A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE) (NCT05781750) | Clinical Trial Compass
TerminatedPhase 2
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
Stopped: Sponsor Decision.
United States, Argentina84 participantsStarted 2023-11-03
Plain-language summary
The purpose of this study was to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Body mass index of ≥18 kg/m\^2
* eGFR ≥30 mL/min/1.73 m\^2
* 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
Key Exclusion Criteria:
* 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
* Has received dialysis within the 52 weeks prior to Screening
* Positive test at Screening for HIV, hepatitis B/C
* Known intolerance to MMF or equivalent and corticosteroids
What they're measuring
1
Proportion of Patients Achieving Complete Renal Response