute, LLCRecruiting

Port Saint Lucie, Florida 34952, United States

American Clinical Trials LLCWithdrawn

Acworth, Georgia 30101, United States

The Vasculitis and Glomerulonephritis Center at Massachusetts General HospitalRecruiting

Boston, Massachusetts 02114-4724, United States

Brigham and Women's HospitalRecruiting

Boston, Massachusetts 02115-6110, United States

UMass Memorial Medical CenterNot yet recruiting

Worcester, Massachusetts 01655, United States

Henry Ford HospitalRecruiting

Detroit, Michigan 48202, United States

Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDSWithdrawn

Pontiac, Michigan 48341, United States

Anointed Nephrology and HTN - SKYCRNG - PPDSRecruiting

Brookhaven, Mississippi 39601, United States

Midwest Nephrology Associates,Inc.Withdrawn

City of Saint Peters, Missouri 63376, United States

Icahn School of Medicine at Mount SinaiNot yet recruiting

New York, New York 10029-6504, United States

James J Peters Veterans Administration Medical Center - NAVREF - PPDSRecruiting

The Bronx, New York 10468, United States

Penn Renal Electrolyte and Hypertension PerelmanNot yet recruiting

Philadelphia, Pennsylvania 19104, United States

Lifespan at Rhode Island HospitalRecruiting

Providence, Rhode Island 02903, United States

Knoxville Kidney Center, PLLCRecruiting

Knoxville, Tennessee 37923-3624, United States

Texas Kidney Institute - DallasRecruiting

Dallas, Texas 95231, United States

Provecta Research NetworkRecruiting

Houston, Texas 77054, United States

R & H Clinical ResearchRecruiting

Katy, Texas 77974, United States

Hospital Italiano de Buenos AiresRecruiting

Almagro, Ciudad Autónoma de BuenosAires C1199ABB, Argentina

INECO Neurociencias OroñoRecruiting

Rosario, Santa Fe Province 2000, Argentina

CIMER-Centro Integral de Medicina RespiratoriaRecruiting

San Miguel de Tucumán, Tucumán Province T4000CBC, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDSRecruiting

Buenos Aires, B1605, Argentina

DOM Centro de ReumatologíaRecruiting

Buenos Aires, C1111AAH, Argentina

Maffei Centro MédicoNot yet recruiting

Buenos Aires, C1425, Argentina

Clínica de Nefrología Urología Y Enfermedades CardiovascularesNot yet recruiting

Santa Fe, 3000, Argentina

John Hunter HospitalRecruiting

New Lambton, New South Wales 2305, Australia

Concord Repatriation General HospitalRecruiting

New South Wales, New South Wales 2060, Australia

Royal North Shore Hospital-Reserve RoadRecruiting

St Leonards, New South Wales 2065, Australia

Westmead HospitalRecruiting

Westmead, New South Wales 2145, Australia

Townsville HospitalRecruiting

Douglas, Queensland 4814, Australia

Royal Brisbane & Women's HospitalRecruiting

Herston, Queensland 4029, Australia

Gold Coast University HospitalRecruiting

Southport, Queensland 4215, Australia

Griffith UniversityRecruiting

Southport, Queensland 4222, Australia

Princess Alexandra HospitalRecruiting

Woolloongabba, Queensland 4102, Australia

Sunshine Hospital - AustraliaRecruiting

St Albans, Victoria 3021, Australia

Hôpital Erasme - PPDSRecruiting

Anderlecht, Brussels Capital 1070, Belgium

ZOL Genk - campus Sint-JanNot yet recruiting

Genk, Limburg 3600, Belgium

UZ Leuven - PPDSRecruiting

Leuven, Vlaams Brabant 3000, Belgium

Jan YpermanRecruiting

Ieper, West-Vlaanderen 8900, Belgium

AZ GroeningeRecruiting

Kortrijk, West-Vlaanderen 8500, Belgium

Cliniques Universitaires Saint-LucRecruiting

Brussels, 1200, Belgium

Freire Pesquisa ClínicaRecruiting

Belo Horizonte, Minas Gerais 30150-320, Brazil

Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDSRecruiting

Belo Horizonte, Minas Gerais 30150221, Brazil

Centro Mineiro de Pesquisa - CMiPRecruiting

Juiz de Fora, Minas Gerais 36010, Brazil

Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em SaúdeRecruiting

Caxias do Sul, Rio Grande do Sul 95070-560, Brazil

Hospital de Clinicas de Porto Alegre (HCPA) - PPDSRecruiting

Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Hospital Alemao Oswaldo Cruz- HAOCRecruiting

São Paulo, 01323-903, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting

São Paulo, 05403-000, Brazil

Medical Center Medconsult Pleven - Lovech BranchRecruiting

Lovech, 5500, Bulgaria

Medical Center Hera EOOD, Montana - Hera Clinics - PPDSRecruiting

Montana, 3400, Bulgaria

Medical Center Medconsult Pleven OODRecruiting

Pleven, 5800, Bulgaria

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov BlvdRecruiting

Sofia, 1606, Bulgaria

St Paul's HospitalRecruiting

Vancouver, British Columbia V6Z 1Y6, Canada

McGill University Health Centre (MUHC)Recruiting

Montreal, Quebec H4A3J1, Canada

Fu Yang People's Hospital - South CampusRecruiting

Fuyang, Anhui 236000, China

The First Affiliated Hospital of Anhui Medical University - Jixilu CampusRecruiting

Hefei, Anhui 230022, China

Peking University First Hospital - Changqiao CampusRecruiting

Beijing, Beijing Municipality 100034, China

Beijing Tsinghua Changgung HospitalRecruiting

Beijing, Beijing Municipality 102218, China

Fujian Medical University Union HospitalRecruiting

Fuzhou, Fujian 350001, China

Zhongshan Hospital Xiamen UniversityRecruiting

Xiamen, Fujian 361004, China

Gansu Provincial HospitalRecruiting

Lanzhou, Gansu 730000, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University - North CampusRecruiting

Guangzhou, Guangdong 510120, China

The First Affiliated Hospital of Guangzhou Medical University - Yanjiang CampusRecruiting

Guangzhou, Guangdong 510120, China

Shenzhen Hospital of Southern Medical UniversityRecruiting

Shenzhen, Guangdong 510086, China

Peking University Shenzhen HospitalRecruiting

Shenzhen, Guangdong 518036, China

Zhongshan Hospital of Traditional Chinese MedicineRecruiting

Zhongshan, Guangdong 528401, China

The First Affiliated Hospital of Guangxi Medical UniversityRecruiting

Nanning, Guangxi 530021, China

The People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting

Nanning, Guangxi 530021, China

Guizhou Provincial People's HospitalRecruiting

Guiyang, Guiyang 550000, China

The Affiliated Hospital of Guizhou Medical UniversityRecruiting

Guiyang, Guizhou 550000, China

Cangzhou Central HospitalRecruiting

Cangzhou, Hebei 61011, China

The Second Hospital of Hebei Medical University - MainRecruiting

Shijiazhuang, Hebei 50000, China

The Third Hospital of Hebei Medical UniversityRecruiting

Shijiazhuang, Hebei 50000, China

Daqing Oilfield General HospitalRecruiting

Daqing, Heilongjiang 163001, China

The First Affiliated Hospital of Henan Science and Technology University - Jinghua CampusRecruiting

Luoyang, Henan 471003, China

Prince of Wales Hospital - Hong KongRecruiting

Hong Kong, Hong Kong 999077, China

Queen Mary Hospital PPDSRecruiting

Hong Kong, Hong Kong 999077, China

Tung Wah HospitalRecruiting

Hong Kong, Hong Kong 999077, China

Renmin Hospital of Wuhan University - Main CampusRecruiting

Wuhan, Hubei 430223, China

Yichang Central People's Hospital - Wujiagang CampusRecruiting

Yichang, Hubei 443003, China

The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting

Nanjing, Jiangsu 210011, China

Affiliated Hospital of Nantong UniversityRecruiting

Nantong, Jiangsu 226001, China

Wuxi Peoples HospitalRecruiting

Wuxi, Jiangsu 214023, China

Qilu Hospital of Shandong UniversityRecruiting

Jinan, Shandong 250012, China

The Second Hospital of Shandong UniversityRecruiting

Jinan, Shandong 250033, China

Yantai Yuhuangding HospitalNot yet recruiting

Yantai, Shandong 264000, China

Zhongshan Hospital Fudan UniversityRecruiting

Shanghai, Shanghai Municipality 200023, China

Huashan Hospital Fudan University - PPDSRecruiting

Shanghai, Shanghai Municipality 200040, China

Shanghai General Hospital - North CampusRecruiting

Shanghai, Shanghai Municipality 200080, China

Jiading Central HospitalRecruiting

Shanghai, Shanghai Municipality 201899, China

Sichuan Academy of Medical Sciences & Sichuan Provincial People's HospitalRecruiting

Chengdu, Sichuan 610072, China

Jinhua Municipal Central HospitalRecruiting

Jinhua, Zhejiang 321000, China

Taizhou Hospital of Zhejiang Province - MainRecruiting

Taizhou, Zhejiang 317000, China

Clinica de la Costa S.A.S. - PPDSRecruiting

Barranquilla, Atlántico 80020, Colombia

Fundacion Santa Fe de Bogota - Calle 119 A No. 7 - 49Recruiting

Bogotá, Bogota D.C. 110231, Colombia

Hospital Universitario San IgnacioRecruiting

Bogotá, Cundinamarca 110231, Colombia

Healthy Medical Center S.A.S.Recruiting

Zipaquirá, Cundinamarca 250252, Colombia

Fundacion Valle Del LiliRecruiting

Cali, Valle del Cauca Department 760032, Colombia

Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29Recruiting

Zagreb, City of Zagreb 10000, Croatia

Polyclinic BonifarmRecruiting

Zagreb, City of Zagreb 10000, Croatia

Clinical Hospital Center RijekaRecruiting

Rijeka, 51000, Croatia

Special Hospital MedicoRecruiting

Rijeka, 51000, Croatia

Vseobecna Fakultni Nemocnice V PrazeRecruiting

Prague, Prague 128 08, Czechia

Institut klinicke a experimentalni medicinyRecruiting

Prague, Praha, Hlavní Mesto 140 21, Czechia

CHU de Strasbourg - Nouvel Hôpital CivilRecruiting

Strasbourg, Bas-Rhin 67091, France

CHU de BesançonRecruiting

Besançon, Dobus 25000, France

CHU de Bordeaux - Hôpital PellegrinRecruiting

Bordeaux, Gironde 33076, France

CHU de Reims - Hôpital Maison BlancheRecruiting

Reims, Grand Est 51092, France

GHRMSA - Hôpital Emile MullerRecruiting

Mulhouse, Haut-Rhin 68100, France

Hopital FochRecruiting

Suresnes, Hauts-de-Seine 92150, France

CHRU d'Orleans- Hôpital de La SourceRecruiting

Orléans, Loiret 45067, France

CHU de Nîmes - Hopital Universitaire CaremeauRecruiting

Nîmes Cédex 9, Occitanie 30929, France

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+33779058852

AP-HP - Hôpital Henri MondorRecruiting

Créteil, Val-de-Marne 94000, France

Centre Hospitalier Departemental de VendeeRecruiting

La Roche-sur-Yon, Vendée 85925, France

CHU Amiens Picardie - Site SudRecruiting

Dreuil-lès-Amiens, 80470, France

AP-HP - Hôpital Saint-LouisRecruiting

Paris, 75010, France

AP-HP - Hopital TenonRecruiting

Paris, 75020, France

Universitätsklinikum HeidelbergRecruiting

Heidelberg, Baden-Wurttemberg 69120, Germany

Nephrologisches Zentrum Villingen-SchwenningenRecruiting

Villingen-Schwenningen, Baden-Wurttemberg 78052, Germany

Universitätsklinikum Frankfurt, Apotheke Haus 19Recruiting

Frankfurt am Main, Hesse 60596, Germany

Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting

Mainz, Rhineland-Palatinate 55131, Germany

Universitätsklinikum Carl Gustav Carus an der TU DresdenRecruiting

Dresden, Saxony 1307, Germany

Universitätsklinikum LeipzigRecruiting

Leipzig, Saxony 4103, Germany

Charité - Universitätsmedizin BerlinRecruiting

Berlin, 10117, Germany

University General Hospital of PatrasRecruiting

Pátrai, Achaïa 26500, Greece

General Hospital of Athens ''G. Gennimatas''Recruiting

Athens, Attica 115 27, Greece

General Hospital of Athens ''Hippokratio''Recruiting

Athens, Attica 115 27, Greece

Laiko General Hospital of AthensRecruiting

Athens, Attica 11527, Greece

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARARecruiting

Chaïdári, Attica 12462, Greece

General Hospital of Heraklion VenizeleioRecruiting

Heraklion, Irakleio 714 09, Greece

PAGNI-University General Hospital of HeraklionRecruiting

Heraklion, Irakleio 715 00, Greece

University General Hospital of IoanninaRecruiting

Ioannina, 34098, Greece

AHEPA University General Hospital of ThessalonikiRecruiting

Thessaloniki, 54636, Greece

General Hospital of Thessaloniki ''G. Papanikolaou''Recruiting

Thessaloniki, 57010, Greece

Osmania General HospitalRecruiting

Hyderabad, Andhra Pradesh 500012, India

Nizams Institute of Medical SciencesRecruiting

Hyderabad, Andhra Pradesh 500082, India

All India Institute of Medical Sciences ( AIIMS ) - RaipurRecruiting

Raipur, Chhattisgarh 492099, India

Zydus HospitalRecruiting

Ahmedabad, Gujarat 380081, India

Muljibhai Patel Society for Research in Nephro-UrologyRecruiting

Nadiād, Gujarat 387001, India

Manipal Hospital BangaloreRecruiting

Bangalore, Karnataka 560017, India

M.S. Ramaiah Medical College and HospitalRecruiting

Bangalore, Karnataka 560054, India

Government Medical College, KozhikodeRecruiting

Kozhikode, Kerala 673008, India

Trivandrum Medical College HospitalNot yet recruiting

Trivandrum, Kerala 695011, India

Seth G S Medical College and K E M HospitalRecruiting

Mumbai, Maharashtra 400012, India

Noble HospitalRecruiting

Pune, Maharashtra 411013, India

Max Super Speciality Hospital - SaketRecruiting

New Delhi, National Capital Territory of Delhi 110017, India

Sir Ganga Ram HospitalRecruiting

New Delhi, National Capital Territory of Delhi 110060, India

King George Medical UniversityRecruiting

Lucknow, Uttar Pradesh 226003, India

Sanjay Gandhi Postgraduate Institute of Medical SciencesRecruiting

Lucknow, Uttar Pradesh 226014, India

Nil Ratan Sircar Medical College and HospitalRecruiting

Kolkata, West Bengal 700014, India

Postgraduate Institute of Medical Education & Research (PGIMER)Recruiting

Chandigarh, 160012, India

Azienda Ospedaliero Universitaria di ParmaRecruiting

Fontevivo, Emilia-Romagna 43010, Italy

Azienda Ospedaliero-Universitaria di Modena - Policlinico di ModenaRecruiting

Modena, Emilia-Romagna 41124, Italy

AUSL Piacenza - Ospedale Guglielmo da SalicetoRecruiting

Piacenza, Emilia-Romagna 29121, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di CattinaraRecruiting

Trieste, Friuli Venezia Giulia 34149, Italy

IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San MartinoNot yet recruiting

Genoa, Liguria 16132, Italy

ASST degli Spedali Civili di Brescia - Spedali Civili di BresciaRecruiting

Brescia, Lombardy 25123, Italy

Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele DaccòRecruiting

Ranica, Lombardy 24020, Italy

IRCCS Istituto Clinico HumanitasRecruiting

Rozzano, Lombardy 20089, Italy

Azienda Ospedaliero Universitaria Maggiore della CaritàWithdrawn

Novara, Piedmont 28100, Italy

ASL Città di Torino - Ospedale San Giovanni BoscoRecruiting

Turin, Piedmont 10154, Italy

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale NiguardaRecruiting

Florence, Tuscany 50134, Italy

Fujita Health University HospitalRecruiting

Toyoake-shi, Aiti 470-1192, Japan

Hirosaki University HospitalRecruiting

Hirosaki-shi, Aomori 036-8563, Japan

National Hospital Organization Chiba Medical Center Chibahigashi National HospitalRecruiting

Chiba, Chiba 260-8712, Japan

Juntendo University Urayasu HospitalRecruiting

Urayasu-Shi, Chiba 279-0021, Japan

Hokkaido University HospitalRecruiting

Sapporo, Hokkaido 060-8648, Japan

Hospital of the University of Occupational and Environmental Health, JapanRecruiting

Kitakyushu-shi, Hukuoka 807-8556, Japan

Fukushima Medical University HospitalRecruiting

Fukushima, Hukusima 960-1247, Japan

Toranomon Hospital KajigayaRecruiting

Kawasaki-shi, Kanagawa 213-0015, Japan

Kitasato University HospitalRecruiting

Sagamihara-shi, Kanagawa 252-0375, Japan

Yokohama City University HospitalRecruiting

Yokohama, Kanagawa 236-0004, Japan

University Hospital, Kyoto Prefectural University of MedicineRecruiting

Kyoto, Kyôto 602-8566, Japan

Tohoku Medical and Pharmaceutical University HospitalRecruiting

Sendai, Miyagi 983-8512, Japan

Nara Medical University HospitalRecruiting

Kashihara, Nara 634-8522, Japan

Kawasaki Medical School HospitalRecruiting

Kurashiki, Okayama-ken 701-0192, Japan

Hamamatsu University HospitalRecruiting

Hamamatsu, Sizouka 431-3192, Japan

Tokushima University HospitalRecruiting

Tokushima, Tokushima 770-8503, Japan

The Jikei University West Medical CenterRecruiting

Ashikaga-Shi, Tokyo 326-0843, Japan

Juntendo University HospitalRecruiting

Bunkyo-Ku, Tokyo 113-8431, Japan

Jikei University HospitalRecruiting

Minato-ku, Tokyo 105-8471, Japan

Showa Medical University HospitalRecruiting

Shinagawa-ku, Tokyo 142-86666, Japan

Ikeda Municipal HospitalRecruiting

Ikeda-shi, Ôsaka 563-8510, Japan

Osaka University HospitalRecruiting

Suita-shi, Ôsaka 565-0871, Japan

Hospital Tengku Ampuan AfzanRecruiting

Kuantan, Pahang 25100, Malaysia

Hospital Raja Permaisuri BainunRecruiting

Perak, Pahang 30450, Malaysia

University Malaya Medical CentreRecruiting

Lembah Pantai, WilayahPersekutuan KualaLumpur 59100, Malaysia

Auckland City HospitalRecruiting

Auckland, 1023, New Zealand

Aotearoa Clinical Trials Trust- Middlemore HospitalRecruiting

Auckland, 2025, New Zealand

Wellington HospitalRecruiting

Wellington, 6021, New Zealand

Norzel Medical and Diagnostic Clinic Foundation Corp.Recruiting

Cebu City, Cebu 6000, Philippines

The Medical City - Ortigas Ave - PPDSRecruiting

Pasig, Metropolitan Manila 1604, Philippines

MCM Krakow - PRATIA - PPDSRecruiting

Krakow, Lesser Poland Voivodeship 30727, Poland

SCM Clinic - Prywatny Szpital SpecjalistycznyRecruiting

Krakow, Lesser Poland Voivodeship 31-559, Poland

SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251Recruiting

Lodz, Lódzkie 92-213, Poland

Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7Recruiting

Gdansk, Pomeranian Voivodeship 80-952, Poland

Twoja Przychodnia - Szczecinskie Centrum MedyczneRecruiting

Szczecin, West Pomeranian Voivodeship 71-434, Poland

Uniwersytecki Szpital Kliniczny Nr 2 PUM w SzczecinieRecruiting

Szczecin, 70-110, Poland

ULS de Lisboa Ocidental, EPE - Hospital Santa CruzRecruiting

Carnaxide, Lisbon District 2790, Portugal

ULS de Gaia/Espinho, EPE - Unidade IRecruiting

Vila Nova de Gaia, Lisbon District 4434-502, Portugal

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351227865100

ULS da Região de Aveiro, EPE - Hospital Infante D. PedroRecruiting

Aveiro, 3814, Portugal

Centro Clínico Académico, Braga - Hospital de BragaRecruiting

Braga, 4710-243, Portugal

ULS de Coimbra, EPE - Hospitais da Universidade de CoimbraRecruiting

Coimbra, 3004-561, Portugal

ULS da Região de Leiria, EPE - Hospital de Santo AndréRecruiting

Leiria, 2410-197, Portugal

ULS da Arrábida, EPE - Hospital de São BernardoRecruiting

Setúbal, 2910-446, Portugal

FDI Clinical ResearchRecruiting

San Juan, 00927, Puerto Rico

Pusan National University HospitalRecruiting

Busan, Gwangyeogsi 49241, South Korea

Hallym University Sacred Heart HospitalRecruiting

Anyang-si, Gyeonggido 14068, South Korea

Seoul National University Bundang HospitalRecruiting

Seongnam-si, Gyeonggido 13620, South Korea

Ajou University HospitalRecruiting

Suwon, Gyeonggido 16499, South Korea

Severance Hospital Yonsei University Health SystemRecruiting

Seoul, Seoul Teugbyeolsi 3722, South Korea

Hanyang University Seoul HospitalRecruiting

Seoul, Seoul Teugbyeolsi 4763, South Korea

Inje University Haeundae Paik HospitalRecruiting

Busan, 48108, South Korea

Seoul National University HospitalRecruiting

Seoul, 03080, South Korea

Samsung Medical CenterRecruiting

Seoul, 6351, South Korea

Fundacio PuigvertRecruiting

Viladecans, Barcelona 8840, Spain

Hospital del MarRecruiting

Barcelona, Catalonia 8003, Spain

Hospital Universitario A CoruñaRecruiting

A Coruña, Galicia 15006, Spain

Hospital Universitario Fundacion AlcorconRecruiting

Alcorcón, Madrid 28922, Spain

Hospital Universitario de GetafeRecruiting

Getafe, Madrid 10400, Spain

Hospital Universitario Vall d'Hebron - PPDSRecruiting

Barcelona, 8035, Spain

Hospital General San Pedro de AlcantaraRecruiting

Cáceres, 10003, Spain

Hospital Universitari de Girona Dr Josep TruetaRecruiting

Girona, 17007, Spain

Hospital Universitario Fundacion Jimenez DiazRecruiting

Madrid, 28040, Spain

Hospital Universitario 12 de OctubreRecruiting

Madrid, 28041, Spain

Hospital Universitario Virgen MacarenaRecruiting

Seville, 41009, Spain

Hospital Universitario Miguel ServetRecruiting

Zaragoza, 50009, Spain

National Cheng Kung University HospitalRecruiting

Dawan, Taiwan, Province of China 70403, Taiwan

Far Eastern Memorial HospitalRecruiting

New Taipei City, Taiwan, Province of China 220216, Taiwan

China Medical University Hospital - PPDSRecruiting

Taichung, Taiwan, Province of China 40447, Taiwan

Mackay Memorial Hospital-Taipei branchRecruiting

Taipei, Taiwan, Province of China 104449, Taiwan

Taipei Municipal Wanfang HospitalRecruiting

Taipei, Taiwan, Province of China 116081, Taiwan

Chang Gung Memorial Hospital, LinkouRecruiting

Taoyuan, Taiwan, Province of China 33305, Taiwan

Kaohsiung Medical University - Chung-Ho Memorial HospitalRecruiting

Kaohsiung City, 807, Taiwan

Taipei Medical University Shuang Ho HospitalRecruiting

New Taipei City, 235041, Taiwan

Kocaeli Universitesi Arastirma ve Uygulama HastanesiRecruiting

İzmit, Kocaeli 41380, Turkey (Türkiye)

Ankara Bilkent Sehir HastanesiRecruiting

Ankara, Turkey 34899, Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma HastanesiRecruiting

Istanbul, Turkey 34899, Turkey (Türkiye)

Mehmet Akif Inan Egitim ve Arastirma HastanesiRecruiting

Sanliurfa, Turkey 63040, Turkey (Türkiye)

Akdeniz University Medical FacultyRecruiting

Antalya, 7070, Turkey (Türkiye)

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi HastanesiRecruiting

Istanbul, 34098, Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi Gevher Nesibe HastanesiRecruiting

Kayseri, 38039, Turkey (Türkiye)

Necmettin Erbakan Universitesi Meram Tip Fakultesi HastanesiRecruiting

Konya, 42090, Turkey (Türkiye)

St Pancras Clinical ResearchRecruiting

London, Greater London EC2Y 8EA, United Kingdom

Royal Preston Hospital - NWCRN- PPDSRecruiting

Preston, Lancashire PR2 9HT, United Kingdom

Leicester General HospitalRecruiting

Leicester, Leicestershire LE5 4PW, United Kingdom

Northern General HospitalRecruiting

Sheffield, South Yorkshire S5 7AU, United Kingdom

Royal Stoke University HospitalRecruiting

Stoke-on-Trent, Staffordshire ST4 6QG, United Kingdom