Phase
Condition
Lupus Nephritis
Kidney Disease
Nephritis
Treatment
Felzartamab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 EuropeanLeague Against Rheumatism (EULAR)/ American College of Rheumatology (ACR) criteria
Diagnosis of International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 1 year priorto or during screening, either with or without the presence of Class V LN
Proteinuria (urine protein to creatinine ratio) > 1.0 gram per gram (g/g), based on 24-hour urine collection during screening
eGFR ≥ 45 milliliter/minute/1.73 square meters (mL/min/1.73 m^2) (as calculated bythe Chronic Kidney Disease Epidemiology Collaboration formula)
History of inadequate response, for lack of efficacy or intolerance, to at least athree-month course of one standard of care treatment for lupus nephritis, asdetermined by the treating physician
Exclusion
Exclusion Criteria:
Presence of rapidly progressive glomerulonephritis, as defined by at least one ofthe following: crescent formation in > 50% of glomeruli on renal biopsy, sustaineddoubling of serum creatinine within 12 weeks of screening, or the investigator'sopinion that the participant has rapidly progressive glomerulonephritis
Greater than 50% of glomeruli with sclerosis on renal biopsy
Currently requiring hemodialysis or peritoneal dialysis or expected to requiredialysis during the study treatment period
A previous kidney transplant or other organ transplant, or planned transplant withinstudy treatment period
Other protocol-defined inclusion/exclusion criteria may apply
Study Design
Study Description
Connect with a study center
Hospital Britanico de Buenos Aires
Caba, Capital Federal C1280AEB
ArgentinaActive - Recruiting
CEMIC
Caba, Ciudad Autonoma De Buenos Aires C1431FWO
ArgentinaActive - Recruiting
Clinica Priv Velez Sarsfield
Córdoba, Cordoba X5016
ArgentinaActive - Recruiting
HI-Bio Investigational Site
Córdoba, Cordoba X5016
ArgentinaActive - Recruiting
HI-Bio Investigational Site
Caba, C1431FWO
ArgentinaActive - Recruiting
HI-Bio Investigational Site
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Westmead Hospital
Westmead, New South Wales 2145
AustraliaActive - Recruiting
HI-Bio Investigational Site
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
HI-Bio Investigational Site
Clayton, Victoria 3168
AustraliaSite Not Available
Monash Health
Melbourne, Victoria 3168
AustraliaActive - Recruiting
HI-Bio Investigational Site
Saint Albans, Victoria 3021
AustraliaActive - Recruiting
Western Health
Saint Albans, Victoria 3021
AustraliaActive - Recruiting
HI-Bio Investigational Site
Vancouver, British Columbia V6Z1Y6
CanadaSite Not Available
St. Paul's Hospital
Vancouver, British Columbia V6Z1Y6
CanadaActive - Recruiting
HI-Bio Investigational Site
Toronto, Ontario MST258
CanadaSite Not Available
University Health Network - Toronto General Division
Toronto, Ontario MST258
CanadaActive - Recruiting
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montréal, Quebec H2X 3J4
CanadaActive - Recruiting
HI-Bio Investigational Site
Montréal, Quebec H2X 3J4
CanadaActive - Recruiting
Centro Integral en Reumatología S.A. de C.V.
Guadalajara, Jalisco 44160
MexicoSite Not Available
HI-Bio Investigational Site
Guadalajara, Jalisco 44160
MexicoSite Not Available
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ciudad de Mexico, Mexico City 14080
MexicoSite Not Available
HI-Bio Investigational Site
Mérida, Yucatan 97070
MexicoSite Not Available
Medical Care and Research S.A de C.V.
Mérida, Yucatan 97070
MexicoSite Not Available
HI-Bio Investigational Site
Chihuahua, 31210
MexicoSite Not Available
Servicios Avanzados de Investigación Médica/ Mediadvance Clinical S.C.
Chihuahua, 31210
MexicoSite Not Available
HI-Bio Investigational Site
Mexico City, 14080
MexicoSite Not Available
Centricity Research - Phoenix
Mesa, Arizona 85206
United StatesSite Not Available
HI-Bio Investigational Site
Mesa, Arizona 85206
United StatesSite Not Available
HI-Bio Investigational Site
La Jolla, California 92037
United StatesActive - Recruiting
University of California, San Diego (UCSD)
La Jolla, California 92037
United StatesActive - Recruiting
HI-Bio Investigational Site
San Francisco, California 94143
United StatesSite Not Available
University of California, San Francisco (UCSF)
San Francisco, California 94143
United StatesActive - Recruiting
HI-Bio Investigational Site
Stanford, California 94305
United StatesActive - Recruiting
Stanford University Medical Center
Stanford, California 94305
United StatesActive - Recruiting
ClinCept, LLC/River City Vascular Specialists LLC
Columbus, Georgia 31904
United StatesActive - Recruiting
HI-Bio Investigational Site
Columbus, Georgia 31904
United StatesActive - Recruiting
Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia 30046
United StatesActive - Recruiting
HI-Bio Investigational Site
Lawrenceville, Georgia 30046
United StatesActive - Recruiting
HI-Bio Investigational Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
HI-Bio Investigational Site
Brooklyn, New York 11203
United StatesActive - Recruiting
Joseph S. and Diane H. Steinberg Ambulatory Care Center
Brooklyn, New York 11201
United StatesSite Not Available
SUNY Downstate Medical Center
Brooklyn, New York 11203
United StatesActive - Recruiting
HI-Bio Investigational Site
Cleveland, Ohio 44106
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
The Ohio State University (OSU)
Columbus, Ohio 43210
United StatesActive - Recruiting
HI-Bio Investigational Site
Houston, Texas 77054
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
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