Phase
Condition
Lupus Nephritis
Kidney Disease
Nephritis
Treatment
Felzartamab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1
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)
If eGFR is ≥35 to <45 mL/min/1.73m^2, renal biopsy must be within 6 months ofscreening and must not have >50% of glomeruli with sclerosis. If the renalbiopsy was performed more than 6 months prior to screening, a repeat biopsymust be done during screening after all the other eligibility criteria are met
If eGFR is ≥45 mL/min/1.73 m^2, renal biopsy must be within 1 year prior toscreening. If the renal biopsy was performed more than 1 year prior toscreening, a repeat biopsy must be done during screening after all the othereligibility criteria are met
- 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
Part 2
- Participants must complete Part 1 of the study to be eligible to participate in Part
Exclusion
Exclusion Criteria:
Part 1
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
Part 2
Did not complete Part 1 of the study
Received protocol-prohibited medications in Part 1 such as calcineurin inhibitors (e.g., cyclosporine, tacrolimus, or voclosporin), alkylating agents includingcyclophosphamide, or biologic agents other than felzartamab
Progression of LN (as measured by worsening proteinuria and/or decreasing eGFR) hasbeen observed such that in the opinion of the investigator the participant will notbenefit from continuing in Part 2 of the study
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 11201
United StatesSite Not Available
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
R & H Clinical Research
Katy, Texas 77450
United StatesActive - Recruiting
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