CTRI/2023/12/060561
Recruiting
Phase 2
A Phase 2b, Randomized, Controlled Double-blind,Multicenter Study Comparing the Efficacy and Safety ofZetomipzomib (KZR-616) 30 mg or 60 mg with Placeboin Patients with Active Lupus Nephritis - PALIZADE
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
- Sponsor
- Kezar Life Sciences, Inc.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index of \= 18 kg/m2 (m square)
- •eGFR \= 30 mL/min/1\.73 m2 (m square)
- •\-Unequivocally positive ANA test result and/or a positive anti\-dsDNA serum antibody test
- •\-Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
- •\-UPCR \=1\.0 (Class III/IV \+/\-V) or UPCR \=2\.0 (Class V)
- •\-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
- •4\) Known intolerance to MMF or equivalent and corticosteroids
Outcomes
Primary Outcomes
Not specified
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