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NCT06291376Active, not recruitingPhase 3

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
584 (actual)
First submitted
26 Feb 2024
Start date
29 Mar 2024
Primary completion date
5 Jan 2026
Lead sponsor
Alexion Pharmaceuticals, Inc.
NCT number
NCT06291376
EU CT number
2023-507851-31-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 584
  • From 29 Mar 2024 to the primary completion date, 5 Jan 2026
  • 226 sites in 29 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

  • Concomitant clinically significant renal disease other than IgAN.
  • Prior use of immunosuppressive treatment within 3 months of screening.
  • Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.

Other illness

  • Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
  • History of kidney transplant or planned kidney transplant during the Treatment Period.
  • History of Neisseria meningitidis infection.

Lab values

  • Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
  • Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8.5%.

Other

  • Splenectomy or functional asplenia.

Who the study is looking for

  • Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m\^2.
  • For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
  • UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
  • Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
  • Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
  • Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 106.

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

Full criteria on ClinicalTrials.gov

Sites (226)

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

SiteCityCountrySite status
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Ciudad de Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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La PlataArgentinaUnknown status
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RosarioArgentinaUnknown status
Medical University of Graz
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GrazAustriaActive, not recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
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CanberraAustraliaUnknown status
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ClaytonAustraliaUnknown status
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ConcordAustraliaUnknown status
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HerstonAustraliaUnknown status
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LiverpoolAustraliaUnknown status
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PerthAustraliaUnknown status
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SouthportAustraliaUnknown status
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St AlbansAustraliaUnknown status
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
UZ Brussel
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JetteBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
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Belo HorizonteBrazilUnknown status
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BotucatuBrazilUnknown status
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CuritibaBrazilUnknown status
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FortalezaBrazilUnknown status
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RecifeBrazilUnknown status
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Ribeirão PretoBrazilUnknown status
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São José do Rio PretoBrazilUnknown status
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São PauloBrazilUnknown status
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BramptonCanadaUnknown status
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LondonCanadaUnknown status
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TorontoCanadaUnknown status
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WinnipegCanadaUnknown status
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AraucaniaChileUnknown status
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ProvidenciaChileUnknown status
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SantiagoChileUnknown status
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ValdiviaChileUnknown status
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BaotouChinaUnknown status
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BeijingChinaUnknown status
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ChangshaChinaUnknown status
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ChangzhouChinaUnknown status
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ChengduChinaUnknown status
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ChongqingChinaUnknown status
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GuangzhouChinaUnknown status
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HangzhouChinaUnknown status
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JinanChinaUnknown status
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JinhuaChinaUnknown status
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LanzhouChinaUnknown status
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LuoyangChinaUnknown status
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NanchangChinaUnknown status
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NanjingChinaUnknown status
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NingboChinaUnknown status
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QingdaoChinaUnknown status
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ShanghaiChinaUnknown status
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ShenzhenChinaUnknown status
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ÜrümqiChinaUnknown status
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WuhanChinaUnknown status
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WuxiChinaUnknown status
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Xi'anChinaUnknown status
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YantaiChinaUnknown status
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YibinChinaUnknown status
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YinchuanChinaUnknown status
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ZhengzhouChinaUnknown status
Nemocnice AGEL Nový Jičín a.s.
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Nový JičínCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Institute for Clinical and Experimental Medicine
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PragueCzechiaActive, not recruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Universitaetsklinikum Erlangen AöR
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ErlangenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyActive, not recruiting
Medizinische Hochschule Hannover
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HanoverGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Muenchner Studienzentrum
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MunichGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Hospital Universitario Principe de Asturias
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Alcalá de HenaresSpainActive, not recruiting
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Infanta Leonor
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitari Joan XXIII de Tarragona
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TarragonaSpainActive, not recruiting
Hospital Unviersitario Miguel Servet
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ZaragozaSpainActive, not recruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceActive, not recruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceActive, not recruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceActive, not recruiting
Centre Hospitalier Métropole Savoie
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ChambéryFranceActive, not recruiting
Chu Gabriel Montpied
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Clermont-FerrandFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceActive, not recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
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CambridgeUnited KingdomUnknown status
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DoncasterUnited KingdomUnknown status
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LeicesterUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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ReadingUnited KingdomUnknown status
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StevenageUnited KingdomUnknown status
Laiko General Hospital of Athens
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AthensGreeceActive, not recruiting
Hippokration Hospital
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AthensGreeceActive, not recruiting
University General Hospital Attikon
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AthensGreeceActive, not recruiting
University General Hospital of Heraklion
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HeraklionGreeceActive, not recruiting
General University Hospital Of Patras
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PatrasGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
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Hong KongHong Kong SAR ChinaUnknown status
Semmelweis University
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Budapest VIIIHungaryCompleted
TritonLife Dializis Center Kft.
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MiskolcHungaryCompleted
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HaifaIsraelUnknown status
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JerusalemIsraelUnknown status
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NazarethIsraelUnknown status
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Petah TikvaIsraelUnknown status
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Tel AvivIsraelUnknown status
Ospedale San Giovanni di Dio
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AgrigentoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
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BariItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyActive, not recruiting
ARNAS G. Brotzu
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CagliariItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedale Universita Padova
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PadovaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyActive, not recruiting
Azienda Unita Sanitaria Locale Di Piacenza
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PiacenzaItalyActive, not recruiting
Azienda Sanitaria Locale Citta Di Torino
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TurinItalyActive, not recruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyActive, not recruiting
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Bunkyō CityJapanUnknown status
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ChibaJapanUnknown status
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FukuokaJapanUnknown status
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KamakuraJapanUnknown status
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Kasugai-shiJapanUnknown status
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Kitakyushu-shiJapanUnknown status
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KobeJapanUnknown status
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Matsumoto-shiJapanUnknown status
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MatsuyamaJapanUnknown status
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NagoyaJapanUnknown status
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OsakaJapanUnknown status
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SapporoJapanUnknown status
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Urayasu-shiJapanUnknown status
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Anyang-siSouth KoreaUnknown status
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BusanSouth KoreaUnknown status
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DeaguSouth KoreaUnknown status
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GwangjuSouth KoreaUnknown status
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Gyeonggi-doSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SuwonSouth KoreaUnknown status
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IpohMalaysiaUnknown status
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Johor BahruMalaysiaUnknown status
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Kuala LumpurMalaysiaUnknown status
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SerembanMalaysiaUnknown status
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Radboud Universitair Medisch Centrum (Radboudumc)
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NijmegenNetherlandsActive, not recruiting
Sint Franciscus Vlietland Groep Stichting
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RotterdamNetherlandsActive, not recruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandActive, not recruiting
Promed P.Lach R.Glowacki Sp. j.
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CracowPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandActive, not recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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LublinPolandActive, not recruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Szpital Kliniczny Dzieciątka
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WarsawPolandActive, not recruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandActive, not recruiting
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DammamSaudi ArabiaUnknown status
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JeddahSaudi ArabiaUnknown status
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RiyadhSaudi ArabiaUnknown status
F D Roosevelt University General Hospital Of Banska Bystrica
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Banska BystricaSlovakiaActive, not recruiting
University Hospital Bratislava
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BratislavaSlovakiaActive, not recruiting
Univerzitna nemocnica L. Pasteura Kosice
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Kosice - ZapadSlovakiaActive, not recruiting
Univerzitna nemocnica Martin
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MartinSlovakiaActive, not recruiting
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BangkokThailandUnknown status
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Chiang MaiThailandUnknown status
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Khon KaenThailandUnknown status
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Kaohsiung CityTaiwanUnknown status
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New Taipei CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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TaoyuanTaiwanUnknown status
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AcworthUnited StatesUnknown status
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AlabasterUnited StatesUnknown status
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AlbanyUnited StatesUnknown status
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ArlingtonUnited StatesUnknown status
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AtlantaUnited StatesUnknown status
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Bay PinesUnited StatesUnknown status
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BostonUnited StatesUnknown status
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CharlottesvilleUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
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KnoxvilleUnited StatesUnknown status
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LawrencevilleUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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MiamiUnited StatesUnknown status
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MilwaukeeUnited StatesUnknown status
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MinneapolisUnited StatesUnknown status
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New OrleansUnited StatesUnknown status
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New YorkUnited StatesUnknown status
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North Las VegasUnited StatesUnknown status
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OrangeUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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PhoenixUnited StatesUnknown status
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San AntonioUnited StatesUnknown status
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San BernardinoUnited StatesUnknown status
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San DiegoUnited StatesUnknown status
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San FranciscoUnited StatesUnknown status
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ShenandoahUnited StatesUnknown status
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StanfordUnited StatesUnknown status
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The BronxUnited StatesUnknown status
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TorranceUnited StatesUnknown status
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ValenciaUnited StatesUnknown status
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WorcesterUnited StatesUnknown status
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AnkaraTurkey (Türkiye)Unknown status
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KayseriTurkey (Türkiye)Unknown status
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KonyaTurkey (Türkiye)Unknown status

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