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

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 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).

Study Overview

• Status: Recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: zetomipzomib; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 279
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kezar Life Sciences, Inc; Phone Number: (650) 640-4480; Email: PALIZADE@kezarbio.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Recruiting
    • Dr. Doreski Medical Offices
    • Contact: Dr. Alejandro Arroyo
    • Principal Investigator: Dr. Alejandro Arroyo
  • Buenos Aires, Argentina, C1406AGA
    • Recruiting
    • Aprillus Assistance and Research by Arcis Health
    • Contact: Dr. Pablo Mannucci
    • Principal Investigator: Dr. Pablo Mannucci
  • Buenos Aires, Argentina, B1902ADW
    • Recruiting
    • Framingham Medical Center
    • Contact: Dr. Jesús Abel Cuadrado
    • Principal Investigator: Dr. Jesús Abel Cuadrado
  • Buenos Aires, Argentina, C1015
    • Recruiting
    • Medical Research Organization
    • Contact: Dr. Ana Valeria Malvar Perrin
    • Principal Investigator: Dr. Ana Valeria Malvar Perrin
  • Buenos Aires, Argentina, C1426BOS
    • Recruiting
    • Military Central Hospital
    • Contact: Dr. Gustavo Casado
    • Principal Investigator: Dr. Gustavo Casado
  • Pilar, Argentina, B1629ODT
    • Recruiting
    • Austral University Hospital
    • Contact: Dr. Pablo Jorge Maid
    • Principal Investigator: Dr. Pablo Jorge Maid
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DEJ
      • Recruiting
      • The Medical Institute of the Clinical Studies Foundation
      • Contact: Dr. Juan Oddino
      • Principal Investigator: Dr. Juan Oddino
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000
      • Recruiting
      • Mayo Clinic of UCMB SRL
      • Contact: Dr. Francisco Colombres
      • Principal Investigator: Dr. Francisco Colombres
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Recruiting
      • Canberra Hospital
      • Contact: Dr. Walter Giles
      • Principal Investigator: Dr. Walter Giles
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • Recruiting
      • St George Hospital
      • Contact: Dr. Sunil Badve
      • Principal Investigator: Dr. Sunil Badve
    • New Lambton Heights, New South Wales, Australia, 2305
      • Recruiting
      • John Hunter Hospital
      • Contact: Dr. Bruce MacKinnon
      • Principal Investigator: Dr. Bruce MacKinnon
    • Wollongong, New South Wales, Australia, 2500
      • Recruiting
      • Wollongong Hospital
      • Contact: Dr. Karumathil Murali
      • Principal Investigator: Dr. Karumathil Murali
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Recruiting
      • Gold Coast Hospital and Health Service
      • Contact: Dr. Jagadeesh Kurtkoti
      • Principal Investigator: Dr. Jagadeesh Kurtkoti
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health
      • Contact: Dr. Joanna Kent
      • Principal Investigator: Dr. Joanna Kent
    • Parkville, Victoria, Australia, 3050
      • Recruiting
      • Royal Melbourne Hospital
      • Contact: Dr. Irene Ruderman
      • Principal Investigator: Dr. Irene Ruderman
    • St Albans, Victoria, Australia, 3021
      • Recruiting
      • Sunshine Hospital
      • Contact: Dr. Andrew Talbot
      • Principal Investigator: Dr. Andrew Talbot
• Brazil
  • Rio De Janeiro, Brazil, 22061-080
    • Recruiting
    • Hospital São Lucas Copacabana
    • Contact: Dr. Paula Paiva
    • Principal Investigator: Dr. Paula Paiva
  • São Paulo, Brazil, 01409-902
    • Recruiting
    • Hospital Nove de Julho
    • Contact: Dr. Maria Júlia Araújo
    • Principal Investigator: Dr. Maria Júlia Araújo
  • São Paulo, Brazil, 08270-070
    • Recruiting
    • Saint Marcelina Hospital
    • Contact: Dr. Marcella LaFerreira
    • Principal Investigator: Dr. Marcella LaFerreira
  • São Paulo, Brazil, 05403-000
    • Recruiting
    • Clinical Hospital FMUSP
    • Contact: Dr. Irene de Lourdes Noronha
    • Principal Investigator: Dr. Irene de Lourdes Noronha
  • São Paulo, Brazil, 04038-002
    • Recruiting
    • Oswaldo Ramos Foundation
    • Contact: Dr. Juliana Mansur Siliano
    • Principal Investigator: Dr. Juliana Mansur Siliano
  • Bahia
    • Salvador, Bahia, Brazil, 40150-150
      • Recruiting
      • Specialized Rheumatology Services of Bahia
      • Contact: Dr. Mittermayer Barreto Santiago
      • Principal Investigator: Dr. Mittermayer Barreto Santiago
    • Salvador, Bahia, Brazil, 40415-065
      • Recruiting
      • Senhor de Bonfim Clinic
      • Contact: Dr. Raphael Paschoalin
      • Principal Investigator: Dr. Raphael Paschoalin
  • Distrito Federal
    • Brasília, Distrito Federal, Brazil, 70200-730
      • Recruiting
      • L2IP - Clinical Research Institute
      • Contact: Dr. Eduardo Vasconcellos
      • Principal Investigator: Dr. Eduardo Vasconcellos
  • Federal District
    • Brasília, Federal District, Brazil, 71635-580
      • Recruiting
      • Brasília Hospital
      • Contact: Dr. Tainá Carneiro
      • Principal Investigator: Dr. Tainá Carneiro
  • Maranhão
    • São Luís, Maranhão, Brazil, 65060-645
      • Recruiting
      • Hospital São Domingos
      • Contact: Dr. Thayse Mayara Aragão Siqueira
      • Principal Investigator: Dr. Thayse Mayara Aragão Siqueira
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Recruiting
      • Holy House of Mercy of Belo Horizonte
      • Contact: Dr. Pedro Augusto Macedo de Souza
      • Principal Investigator: Dr. Pedro Augusto Macedo de Souza
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-020
      • Recruiting
      • Pro-Renal Institute Brazil
      • Contact: Dr. Miguel Riella
      • Principal Investigator: Dr. Miguel Riella
  • Rio Grande Do Sol
    • Porto Alegre, Rio Grande Do Sol, Brazil, 22061-080
      • Recruiting
      • LMK Medical Services SS
      • Contact: Dr. Mauro Keiserman
      • Principal Investigator: Dr. Mauro Keiserman
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90305-001
      • Recruiting
      • Hospital Association Clinical Research Center - Windmills Hospital
      • Contact: Dr. Cecília Varella da Costa
      • Principal Investigator: Dr. Cecília Varella da Costa
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89227-680
      • Recruiting
      • Pro-Rim Foundation Research Center
      • Contact: Dr. Luciane Deboni
      • Principal Investigator: Dr. Luciane Deboni
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Recruiting
      • Clinics Hospital FMRP
      • Contact: Dr. Rodrigo de Oliveira
      • Principal Investigator: Dr. Rodrigo de Oliveira
    • Santo André, São Paulo, Brazil, 09090-790
      • Recruiting
      • Praxis Medical Research
      • Contact: Dr. Marcelo Bacci
      • Principal Investigator: Dr. Marcelo Bacci
    • São Bernardo Do Campo, São Paulo, Brazil, 09715-090
      • Recruiting
      • Multidisciplinary Center for Clinical Studies
      • Contact: Dr. Daniel Rinaldi dos Santos
      • Principal Investigator: Dr. Daniel Rinaldi dos Santos
    • São José Do Rio Preto, São Paulo, Brazil, 15090-000
      • Recruiting
      • Faculty of Medicine of SJRP
      • Contact: Dr. Mariana Alves Martins Ferreira
      • Principal Investigator: Dr. Mariana Alves Martins Ferreira
• Croatia
  • Split, Croatia, 21000
    • Recruiting
    • University Hospital of Split
    • Contact: Dr. Dijana Perković
    • Principal Investigator: Dr. Dijana Perković
  • Zagreb, Croatia, 10000
    • Recruiting
    • University Hospital Center Zagreb
    • Contact: Dr. Ivana Vuković Brinar
    • Principal Investigator: Dr. Ivana Vuković Brinar
  • Zagreb, Croatia, 10000
    • Recruiting
    • Solmed Clinic
    • Contact: Dr. Ingrid Prkacin
    • Principal Investigator: Dr. Ingrid Prkacin
• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Laiko General Hospital of Athens
    • Contact: Dr. Smargdi Marinaki
    • Principal Investigator: Dr. Smargdi Marinaki
  • Larisa, Greece, 41110
    • Recruiting
    • University General Hospital of Larisa
    • Contact: Dr. Christina Katsiari
    • Principal Investigator: Dr. Christina Katsiari
  • Thessaloniki, Greece, 54642
    • Recruiting
    • Ippokratio General Hospital of Thessaloniki
    • Contact: Dr. Maria Stangou
    • Principal Investigator: Dr. Maria Stangou
• Guatemala
  • Guatemala, Guatemala, 01010
    • Recruiting
    • Clinical Research Center, S.A.
    • Contact: Dr. Alejandro Jovel
    • Principal Investigator: Dr. Alejandro Jovel
  • Guatemala, Guatemala, 01010
    • Recruiting
    • Medical Clinic Specialized in Nephrology
    • Contact: Dr. Jose Sanchez
    • Principal Investigator: Dr. Jose Sanchez
  • Guatemala, Guatemala, 01009
    • Recruiting
    • Center for Advanced Health Clinical Studies
    • Contact: Dr. Miriam Carrascosca
    • Principal Investigator: Dr. Miriam Carrascosca
  • Guatemala City, Guatemala, 01010
    • Recruiting
    • Medical Clinic Specialized in Internal Medicine and Rheumatology
    • Contact: Dr. Nilmo Chávez
    • Principal Investigator: Dr. Nilmo Chávez
  • Guatemala City, Guatemala, 01011
    • Recruiting
    • Medical Clinic Specialized in Internal Medicine and Rheumatology
    • Contact: Dr. Maynor Herrera
    • Principal Investigator: Dr. Maynor Herrera
• India
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 492099
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Dr. Vinay Rathore
      • Principal Investigator: Dr. Vinay Rathore
  • Guajrat
    • Surat, Guajrat, India, 395002
      • Recruiting
      • Nirmal Hospital
      • Contact: Dr. Bankimchandra Desai
      • Principal Investigator: Dr. Bankimchandra Desai
    • Surat, Guajrat, India, 395010
      • Recruiting
      • Unity Hospital
      • Contact: Dr. Siddharth Jain
      • Principal Investigator: Dr. Siddharth Jain
  • Gujarat
    • Ahmedabad, Gujarat, India, 380005
      • Recruiting
      • Panchshil Hospital
      • Contact: Dr. Vishnu Sharma
      • Principal Investigator: Dr. Vishnu Sharma
  • Karnataka
    • Belgaum, Karnataka, India, 590010
      • Recruiting
      • KLES Dr Prabhakar Kore Hospital and Medical Research Centre
      • Contact: Dr. Ritesh Vernekar
      • Principal Investigator: Dr. Ritesh Vernekar
  • Kerala
    • Thrissur, Kerala, India, 680007
      • Recruiting
      • Elite Mission Hospital
      • Contact: Dr. Vinod Baburajan
      • Principal Investigator: Dr. Vinod Baburajan
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431003
      • Recruiting
      • MGM Medical College and Hospital
      • Contact: Dr. Sudhir Gajanan Kulkarni
      • Principal Investigator: Dr. Sudhir Gajanan Kulkarni
    • Nagpur, Maharashtra, India, 440001
      • Recruiting
      • Kingsway Hospital
      • Contact: Dr. Prakash Pralhad Khetan
      • Principal Investigator: Dr. Prakash Pralhad Khetan
    • Nagpur, Maharashtra, India, 440012
      • Recruiting
      • Jasleen Hospital
      • Contact: Dr. Smruti Ramteke
      • Principal Investigator: Dr. Smruti Ramteke
    • Nashik, Maharashtra, India, 422101
      • Recruiting
      • Assured Care Plus Hospital
      • Contact: Dr. Praveen Jadhav
      • Principal Investigator: Dr. Praveen Jadhav
  • NCT Of Delhi
    • New Delhi, NCT Of Delhi, India, 110060
      • Recruiting
      • Sir Ganga Ram Hospital
      • Contact: Dr. Anurag Gupta
      • Principal Investigator: Dr. Anurag Gupta
  • Rajasthan
    • Jaipur, Rajasthan, India, 302001
      • Recruiting
      • SMS Medical College
      • Contact: Dr. Dhananjai Agrawal
      • Principal Investigator: Dr. Dhananjai Agrawal
  • Telangana
    • Hyderabad, Telangana, India, India
      • Recruiting
      • Yashoda Hospitals
      • Contact: Dr. Rajasekara Chakravarthi
      • Principal Investigator: Dr. Rajasekara Chakravarthi
    • Secunderabad, Telangana, India, 500003
      • Recruiting
      • Krishna Institute of Medical Science
      • Contact: Dr. Sarath Veeravalli
      • Principal Investigator: Dr. Sarath Veeravalli
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13496
    • Recruiting
    • CHA Bundang Medical Center, CHA University
    • Contact: Dr. Hyung Jong Kim
    • Principal Investigator: Dr. Hyung Jong Kim
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Dr. Sehoon Park
    • Principal Investigator: Dr. Sehoon Park
  • Seoul, Korea, Republic of, 06591
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Contact: Dr. Sung-Hwan Park
    • Principal Investigator: Dr. Sung-Hwan Park
  • Seoul, Korea, Republic of, 04401
    • Recruiting
    • Soon Chun Hyang University Hospital Seoul
    • Contact: Dr. Jin Seok Jeon
    • Principal Investigator: Dr. Jin Seok Jeon
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Centre
    • Contact: Dr. Ng Kok Peng
    • Principal Investigator: Dr. Ng Kok Peng
  • Kuala Selangor, Malaysia, 43200
    • Recruiting
    • Hospital Al Sultan Abdullah
    • Contact: Dr. Muhammad Iqbal Adbul Hafidz
    • Principal Investigator: Dr. Muhammad Iqbal Adbul Hafidz
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Recruiting
      • Hospital Tengku Ampuan Afzan
      • Contact: Dr. Fariz Safhan Mohamad Nor
      • Principal Investigator: Dr. Fariz Safhan Mohamad Nor
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Recruiting
      • Hospital Raja Permaisuri Bainun
      • Contact: Dr. Chek Loong Loh
      • Principal Investigator: Dr. Chek Loong Loh
  • Selangor
    • Batu Caves, Selangor, Malaysia, 68100
      • Recruiting
      • Hospital Selayang
      • Contact: Dr. Suryati Yakob
      • Principal Investigator: Dr. Suryati Yakob
    • Kajang, Selangor, Malaysia, 43000
      • Recruiting
      • Hospital Sultan Idris Shah Serdang
      • Contact: Dr. Fairol Huda Ibrahim
      • Principal Investigator: Dr. Fairol Huda Ibrahim
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50450
      • Recruiting
      • Prince Court Medical Centre
      • Contact: Dr. Mohamad Zaimi Abdul Wahab
      • Principal Investigator: Dr. Mohamad Zaimi Abdul Wahab
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
      • Recruiting
      • Hospital Canselor Tuanku Muhriz UKM
      • Contact: Dr. Abdul Halim Abdul Gafor
      • Principal Investigator: Dr. Abdul Halim Abdul Gafor
• Philippines
  • Manila, Philippines, 1015
    • Recruiting
    • University of Santo Tomas Hospital
    • Contact: Dr. Sandra Navarra
    • Principal Investigator: Dr. Sandra Navarra
  • Batangas
    • Lipa City, Batangas, Philippines, 4217
      • Recruiting
      • Mary Mediatrix Medical Center
      • Contact: Dr. Allan Lanzon
      • Principal Investigator: Dr. Allan Lanzon
  • Iloilo
    • Iloilo City, Iloilo, Philippines, 5000
      • Recruiting
      • Iloilo Doctors' Hospital
      • Contact: Dr. Caroline Arroyo
      • Principal Investigator: Dr. Caroline Arroyo
  • National Capital Region
    • Manila City, National Capital Region, Philippines, 1000
      • Recruiting
      • ManilaMed - Medical Center Manila
      • Contact: Dr. Michael Tee
      • Principal Investigator: Dr. Michael Tee
    • Manila City, National Capital Region, Philippines, 1014
      • Recruiting
      • Chinese General Hospital
      • Contact: Dr. Julie Li-Yu
      • Principal Investigator: Dr. Julie Li-Yu
    • Quezon City, National Capital Region, Philippines, 1102
      • Recruiting
      • St. Luke's Medical Center
      • Contact: Dr. Melissa Aquino-Villamin
      • Principal Investigator: Dr. Melissa Aquino-Villamin
    • Quezon City, National Capital Region, Philippines, 1118
      • Recruiting
      • Far Eastern University Hospital Nicanor Reyes Medical Foundation
      • Contact: Dr. Rosario Baes
      • Principal Investigator: Dr. Rosario Baes
• Portugal
  • Braga, Portugal, 4710-243
    • Recruiting
    • Braga Academic Clinical Center - Braga Hospital
    • Contact: Dr. Joana Silva
    • Principal Investigator: Dr. Joana Silva
  • Carnaxide, Portugal, 2790-134
    • Recruiting
    • Western Lisbon Hospital Center, EPE - Santa Cruz Hospital
    • Contact: Dr. Ivo Laranjinha
    • Principal Investigator: Dr. Ivo Laranjinha
  • Guimarães, Portugal, 4835-044
    • Recruiting
    • Lady of Oliveira Hospital - Guimarães, EPE
    • Contact: Dr. Sara Freitas
    • Principal Investigator: Dr. Sara Freitas
  • Lisboa, Portugal, 1649-035
    • Recruiting
    • Lisbon North Hospital and University Center (CHULN), E.P.E - Santa Maria Hospital
    • Contact: Dr. Iolanda Godinho
    • Principal Investigator: Dr. Iolanda Godinho
  • Porto, Portugal, 4050-011
    • Recruiting
    • Saint Anthony University Hospital Center
    • Contact: Dr. António Marinho
    • Principal Investigator: Dr. António Marinho
  • Setúbal, Portugal, 2910-446
    • Recruiting
    • Setúbal Hospital Center EPE
    • Contact: Dr. Elsa Soares
    • Principal Investigator: Dr. Elsa Soares
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Recruiting
    • GCM Medical Group
    • Contact: Karina Vila-Rivera, MD
    • Principal Investigator: Karina Vila-Rivera, MD
• Singapore
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Dr. See Cheng Yeo
    • Principal Investigator: Dr. See Cheng Yeo
  • Singapore, Singapore, 119228
    • Recruiting
    • National University Hospital
    • Contact: Dr. Boon Wee Teo
    • Principal Investigator: Dr. Boon Wee Teo
• South Africa
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6001
      • Recruiting
      • Phoenix Pharma
      • Contact: Dr. Daniel Malan
      • Principal Investigator: Dr. Daniel Malan
  • Gauteng
    • Germiston, Gauteng, South Africa, 1401
      • Recruiting
      • CRISMO Research Centre
      • Contact: Dr. Wesley Tulleken
      • Principal Investigator: Dr. Wesley Tulleken
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7405
      • Recruiting
      • Arthritis Clinical Trial Centre
      • Contact: Dr. Rehana Bhorat
      • Principal Investigator: Dr. Rehana Bhorat
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Clinical Hospital of Barcelona
    • Contact: Dr. Luis Quintana Porras
    • Principal Investigator: Dr. Luis Quintana Porras
  • Barcelona, Spain, 08025
    • Recruiting
    • Puigvert Foundation
    • Contact: Dr. Montserrat Díaz Encarnación
    • Principal Investigator: Dr. Montserrat Díaz Encarnación
  • Lleida, Spain, 25198
    • Recruiting
    • University Hospital Arnau de Vilanova
    • Contact: Dr. María Luisa Martin Conde
    • Principal Investigator: Dr. María Luisa Martin Conde
  • Madrid, Spain, 28040
    • Recruiting
    • San Carlos Clinical Hospital
    • Contact: Dr. Clara García Carro
    • Principal Investigator: Dr. Clara García Carro
  • Madrid, Spain, 28041
    • Recruiting
    • University Hospital October 12
    • Contact: Dr. Enrique Morales Ruíz
    • Principal Investigator: Dr. Enrique Morales Ruíz
  • Madrid, Spain, 28007
    • Recruiting
    • Gregorio Marañón General University Hospital
    • Contact: Dr. Jose Maria Alvaro-Gracia
    • Principal Investigator: Dr. Jose Maria Alvaro-Gracia
  • Sevilla, Spain, 41013
    • Recruiting
    • Virgen del Rocío University Hospital
    • Contact: Dr. Manuel Lopez Mendoza
    • Principal Investigator: Dr. Manuel Lopez Mendoza
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Bellvitge University Hospital
      • Contact: Dr. Xavier Fulladosa
      • Principal Investigator: Dr. Xaiver Fulladosa
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • University of Navarra Hospital
      • Contact: Dr. Patricia Fanlo Mateo
      • Principal Investigator: Dr. Patricia Fanlo Mateo
• Taiwan
  • Kaohsiung, Taiwan, 81362
    • Recruiting
    • Kaohsiung Veterans General Hospital
    • Contact: Dr. Jui-Cheng Tseng
    • Principal Investigator: Dr. Jui-Cheng Tseng
  • Kaohsiung, Taiwan, 833401
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Dr. Jin-Bor Chen
    • Principal Investigator: Dr. Jin-Bor Chen
  • Keelung, Taiwan, 204
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Dr. Chin-Chan Lee
    • Principal Investigator: Dr. Chin-Chan Lee
  • New Taipei, Taiwan, 220
    • Recruiting
    • Far Eastern Memorial Hospital
    • Contact: Dr. Yu-Sen Peng
    • Principal Investigator: Dr. Yu-Sen Peng
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
    • Contact: Dr. Joung-Liang Lan
    • Principal Investigator: Dr. Joung-Liang Lan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital, Linkou
    • Contact: Dr. Yao-Fan Fang
    • Principal Investigator: Dr. Yao-Fan Fang
• United Kingdom
  • Leicester, United Kingdom, LE5 4PW
    • Recruiting
    • Leicester General Hospital
    • Contact: Dr. Chee Kay Cheung
    • Principal Investigator: Dr. Chee Kay Cheung
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Hammersmith Hospital
    • Contact: Dr. Elizabeth Lightstone
    • Principal Investigator: Dr. Elizabeth Lightstone
  • London, United Kingdom, SW17 0QT
    • Recruiting
    • St. Georges University Hospitals
    • Contact: Dr. Richard Hull
    • Principal Investigator: Dr. Richard Hull
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Recruiting
      • Royal Derby Hospitals, University Hospitals of Derby and Burton
      • Contact: Dr. Zoe Pittman
      • Principal Investigator: Dr. Zoe Pittman
  • Greater Manchester
    • Salford, Greater Manchester, United Kingdom, M6 8HD
      • Recruiting
      • Salford Royal NHS Foundation Trust
      • Contact: Dr. Edmond O'Riordan
      • Principal Investigator: Dr. Edmond O'Riordan
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LJ
      • Recruiting
      • Churchill Hospital
      • Contact: Dr. Edward Sharples
      • Principal Investigator: Dr. Edward Sharples
  • Tyne And Wear
    • Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
      • Recruiting
      • Sunderland Royal Hospital
      • Contact: Dr. Samuel Duffy
      • Principal Investigator: Dr. Samuel Duffy
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Recruiting
      • Nephrology Consultants, LLC
      • Principal Investigator: David Tietjen, MD
      • Contact: David Tietjen, MD
  • Arizona
    • Surprise, Arizona, United States, 85374
      • Recruiting
      • Southwest Kidney Institute
      • Contact: Minesh Rajpal, MD
      • Principal Investigator: Minesh Rajpal, MD
  • California
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Valerius Medical Group and Research Center of Greater Long Beach, Inc.
      • Principal Investigator: Nathaniel Neal, MD
      • Contact: Nathaniel Neal, MD
    • Torrance, California, United States, 90502
      • Recruiting
      • The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center
      • Contact: George Karpouzas, MD
      • Principal Investigator: George Karpouzas, MD
  • Florida
    • Miami, Florida, United States, 33165
      • Recruiting
      • Reliant Medical Research
      • Contact: Ramses Vega, MD
      • Principal Investigator: Ramses Vega, MD
    • Miami, Florida, United States, 33186
      • Recruiting
      • Phoenix Research Center, LLC
      • Principal Investigator: Amarilis Gonzalez, MD
      • Contact: Amarilis Gonzalez, MD
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Elixia Central Florida
      • Contact: Arvind Madan, MD
      • Principal Investigator: Arvin Madan, MD
    • Tamarac, Florida, United States, 33321
      • Recruiting
      • West Broward Rheumatology Associates, Inc.
      • Principal Investigator: Steven Kimmel, MD
      • Contact: Steven Kimmel, MD
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • ClinCept Clinical Research
      • Contact: Fahd Syed, MD
      • Principal Investigator: Fahd Syed, MD
    • East Point, Georgia, United States, 30344
      • Recruiting
      • Southeast Kidney Associates
      • Contact: Khalid Iqbal, MD
      • Principal Investigator: Khalid Iqbal, MD
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Shikha Wadhwani, MD
      • Principal Investigator: Shikha Wadhwani, MD
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Recruiting
      • Accurate Clinical Research - Lake Charles
      • Principal Investigator: Enrique Mendez, MD
      • Contact: Enrique Mendez, MD
  • New York
    • Great Neck, New York, United States, 11021
      • Recruiting
      • Northwell Health
      • Contact: Richard Furie, MD
      • Principal Investigator: Richard Furie, MD
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Amit Saxena, MD
      • Contact: Amit Saxena, MD
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Samir Parikh, MD
      • Principal Investigator: Samir Parikh, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Oklahoma Medical Research Foundation
      • Contact: Cristina Arriens, MD, MSCS
      • Principal Investigator: Cristina Arriens, MD, MSCS
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Recruiting
      • Clinical Renal Associates
      • Contact: Gary Sirken, DO
      • Principal Investigator: Gary Sirken, DO
    • Upland, Pennsylvania, United States, 19013
      • Recruiting
      • Clinical Renal Associates, Ltd.
      • Contact: Heather Mascio, DO
      • Principal Investigator: Heather Mascio, DO
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Recruiting
      • Nephrology Associates, Inc
      • Contact: Larissa Kruger Gomes, MD
      • Principal Investigator: Larissa Kruger Gomes, MD
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • Hypertension and Nephrology Inc
      • Contact: Keith Bartolomei, MD
      • Principal Investigator: Keith Bartolomei, MD
  • Texas
    • Colleyville, Texas, United States, 76034
      • Recruiting
      • Precision Comprehensive Clinical Research Solutions
      • Principal Investigator: Dhiman Basu, MD
      • Contact: Dhiman Basu, MD
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Texas Kidney Institute
      • Principal Investigator: Sumit Kumar, MD
      • Contact: Sumit Kumar, MD
    • Houston, Texas, United States, 77054
      • Recruiting
      • Prolato Clinical Research Center (PCRC)
      • Principal Investigator: Biruh Workeneh, MD
      • Contact: Biruh Workeneh, MD
    • Lewisville, Texas, United States, 75057
      • Recruiting
      • North Texas Kidney Disease Associates
      • Contact: Bruce Baker, MD
      • Principal Investigator: Bruce Baker, MD
    • Pasadena, Texas, United States, 77504
      • Recruiting
      • Renal Specialists of Houston
      • Contact: June Yao, MD
      • Principal Investigator: June Yao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zetomipzomib 30 mg + standard-of-care; Initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through 52 weeks of the treatment period.	Drug: zetomipzomib; Subcutaneous injection of zetomipzomib; Other Names: KZR-616
Experimental: zetomipzomib 60 mg + standard-of-care; Initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through 52 weeks of the treatment period.	Drug: zetomipzomib; Subcutaneous injection of zetomipzomib; Other Names: KZR-616
Placebo Comparator: placebo + standard-of-care; Initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through 52 weeks of the treatment period.	Drug: placebo; Subcutaneous injection of placebo; Other Names: matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of zetomipzomib	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.	Baseline through Week 37
To evaluate safety of zetomipzomib	Incidence and severity of adverse event (AE)s for each treatment group and patients treated with zetomipzomib compared with placebo	Baseline through Week 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial Renal Remission (PRR)	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.	Baseline through Week 25, Week 37, and Week 53
CRR	Proportion of patients achieving CRR	Baseline through Week 25 and Week 53

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UPCR	Percentage change from Baseline in UPCR by visit	Baseline through Week 53
Time to event	Time to CRR, PRR, death or renal events	Baseline through Week 53
CRR and successful prednisone taper	Proportion of patients achieving CRR with successful taper of prednisone or equivalent by Week 17	Baseline through Week 25, Week 37, and Week 53
CRR and no prednisone use	Proportion of patients achieving CRR with no use of prednisone or equivalent during the 8 weeks prior to renal response assessment	Baseline through Week 25, Week 37, and Week 53
UPCR ≤0.5	Proportion of patients with UPCR ≤0.5	Baseline through Week 13, Week 25, Week 37, and Week 53
CRR with UPCR ≤ ULN	Proportion of patients achieving CRR with UPCR ≤ Upper Limit of Normal	Baseline through Week 25, Week 37, and Week 53
Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K)	Changes from Baseline in clinical SLEDAI-2K score. The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity.	Baseline through Week 56
Change in Patient-reported Outcomes	Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) assessment. The EQ-5D-5L descriptive system comprises five dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression), each with five response levels (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). A higher score in each category indicates a higher level of patient-reported dysfunction or discomfort.	Baseline through Week 56

Collaborators and Investigators

• Sponsor: Kezar Life Sciences, Inc.
• Investigators: Principal Investigator: Steven Kimmel, MD, West Broward Rheumatology Associates, Inc.; Principal Investigator: Sumit Kumar, MD, Texas Kidney Institute; Principal Investigator: Amarilis Gonzalez, MD, Phoenix Research Center, LLC; Principal Investigator: David Tietjen, MD, Nephrology Consultants, LLC

Publications and helpful links

Helpful Links

• Corporate website

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 12, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: steroids; glucocorticoids; complete renal response; immunoproteasome inhibition; selective immunoproteasome inhibition; partial renal response; SLE (systemic lupus erythematosus; UPCR (urine protein to creatinine ratio); eGFR (estimated glomerular filtration rate)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis
• Other Study ID Numbers: KZR-616-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No