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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781750
Other study ID # KZR-616-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 3, 2023
Est. completion date July 2026

Study information

Verified date June 2024
Source Kezar Life Sciences, Inc.
Contact Kezar Life Sciences, Inc
Phone (650) 640-4480
Email PALIZADE@kezarbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Recruiting
Enrollment 279
Est. completion date July 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
zetomipzomib
Subcutaneous injection of zetomipzomib
placebo
Subcutaneous injection of placebo

Locations

Country Name City State
Argentina Aprillus Assistance and Research by Arcis Health Buenos Aires
Argentina Dr. Doreski Medical Offices Buenos Aires
Argentina Framingham Medical Center Buenos Aires
Argentina Medical Research Organization Buenos Aires
Argentina Military Central Hospital Buenos Aires
Argentina Austral University Hospital Pilar
Argentina The Medical Institute of the Clinical Studies Foundation Rosario Santa Fe
Argentina Mayo Clinic of UCMB SRL San Miguel De Tucumán Tucumán
Australia Monash Health Clayton Victoria
Australia Canberra Hospital Garran Australian Capital Territory
Australia St George Hospital Kogarah New South Wales
Australia John Hunter Hospital New Lambton Heights New South Wales
Australia Royal Melbourne Hospital Parkville Victoria
Australia Gold Coast Hospital and Health Service Southport Queensland
Australia Sunshine Hospital St Albans Victoria
Australia Wollongong Hospital Wollongong New South Wales
Brazil Holy House of Mercy of Belo Horizonte Belo Horizonte Minas Gerais
Brazil Brasília Hospital Brasília Federal District
Brazil L2IP - Clinical Research Institute Brasília Distrito Federal
Brazil Pro-Renal Institute Brazil Curitiba Paraná
Brazil Pro-Rim Foundation Research Center Joinville Santa Catarina
Brazil Hospital Association Clinical Research Center - Windmills Hospital Porto Alegre Rio Grande Do Sul
Brazil LMK Medical Services SS Porto Alegre Rio Grande Do Sol
Brazil Clinics Hospital FMRP Ribeirão Preto São Paulo
Brazil Hospital São Lucas Copacabana Rio De Janeiro
Brazil Senhor de Bonfim Clinic Salvador Bahia
Brazil Specialized Rheumatology Services of Bahia Salvador Bahia
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 Domingos São Luís Maranhão
Brazil Clinical Hospital FMUSP São Paulo
Brazil Hospital Nove de Julho São Paulo
Brazil Oswaldo Ramos Foundation São Paulo
Brazil Saint Marcelina Hospital São Paulo
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
China Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Colombia Costa Clinica Barranquilla Atlántico
Colombia Cardiovascular Foundation of Colombia Bucaramanga Santander
Colombia Healthy Medical Center S.A.S. Zipaquirá Cundinamarca
Croatia University Hospital of Split Split
Croatia Solmed Clinic Zagreb
Croatia University Hospital Center Zagreb Zagreb
Greece Laiko General Hospital of Athens Athens
Greece Laiko General Hospital of Athens Athens
Greece University General Hospital of Larisa Larisa
Greece Ippokratio General Hospital of Thessaloniki Thessaloniki
Guatemala Center for Advanced Health Clinical Studies Guatemala
Guatemala Clinical Research Center, S.A. Guatemala
Guatemala Medical Clinic Specialized in Nephrology Guatemala
Guatemala Medical Clinic Specialized in Internal Medicine and Rheumatology Guatemala City
Guatemala Medical Clinic Specialized in Internal Medicine and Rheumatology Guatemala City
India Panchshil Hospital Ahmedabad Gujarat
India MGM Medical College and Hospital Aurangabad Maharashtra
India KLES Dr Prabhakar Kore Hospital and Medical Research Centre Belgaum Karnataka
India Yashoda Hospitals Hyderabad Telangana
India SMS Medical College Jaipur Rajasthan
India Fortis Hospital Kolkata West Bengal
India Jasleen Hospital Nagpur Maharashtra
India Kingsway Hospital Nagpur Maharashtra
India Assured Care Plus Hospital Nashik Maharashtra
India Sir Ganga Ram Hospital New Delhi NCT Of Delhi
India All India Institute of Medical Sciences Raipur Chhattisgarh
India Krishna Institute of Medical Science Secunderabad Telangana
India Nirmal Hospital Surat Guajrat
India Unity Hospital Surat Guajrat
India Elite Mission Hospital Thrissur Kerala
Korea, Republic of CHA Bundang Medical Center, CHA University Gyeonggi-do
Korea, Republic of 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
Malaysia Hospital Selayang Batu Caves Selangor
Malaysia Hospital Raja Permaisuri Bainun Ipoh Perak
Malaysia Hospital Sultan Idris Shah Serdang Kajang Selangor
Malaysia Hospital Canselor Tuanku Muhriz UKM Kuala Lumpur Wilayah Persekutuan
Malaysia Prince Court Medical Centre Kuala Lumpur Wilayah Persekutuan
Malaysia University Malaya Medical Centre Kuala Lumpur
Malaysia Hospital Al Sultan Abdullah Kuala Selangor
Malaysia Hospital Tengku Ampuan Afzan Kuantan Pahang
Philippines Iloilo Doctors' Hospital Iloilo City Iloilo
Philippines Mary Mediatrix Medical Center Lipa City Batangas
Philippines University of Santo Tomas Hospital Manila
Philippines Chinese General Hospital Manila City National Capital Region
Philippines ManilaMed - Medical Center Manila Manila City National Capital Region
Philippines Far Eastern University Hospital Nicanor Reyes Medical Foundation Quezon City National Capital Region
Philippines St. Luke's Medical Center Quezon City National Capital Region
Philippines St. Luke's Medical Center Quezon City National Capital Region
Portugal 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
Puerto Rico GCM Medical Group San Juan
Singapore National University Hospital Singapore
Singapore Tan Tock Seng Hospital Singapore
South Africa Arthritis Clinical Trial Centre Cape Town Western Cape
South Africa CRISMO Research Centre Germiston Gauteng
South Africa Phoenix Pharma Port Elizabeth Eastern Cape
Spain Clinical Hospital of Barcelona Barcelona
Spain Puigvert Foundation Barcelona
Spain Bellvitge University Hospital L'Hospitalet De Llobregat 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 University of Navarra Hospital Pamplona Navarra
Spain Virgen del Rocío University Hospital Sevilla
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital Keelung
Taiwan Far Eastern Memorial Hospital New Taipei
Taiwan China Medical University Hospital Taichung
Taiwan Chang Gung Memorial Hospital, Linkou Taoyuan
United Kingdom Royal Derby Hospitals, University Hospitals of Derby and Burton Derby Derbyshire
United Kingdom Churchill Hospital Headington Oxford
United Kingdom Leicester General Hospital Leicester
United Kingdom Hammersmith Hospital London
United Kingdom King's College Hospital London UK
United Kingdom St. Georges University Hospitals London
United Kingdom Salford Royal NHS Foundation Trust Salford Greater Manchester
United Kingdom Sunderland Royal Hospital Sunderland Tyne And Wear
United States Northwestern University Chicago Illinois
United States Precision Comprehensive Clinical Research Solutions Colleyville Texas
United States ClinCept Clinical Research Columbus Georgia
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Texas Kidney Institute Dallas Texas
United States Southeast Kidney Associates East Point Georgia
United States Nephrology Associates, Inc East Providence Rhode Island
United States Northwell Health Great Neck New York
United States Prolato Clinical Research Center (PCRC) Houston Texas
United States Nephrology Consultants, LLC Huntsville Alabama
United States Accurate Clinical Research - Lake Charles Lake Charles Louisiana
United States Clinical Renal Associates Langhorne Pennsylvania
United States North Texas Kidney Disease Associates Lewisville Texas
United States Valerius Medical Group and Research Center of Greater Long Beach, Inc. Los Alamitos California
United States Phoenix Research Center, LLC Miami Florida
United States Reliant Medical Research Miami Florida
United States NYU Langone Health New York New York
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States Elixia Central Florida Orlando Florida
United States Renal Specialists of Houston Pasadena Texas
United States Hypertension and Nephrology Inc Providence Rhode Island
United States Southwest Kidney Institute Surprise Arizona
United States West Broward Rheumatology Associates, Inc. Tamarac Florida
United States The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Clinical Renal Associates, Ltd. Upland Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Kezar Life Sciences, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  China,  Colombia,  Croatia,  Greece,  Guatemala,  India,  Korea, Republic of,  Malaysia,  Philippines,  Portugal,  Puerto Rico,  Singapore,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in UPCR Percentage change from Baseline in UPCR by visit Baseline through Week 53
Other Time to event Time to CRR, PRR, death or renal events Baseline through Week 53
Other 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
Other 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
Other UPCR =0.5 Proportion of patients with UPCR =0.5 Baseline through Week 13, Week 25, Week 37, and Week 53
Other CRR with UPCR = ULN Proportion of patients achieving CRR with UPCR = Upper Limit of Normal Baseline through Week 25, Week 37, and Week 53
Other 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
Other 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
Primary 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
Primary 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 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
Secondary CRR Proportion of patients achieving CRR Baseline through Week 25 and Week 53
See also
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