A Study of Zetomipzomib (KZR-616) in Patients with Active Lupus Nephritis (PALIZADE)
- Registration Number
- NCT05781750
- Lead Sponsor
- Kezar Life Sciences, Inc.
- Brief Summary
The purpose of this study is 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).
- Detailed Description
This study aims to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, is able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy will be mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids.
Patients are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis.
Patients will be 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 will 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 will also be assessed throughout the study to ensure an acceptable safety profile.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 84
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description zetomipzomib 30 mg + standard-of-care zetomipzomib Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period. zetomipzomib 60 mg + standard-of-care zetomipzomib Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period. placebo + standard-of-care placebo Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of zetomipzomib Baseline through Week 37 Proportion of patients achieving complete renal response (CRR), defined as:
* A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points)
* An eGFR ≥60 mL/min/1.73 m\^2 or no confirmed decrease of \>20% from Baseline eGFR.To evaluate safety of zetomipzomib Baseline through Week 56 Incidence and severity of adverse event (AE)s for each treatment group and patients treated with zetomipzomib compared with placebo
- Secondary Outcome Measures
Name Time Method Partial Renal Remission (PRR) Baseline through Week 25, Week 37, and Week 53 Proportion of patients achieving PRR, defined as:
* A ≥50% reduction of UPCR from Baseline, and to \<1.0 if the Baseline UPCR was \<3.0 or to \<3.0 if the Baseline value was ≥3.0.CRR Baseline through Week 25 and Week 53 Proportion of patients achieving CRR
Trial Locations
- Locations (182)
Nephrology Consultants, LLC
🇺🇸Huntsville, Alabama, United States
Southwest Kidney Institute
🇺🇸Surprise, Arizona, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc.
🇺🇸Los Alamitos, California, United States
Renal Specialists of Houston
🇺🇸Pasadena, Texas, United States
The Medical Institute of the Clinical Studies Foundation
🇦🇷Rosario, Santa Fe, Argentina
Mayo Clinic of UCMB SRL
🇦🇷San Miguel De Tucumán, Tucumán, 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
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Saint Marcelina Hospital
🇧🇷São Paulo, Brazil
Center for Advanced Health Clinical Studies
🇬🇹Guatemala, Guatemala
Clinical Research Center, S.A.
🇬🇹Guatemala, Guatemala
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Alma Mater Hospital of Antioquia
🇨🇴Medellín, Antioquia, Colombia
Costa Clinica
🇨🇴Barranquilla, Atlántico, Colombia
Healthy Medical Center S.A.S.
🇨🇴Zipaquirá, Cundinamarca, Colombia
Cardiovascular Foundation of Colombia
🇨🇴Bucaramanga, Santander, Colombia
IPS Julian Coronel Medical Center SAS
🇨🇴Cali, Valle de Cauca, Colombia
University Hospital of Split
🇭🇷Split, Croatia
Solmed Clinic
🇭🇷Zagreb, Croatia
University Hospital Center Zagreb
🇭🇷Zagreb, Croatia
Laiko General Hospital of Athens
🇬🇷Athens, Greece
University General Hospital of Larisa
🇬🇷Larisa, Greece
Ippokratio General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Medical Clinic Specialized in Internal Medicine and Rheumatology
🇬🇹Guatemala City, Guatemala
Medical Clinic Specialized in Nephrology
🇬🇹Guatemala, Guatemala
General Hospital Krusevac
🇷🇸Krusevac, Serbia
University Clinical Center Niš
🇷🇸Niš, Serbia
Phoenix Pharma
🇿🇦Port Elizabeth, Eastern Cape, South Africa
CRISMO Research Centre
🇿🇦Germiston, Gauteng, South Africa
Arthritis Clinical Trial Centre
🇿🇦Cape Town, Western Cape, South Africa
The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Reliant Medical Research
🇺🇸Miami, Florida, United States
Phoenix Research Center, LLC
🇺🇸Miami, Florida, United States
Elixia Central Florida
🇺🇸Orlando, Florida, United States
West Broward Rheumatology Associates, Inc.
🇺🇸Tamarac, Florida, United States
ClinCept Clinical Research
🇺🇸Columbus, Georgia, United States
Southeast Kidney Associates
🇺🇸East Point, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Accurate Clinical Research - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
Northwell Health
🇺🇸Great Neck, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Renal Associates
🇺🇸Langhorne, Pennsylvania, United States
Clinical Renal Associates, Ltd.
🇺🇸Upland, Pennsylvania, United States
Nephrology Associates, Inc
🇺🇸East Providence, Rhode Island, United States
Hypertension and Nephrology Inc
🇺🇸Providence, Rhode Island, United States
Texas Tech University Health Science Center
🇺🇸Amarillo, Texas, United States
Precision Comprehensive Clinical Research Solutions
🇺🇸Colleyville, Texas, United States
Texas Kidney Institute
🇺🇸Dallas, Texas, United States
Prolato Clinical Research Center (PCRC)
🇺🇸Houston, Texas, United States
North Texas Kidney Disease Associates
🇺🇸Lewisville, Texas, United States
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Wollongong Hospital
🇦🇺Wollongong, New South Wales, Australia
Gold Coast Hospital and Health Service
🇦🇺Southport, Queensland, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Specialized Rheumatology Services of Bahia
🇧🇷Salvador, Bahia, Brazil
Senhor de Bonfim Clinic
🇧🇷Salvador, Bahia, Brazil
L2IP - Clinical Research Institute
🇧🇷Brasília, Distrito Federal, Brazil
Brasília Hospital
🇧🇷Brasília, Federal District, Brazil
Hospital São Domingos
🇧🇷São Luís, Maranhão, Brazil
Holy House of Mercy of Belo Horizonte
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Pro-Renal Institute Brazil
🇧🇷Curitiba, Paraná, Brazil
LMK Medical Services SS
🇧🇷Porto Alegre, Rio Grande do Sol, Brazil
Hospital Association Clinical Research Center - Windmills Hospital
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Pro-Rim Foundation Research Center
🇧🇷Joinville, Santa Catarina, Brazil
Clinics Hospital FMRP
🇧🇷Ribeirão Preto, São Paulo, Brazil
Praxis Medical Research
🇧🇷Santo André, São Paulo, Brazil
Multidisciplinary Center for Clinical Studies
🇧🇷São Bernardo Do Campo, São Paulo, Brazil
Faculty of Medicine of SJRP
🇧🇷São José Do Rio Preto, São Paulo, Brazil
Hospital São Lucas Copacabana
🇧🇷Rio De Janeiro, Brazil
Hospital Nove de Julho
🇧🇷São Paulo, Brazil
Oswaldo Ramos Foundation
🇧🇷São Paulo, Brazil
Clinical Hospital FMUSP
🇧🇷São Paulo, Brazil
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The Fifth Hospital of Xiamen
🇨🇳Xiamen, Fujian, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Zhongshan Hospital of Traditional Chinese Medicine
🇨🇳Zhongshan, Guangdong, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Nanyang Central Hospital
🇨🇳Nanyang, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
China-Japan Union Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Binzhou Medical University Hospital
🇨🇳Binzhou, Shandong, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
🇨🇳Huangpu, Shanghai, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Mianyang Central Hospital
🇨🇳Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Sichuan, China
All India Institute of Medical Sciences
🇮🇳Raipur, Chhattisgarh, India
Nirmal Hospital
🇮🇳Surat, Guajrat, India
Unity Hospital
🇮🇳Surat, Guajrat, India
Panchshil Hospital
🇮🇳Ahmedabad, Gujarat, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belgaum, Karnataka, 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
Christian Medical College
🇮🇳Ranipet, Tamil Nadu, India
Yashoda Hospitals
🇮🇳Hyderabad, Telangana, India
Krishna Institute of Medical Science
🇮🇳Secunderabad, Telangana, India
Institute of Post Graduate Medical Education and Research / SSKM Hospital
🇮🇳Kolkata, West Bengal, India
Fortis Hospital
🇮🇳Kolkata, West Bengal, India
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Tengku Ampuan Afzan
🇲🇾Kuantan, Pahang, Malaysia
Hospital Raja Permaisuri Bainun
🇲🇾Ipoh, Perak, Malaysia
Hospital Selayang
🇲🇾Batu Caves, Selangor, Malaysia
Hospital Sultan Idris Shah Serdang
🇲🇾Kajang, Selangor, Malaysia
Prince Court Medical Centre
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
Hospital Canselor Tuanku Muhriz UKM
🇲🇾Kuala Lumpur, Wilayah Persekutuan, Malaysia
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Hospital Al Sultan Abdullah
🇲🇾Kuala Selangor, Malaysia
Internal Medicine and Critical Disease Research Unit
🇵🇪Arequipa, Peru
Institute of Gynecology and Reproduction
🇵🇪Lima, Peru
San Juan Bautista Clinic
🇵🇪Lima, Peru
Mary Mediatrix Medical Center
🇵🇭Lipa City, Batangas, Philippines
Iloilo Doctors' Hospital
🇵🇭Iloilo City, Iloilo, Philippines
ManilaMed - Medical Center Manila
🇵🇭Manila City, National Capital Region, Philippines
Chinese General Hospital
🇵🇭Manila City, 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
Braga Academic Clinical Center - Braga Hospital
🇵🇹Braga, Portugal
Western Lisbon Hospital Center, EPE - Santa Cruz Hospital
🇵🇹Carnaxide, Portugal
Lady of Oliveira Hospital - Guimarães, EPE
🇵🇹Guimarães, Portugal
Lisbon North Hospital and University Center (CHULN), E.P.E - Santa Maria Hospital
🇵🇹Lisboa, Portugal
Saint Anthony University Hospital Center
🇵🇹Porto, Portugal
Setúbal Hospital Center EPE
🇵🇹Setúbal, Portugal
GCM Medical Group
🇵🇷San Juan, Puerto Rico
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Belgrade, Serbia
University Clinical Center of Serbia
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Bellvitge University Hospital
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
University of Navarra Hospital
🇪🇸Pamplona, Navarra, Spain
Puigvert Foundation
🇪🇸Barcelona, Spain
Clinical Hospital of Barcelona
🇪🇸Barcelona, Spain
University Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Gregorio Marañón General University Hospital
🇪🇸Madrid, Spain
San Carlos Clinical Hospital
🇪🇸Madrid, Spain
University Hospital October 12
🇪🇸Madrid, Spain
Virgen del Rocío University Hospital
🇪🇸Sevilla, Spain
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan, Taiwan
Royal Derby Hospitals, University Hospitals of Derby and Burton
🇬🇧Derby, Derbyshire, United Kingdom
Salford Royal NHS Foundation Trust
🇬🇧Salford, Greater Manchester, United Kingdom
Churchill Hospital
🇬🇧Headington, Oxford, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, Tyne and Wear, United Kingdom
King's College Hospital
🇬🇧London, UK, United Kingdom
Leicester General Hospital
🇬🇧Leicester, United Kingdom
St. Georges University Hospitals
🇬🇧London, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
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