Lupus Nephritis Clinical Trial
Official title:
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Kezar Life Sciences, Inc. |
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,
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 |
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