PER-028-23
Not yet recruiting
Phase 2
A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- M321 Systemic lupus erythematosus with organ or system involvement
- Sponsor
- Kezar Life Sciences, Inc.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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