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Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy
Sponsor: HI-Bio, A Biogen Company
Summary
Randomized, placebo-controlled, multi-center, double-blind, proof of concept phase IIa trial and dose evaluation trial of felzartamab in IgAN
Official title: A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2021-08-31
Completion Date
2024-05-06
Last Updated
2026-04-28
Healthy Volunteers
No
Conditions
Interventions
Felzartamab
anti-CD38+ monoclonal antibody
Placebo
Placebo comparator
Locations (59)
FOMAT Medical Research - FOMAT - HyperCore - PPDS
Oxnard, California, United States
Amicis Research Center, Vacaville
Vacaville, California, United States
Mayo Clinic Hospital - Methodist Campus
Rochester, Minnesota, United States
MedResearch INC
El Paso, Texas, United States
Core Research Group
Milton, Queensland, Australia
Sunshine Hospital - Australia
Saint Albans, Victoria, Australia
Imelda VZW
Bonheiden, Antwerpen, Belgium
UZ Leuven Hospital
Leuven, Vlaams Brabant, Belgium
Regionaal Ziekenhuis Jan Yperman VZW
Ieper, Belgium
CHU Sart Tilman Hospital
Liège, Belgium
Diagnostic- Consultative Center Convex EOOD
Sofia, Sofia-Grad, Bulgaria
Medical Center Hera EOOD, Montana
Montana, Bulgaria
Medical Center Hipokrat- N EOOD
Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment
Stara Zagora, Bulgaria
Nemocnice AGEL Novy Jicin a.s
Nový Jicín, Moravian-Silesian Region, Czechia
Eticka komise Fakultni nemocnice Olomouc
Olomouc, Olomouc Region, Czechia
Fakultni nemocnice Kralovske Vinohrady Hospital
Prague, Praha, Hlavní Mesto, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Praha, Hlavní Mesto, Czechia
JSC Evex Hospitals
Tbilisi, Georgia
L. Managadze National Center of Urology LTD
Tbilisi, Georgia
Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
Tbilisi, Georgia
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-Shi, Hukuoka, Japan
Kurume University Hospital
Kurume-Shi, Hukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Hukusima, Japan
JCHO Sendai Hospital
Sendai, Miyagi, Japan
Japanese Red Cross Ashikaga Hospital
Ashikaga-Shi, Tochigi, Japan
Juntendo University Hospital
Bunkyō-Ku, Tokyo, Japan
Osaka University Hospital
Suita-Shi, Ôsaka, Japan
University Malaya Medical Centre
Pantai, Malaysia
St Frances Cabrini Medical Center and Cancer Institute
Santo Tomas, Batangas, Philippines
Clinical Centre of Vojvodina
Novi Sad, Vojvodina, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia
Clinical Hospital Centar Zvezdara
Belgrade, Serbia
General Hospital Krusevac
Kruševac, Serbia
University Clinical Center Nis
Niš, Serbia
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, South Korea
Ajou University Hospital
Suwon, Gyeonggido, South Korea
Konkuk University Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Fundacio Puigvert
Badalona, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Hospital Ruber Juan Bravo (Grupo Quironsalud)
Madrid, Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council
Ternopil, Ternopil Oblast, Ukraine
Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"
Kyiv, Ukraine
State Institution Institute of Nephrology of NAMS of Ukraine
Kyiv, Ukraine
Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
Zaporizhzhia, Ukraine