A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
NCT ID: NCT05781750
Last Updated: 2025-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
84 participants
INTERVENTIONAL
2023-11-03
2024-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)
NCT02176486
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
NCT02256150
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184
NCT01777256
Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
NCT02270970
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
NCT02514967
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients were required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis.
Patients were randomized in a 2:1 ratio to receive either zetomipzomib (30 mg or 60 mg) or placebo administered as a subcutaneous injection once weekly for 52 weeks, followed by a 4-week safety follow-up period. Efficacy was to be assessed by measuring the level of proteinuria (as measured by urine protein to creatinine ratio \[UPCR\]) and estimated glomerular filtration rate (eGFR) as compared to current standard of care treatment. Safety was also assessed throughout the study to ensure an acceptable safety profile.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
zetomipzomib 30 mg + standard-of-care
Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
zetomipzomib
Subcutaneous injection of zetomipzomib
zetomipzomib 60 mg + standard-of-care
Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
zetomipzomib
Subcutaneous injection of zetomipzomib
placebo + standard-of-care
Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
placebo
Subcutaneous injection of placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
zetomipzomib
Subcutaneous injection of zetomipzomib
placebo
Subcutaneous injection of placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kezar Life Sciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kezar
Role: STUDY_DIRECTOR
Kezar Life Sciences, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Accurate Clinical Research - Lake Charles
Lake Charles, Louisiana, United States
Nephrology Associates, Inc
East Providence, Rhode Island, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Prolato Clinical Research Center (PCRC)
Houston, Texas, United States
Mayo Clinic of UCMB SRL
San Miguel de Tucumán, Tucumán Province, Argentina
Framingham Medical Center
Buenos Aires, , Argentina
Medical Research Organization
Buenos Aires, , Argentina
Aprillus Assistance and Research by Arcis Health
Buenos Aires, , Argentina
Dr. Doreski Medical Offices
Buenos Aires, , Argentina
Military Central Hospital
Buenos Aires, , Argentina
Austral University Hospital
Pilar, , Argentina
Holy House of Mercy of Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Clinics Hospital FMRP
Ribeirão Preto, São Paulo, Brazil
Faculty of Medicine of SJRP
São José do Rio Preto, São Paulo, Brazil
Clinical Hospital FMUSP
São Paulo, , Brazil
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Costa Clinica
Barranquilla, Atlántico, Colombia
Laiko General Hospital of Athens
Athens, , Greece
Center for Advanced Health Clinical Studies
Guatemala City, , Guatemala
Clinical Research Center, S.A.
Guatemala City, , Guatemala
Medical Clinic Specialized in Internal Medicine and Rheumatology
Guatemala City, , Guatemala
Medical Clinic Specialized in Internal Medicine and Rheumatology
Guatemala City, , Guatemala
All India Institute of Medical Sciences
Raipur, Chhattisgarh, India
Nirmal Hospital
Surat, Guajrat, India
Unity Hospital
Surat, Guajrat, India
Panchshil Hospital
Ahmedabad, Gujarat, India
Elite Mission Hospital
Thrissur, Kerala, India
MGM Medical College and Hospital
Aurangabad, Maharashtra, India
Kingsway Hospital
Nagpur, Maharashtra, India
Jasleen Hospital
Nagpur, Maharashtra, India
Assured Care Plus Hospital
Nashik, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, NCT of Delhi, India
SMS Medical College
Jaipur, Rajasthan, India
Yashoda Hospitals
Hyderabad, Telangana, India
Krishna Institute of Medical Science
Secunderabad, Telangana, India
Prince Court Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Selayang
Batu Caves, Selangor, Malaysia
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Iloilo Doctors' Hospital
Iloilo City, Iloilo, Philippines
ManilaMed - Medical Center Manila
Manila, National Capital Region, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, Philippines
Far Eastern University Hospital Nicanor Reyes Medical Foundation
Quezon City, National Capital Region, Philippines
University of Santo Tomas Hospital
Manila, , Philippines
Phoenix Pharma
Port Elizabeth, Eastern Cape, South Africa
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Corporate website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KZR-616-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.