A Study of Zetomipzomib (KZR-616) in Patients with Active Lupus Nephritis (PALIZADE)

Last updated: November 15, 2024
Sponsor: Kezar Life Sciences, Inc.
Overall Status: Terminated

Phase

2

Condition

Kidney Disease

Lupus Nephritis

Nephritis

Treatment

zetomipzomib

placebo

Clinical Study ID

NCT05781750
KZR-616-202
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 antibodytest

  • Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renalbiopsy 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

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 52weeks prior to Screening

  • Thrombocytopenia or at high risk for developing clinically significant bleedingor organ dysfunction requiring therapies (i.e., plasmapheresis or acute bloodor platelet transfusions

  • Solid organ transplant or planned transplant during study

  • Malignancy of any type, with exceptions for non-melanoma skin cancers andcertain 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

Total Participants: 84
Treatment Group(s): 2
Primary Treatment: zetomipzomib
Phase: 2
Study Start date:
November 03, 2023
Estimated Completion Date:
November 08, 2024

Study 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.

Connect with a study center

  • The Medical Institute of the Clinical Studies Foundation

    Rosario, Santa Fe S2000DEJ
    Argentina

    Site Not Available

  • Mayo Clinic of UCMB SRL

    San Miguel De Tucumán, Tucumán T4000
    Argentina

    Site Not Available

  • Aprillus Assistance and Research by Arcis Health

    Buenos Aires, C1406AGA
    Argentina

    Site Not Available

  • Dr. Doreski Medical Offices

    Buenos Aires, C1426ABP
    Argentina

    Site Not Available

  • Framingham Medical Center

    Buenos Aires, B1902ADW
    Argentina

    Site Not Available

  • Medical Research Organization

    Buenos Aires, C1015
    Argentina

    Site Not Available

  • Military Central Hospital

    Buenos Aires, C1426BOS
    Argentina

    Site Not Available

  • Austral University Hospital

    Pilar, B1629ODT
    Argentina

    Site Not Available

  • Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • St George Hospital

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton Heights, New South Wales 2305
    Australia

    Site Not Available

  • Wollongong Hospital

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Gold Coast Hospital and Health Service

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Sunshine Hospital

    St Albans, Victoria 3021
    Australia

    Site Not Available

  • Senhor de Bonfim Clinic

    Salvador, Bahia 40415-065
    Brazil

    Site Not Available

  • Specialized Rheumatology Services of Bahia

    Salvador, Bahia 40150-150
    Brazil

    Site Not Available

  • L2IP - Clinical Research Institute

    Brasília, Distrito Federal 70200-730
    Brazil

    Site Not Available

  • Brasília Hospital

    Brasília, Federal District 71635-580
    Brazil

    Site Not Available

  • Hospital São Domingos

    São Luís, Maranhão 65060-645
    Brazil

    Site Not Available

  • Holy House of Mercy of Belo Horizonte

    Belo Horizonte, Minas Gerais 30150-221
    Brazil

    Site Not Available

  • Pro-Renal Institute Brazil

    Curitiba, Paraná 80440-020
    Brazil

    Site Not Available

  • LMK Medical Services SS

    Porto Alegre, Rio Grande do Sol 22061-080
    Brazil

    Site Not Available

  • Hospital Association Clinical Research Center - Windmills Hospital

    Porto Alegre, Rio Grande do Sul 90305-001
    Brazil

    Site Not Available

  • Pro-Rim Foundation Research Center

    Joinville, Santa Catarina 89227-680
    Brazil

    Site Not Available

  • Clinics Hospital FMRP

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Site Not Available

  • Praxis Medical Research

    Santo André, São Paulo 09090-790
    Brazil

    Site Not Available

  • Multidisciplinary Center for Clinical Studies

    São Bernardo Do Campo, São Paulo 09715-090
    Brazil

    Site Not Available

  • Faculty of Medicine of SJRP

    São José Do Rio Preto, São Paulo 15090-000
    Brazil

    Site Not Available

  • Hospital São Lucas Copacabana

    Rio De Janeiro, 22061-080
    Brazil

    Site Not Available

  • Clinical Hospital FMUSP

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Hospital Nove de Julho

    São Paulo, 01409-902
    Brazil

    Site Not Available

  • Oswaldo Ramos Foundation

    São Paulo, 04038-002
    Brazil

    Site Not Available

  • Saint Marcelina Hospital

    São Paulo, 08270-070
    Brazil

    Site Not Available

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

  • The Fifth Hospital of Xiamen

    Xiamen, Fujian 361101
    China

    Site Not Available

  • The First People's Hospital of Foshan

    Foshan, Guangdong 528000
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong 528401
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473005
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 226001
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221002
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin 130033
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong 317000
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Huangpu, Shanghai 200003
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • Mianyang Central Hospital

    Mianyang, Sichuan 621000
    China

    Site Not Available

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan 637001
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 311121
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang 317000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Alma Mater Hospital of Antioquia

    Medellín, Antioquia 050010
    Colombia

    Site Not Available

  • Costa Clinica

    Barranquilla, Atlántico 080020
    Colombia

    Site Not Available

  • Healthy Medical Center S.A.S.

    Zipaquirá, Cundinamarca 250252
    Colombia

    Site Not Available

  • Cardiovascular Foundation of Colombia

    Bucaramanga, Santander 681017
    Colombia

    Site Not Available

  • IPS Julian Coronel Medical Center SAS

    Cali, Valle de Cauca 760035
    Colombia

    Site Not Available

  • University Hospital of Split

    Split, 21000
    Croatia

    Site Not Available

  • Solmed Clinic

    Zagreb, 10000
    Croatia

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  • University Hospital Center Zagreb

    Zagreb, 10000
    Croatia

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  • Laiko General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • University General Hospital of Larisa

    Larisa, 41110
    Greece

    Site Not Available

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki, 54642
    Greece

    Site Not Available

  • Center for Advanced Health Clinical Studies

    Guatemala, 01009
    Guatemala

    Site Not Available

  • Clinical Research Center, S.A.

    Guatemala, 01010
    Guatemala

    Site Not Available

  • Medical Clinic Specialized in Nephrology

    Guatemala, 01010
    Guatemala

    Site Not Available

  • Medical Clinic Specialized in Internal Medicine and Rheumatology

    Guatemala City, 01011
    Guatemala

    Site Not Available

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh 492099
    India

    Site Not Available

  • Nirmal Hospital

    Surat, Guajrat 395002
    India

    Site Not Available

  • Unity Hospital

    Surat, Guajrat 395010
    India

    Site Not Available

  • Panchshil Hospital

    Ahmedabad, Gujarat 380005
    India

    Site Not Available

  • KLES Dr Prabhakar Kore Hospital and Medical Research Centre

    Belgaum, Karnataka 590010
    India

    Site Not Available

  • Elite Mission Hospital

    Thrissur, Kerala 680007
    India

    Site Not Available

  • MGM Medical College and Hospital

    Aurangabad, Maharashtra 431003
    India

    Site Not Available

  • Jasleen Hospital

    Nagpur, Maharashtra 440012
    India

    Site Not Available

  • Kingsway Hospital

    Nagpur, Maharashtra 440001
    India

    Site Not Available

  • Assured Care Plus Hospital

    Nashik, Maharashtra 422101
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi, NCT of Delhi 110060
    India

    Site Not Available

  • SMS Medical College

    Jaipur, Rajasthan 302001
    India

    Site Not Available

  • Christian Medical College

    Ranipet, Tamil Nadu 632517
    India

    Site Not Available

  • Yashoda Hospitals

    Hyderabad, Telangana India
    India

    Site Not Available

  • Krishna Institute of Medical Science

    Secunderabad, Telangana 500003
    India

    Site Not Available

  • Fortis Hospital

    Kolkata, West Bengal 700107
    India

    Site Not Available

  • Institute of Post Graduate Medical Education and Research / SSKM Hospital

    Kolkata, West Bengal 700020
    India

    Site Not Available

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, 13496
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Seoul

    Seoul, 04401
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang 25100
    Malaysia

    Site Not Available

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak 30450
    Malaysia

    Site Not Available

  • Hospital Selayang

    Batu Caves, Selangor 68100
    Malaysia

    Site Not Available

  • Hospital Sultan Idris Shah Serdang

    Kajang, Selangor 43000
    Malaysia

    Site Not Available

  • Hospital Canselor Tuanku Muhriz UKM

    Kuala Lumpur, Wilayah Persekutuan 56000
    Malaysia

    Site Not Available

  • Prince Court Medical Centre

    Kuala Lumpur, Wilayah Persekutuan 50450
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Hospital Al Sultan Abdullah

    Kuala Selangor, 43200
    Malaysia

    Site Not Available

  • Internal Medicine and Critical Disease Research Unit

    Arequipa, 04000
    Peru

    Site Not Available

  • Institute of Gynecology and Reproduction

    Lima, 15023
    Peru

    Site Not Available

  • San Juan Bautista Clinic

    Lima, 15431
    Peru

    Site Not Available

  • Mary Mediatrix Medical Center

    Lipa City, Batangas 4217
    Philippines

    Site Not Available

  • Iloilo Doctors' Hospital

    Iloilo City, Iloilo 5000
    Philippines

    Site Not Available

  • Chinese General Hospital

    Manila City, National Capital Region 1014
    Philippines

    Site Not Available

  • ManilaMed - Medical Center Manila

    Manila City, National Capital Region 1000
    Philippines

    Site Not Available

  • Far Eastern University Hospital Nicanor Reyes Medical Foundation

    Quezon City, National Capital Region 1118
    Philippines

    Site Not Available

  • St. Luke's Medical Center

    Quezon City, National Capital Region 1102
    Philippines

    Site Not Available

  • University of Santo Tomas Hospital

    Manila, 1015
    Philippines

    Site Not Available

  • Braga Academic Clinical Center - Braga Hospital

    Braga, 4710-243
    Portugal

    Site Not Available

  • Western Lisbon Hospital Center, EPE - Santa Cruz Hospital

    Carnaxide, 2790-134
    Portugal

    Site Not Available

  • Lady of Oliveira Hospital - Guimarães, EPE

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • Lisbon North Hospital and University Center (CHULN), E.P.E - Santa Maria Hospital

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Saint Anthony University Hospital Center

    Porto, 4050-011
    Portugal

    Site Not Available

  • Setúbal Hospital Center EPE

    Setúbal, 2910-446
    Portugal

    Site Not Available

  • GCM Medical Group

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000
    Serbia

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Clinical Center of Serbia

    Belgrade, 11000
    Serbia

    Site Not Available

  • University Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • General Hospital Krusevac

    Krusevac, 37000
    Serbia

    Site Not Available

  • University Clinical Center Niš

    Niš, 18000
    Serbia

    Site Not Available

  • National University Hospital

    Singapore, 119228
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Phoenix Pharma

    Port Elizabeth, Eastern Cape 6001
    South Africa

    Site Not Available

  • CRISMO Research Centre

    Germiston, Gauteng 1401
    South Africa

    Site Not Available

  • Arthritis Clinical Trial Centre

    Cape Town, Western Cape 7405
    South Africa

    Site Not Available

  • Bellvitge University Hospital

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • University of Navarra Hospital

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Clinical Hospital of Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Puigvert Foundation

    Barcelona, 08025
    Spain

    Site Not Available

  • University Hospital Arnau de Vilanova

    Lleida, 25198
    Spain

    Site Not Available

  • Gregorio Marañón General University Hospital

    Madrid, 28007
    Spain

    Site Not Available

  • San Carlos Clinical Hospital

    Madrid, 28040
    Spain

    Site Not Available

  • University Hospital October 12

    Madrid, 28041
    Spain

    Site Not Available

  • Virgen del Rocío University Hospital

    Sevilla, 41013
    Spain

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 833401
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Keelung, 204
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Keelung City, 204
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei, 220
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Royal Derby Hospitals, University Hospitals of Derby and Burton

    Derby, Derbyshire DE22 3NE
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester M6 8HD
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Headington, Oxford OX3 7LJ
    United Kingdom

    Site Not Available

  • Sunderland Royal Hospital

    Sunderland, Tyne and Wear SR4 7TP
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, UK SE5 9RS
    United Kingdom

    Site Not Available

  • Leicester General Hospital

    Leicester, LE5 4PW
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, W12 0HS
    United Kingdom

    Site Not Available

  • St. Georges University Hospitals

    London, SW17 0QT
    United Kingdom

    Site Not Available

  • Nephrology Consultants, LLC

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Southwest Kidney Institute

    Surprise, Arizona 85374
    United States

    Site Not Available

  • Valerius Medical Group and Research Center of Greater Long Beach, Inc.

    Los Alamitos, California 90720
    United States

    Site Not Available

  • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

    Torrance, California 90502
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Phoenix Research Center, LLC

    Miami, Florida 33186
    United States

    Site Not Available

  • Reliant Medical Research

    Miami, Florida 33165
    United States

    Site Not Available

  • Elixia Central Florida

    Orlando, Florida 32806
    United States

    Site Not Available

  • West Broward Rheumatology Associates, Inc.

    Tamarac, Florida 33321
    United States

    Site Not Available

  • ClinCept Clinical Research

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Southeast Kidney Associates

    East Point, Georgia 30344
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Accurate Clinical Research - Lake Charles

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43201
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Clinical Renal Associates

    Langhorne, Pennsylvania 19047
    United States

    Site Not Available

  • Clinical Renal Associates, Ltd.

    Upland, Pennsylvania 19013
    United States

    Site Not Available

  • Nephrology Associates, Inc

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Hypertension and Nephrology Inc

    Providence, Rhode Island 02904
    United States

    Site Not Available

  • Texas Tech University Health Science Center

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas 76034
    United States

    Site Not Available

  • Texas Kidney Institute

    Dallas, Texas 75231
    United States

    Site Not Available

  • Prolato Clinical Research Center (PCRC)

    Houston, Texas 77054
    United States

    Site Not Available

  • North Texas Kidney Disease Associates

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Renal Specialists of Houston

    Pasadena, Texas 77504
    United States

    Site Not Available

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