Education and Training
A Study of Felzartamab in Participants With Lupus Nephritis
The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Felzartamab
Eligibility
Inclusion Criteria:
- Diagnosis of Systemic Lupus Erythematosus (SLE) according to the 2019 European League
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 prior to
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 by the
Chronic Kidney Disease Epidemiology Collaboration formula)
- History of inadequate response, for lack of efficacy or intolerance, to at least a
three-month course of one standard of care treatment for lupus nephritis, as
determined by the treating physician
Exclusion Criteria:
- Presence of rapidly progressive glomerulonephritis, as defined by at least one of the
following: crescent formation in > 50% of glomeruli on renal biopsy, sustained
doubling of serum creatinine within 12 weeks of screening, or the investigator's
opinion 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 require
dialysis during the study treatment period
- A previous kidney transplant or other organ transplant, or planned transplant within
study treatment period
Other protocol-defined inclusion/exclusion criteria may apply
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elizabeth Chen
(650) 721-3848
I'm interested