A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
Megadott ok: Sponsor Decision.
Key facts
- Where
- Ahmedabad, Chhatrapati Sambhajinagar, Hyderabad, Jaipur, Nagpur, Nashik, New Delhi, Raipur, Secunderabad, Surat és Thrissur, IndiaSee the 13 sites
- Phase
- 2. fázis
Where in India
- Panchshil HospitalAhmedabad, IndiaNo longer taking part
- MGM Medical College and HospitalChhatrapati Sambhajinagar, IndiaNo longer taking part
- Yashoda HospitalsHyderabad, IndiaNo longer taking part
- SMS Medical CollegeJaipur, IndiaNo longer taking part
- Jasleen HospitalNagpur, IndiaNo longer taking part
- Kingsway HospitalNagpur, IndiaNo longer taking part
- Assured Care Plus HospitalNashik, IndiaNo longer taking part
- Sir Ganga Ram HospitalNew Delhi, IndiaNo longer taking part
- All India Institute of Medical SciencesRaipur, IndiaNo longer taking part
- Krishna Institute Of Medical ScienceSecunderabad, IndiaNo longer taking part
- Nirmal HospitalSurat, IndiaNo longer taking part
- Unity HospitalSurat, IndiaNo longer taking part
- Elite Mission HospitalThrissur, IndiaNo longer taking part
Trial details
- Who runs it
- Kezar Life Sciences, Inc.
- Trial code
- NCT05781750
- Record updated
- 2025. december 5.
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Has received dialysis within the 52 weeks prior to Screening; Known intolerance to MMF or equivalent and corticosteroids; Positive test at Screening for HIV, hepatitis B/C; 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.