Clinical Trial: PALIZADE
Condition
Lupus Nephritis
Overview
The PALIZADE clinical trial will evaluate zetomipzomib as a potential new treatment for adults living with lupus nephritis. Kezar Life Sciences is conducting this trial to assess zetomipzomib for the treatment of lupus nephritis, its side effects, and how it affects proteins in the urine. Zetomipzomib is a first-in-class, investigational product being studied for the treatment of autoimmune diseases, including lupus nephritis, a serious complication of systemic lupus erythematosus. Zetomipzomib acts by inhibiting the immunoproteasome, a structure found in immune cells that helps to regulate the normal functioning of the immune system.
Participation Eligibility
Key Inclusion Criteria:
- Must be at least 18 years of age
- Have a kidney biopsy completed within the last year showing a clinical diagnosis of active lupus nephritis (Class III or IV, with or without Class V, or Class V alone). If you have not had a biopsy in the past year, you will need to complete a biopsy during the screening period for participation in the clinical trial
- Urine protein to creatinine ratio (UPCR) ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V)
- Have a body mass index (BMI) of ≥18 kg/m2
- Positive ANA test result and/or a positive anti-dsDNA serum antibody test
- Adequate hematologic, liver, and kidney function based on necessary lab results
- Must be willing to take steroids and mycophenolate mofetil or equivalent
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