A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zetomipzomib in Patients with Active Lupus Nephritis
- Conditions
- M321 Systemic lupus erythematosus with organ or system involvementSystemic lupus erythematosus with organ or system involvementM321
- Registration Number
- PER-028-23
- Lead Sponsor
- Kezar Life Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without starting enrollment
- Sex
- All
- Target Recruitment
- 0
1.Is able to provide written informed consent before any study-related procedures are performed.
2.Is aged =18 years at the time of signing the informed consent.
3.Has a body mass index of =18 kg/m2.
4.eGFR =30 mL/min/1.73 m^2
5.Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
6.Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
7.UPCR =1.0 (Class III/IV +/-V) or UPCR =2.0 (Class V)
8.Adequate hematologic, hepatic, and renal function
1.Current or medical history of:
•Central nervous system manifestations of SLE
•Overlapping autoimmune condition that may affect study assessments/outcomes
•Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
•Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions
•Solid organ transplant or planned transplant during study
•Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers >5 years ago
2.Has received dialysis within the 52 weeks prior to Screening
3.Positive test at Screening for HIV, hepatitis B/C Known intolerance to MMF or equivalent and corticosteroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method