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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05781750
Registration number
NCT05781750
Ethics application status
Date submitted
12/03/2023
Date registered
23/03/2023
Titles & IDs
Public title
A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)
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Scientific 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
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Secondary ID [1]
0
0
KZR-616-202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis
0
0
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Condition category
Condition code
Renal and Urogenital
0
0
0
0
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Other renal and urogenital disorders
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - zetomipzomib
Treatment: Drugs - placebo
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.
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.
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.
Treatment: Drugs: zetomipzomib
Subcutaneous injection of zetomipzomib
Treatment: Drugs: placebo
Subcutaneous injection of placebo
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
To evaluate the efficacy of zetomipzomib
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Assessment method [1]
0
0
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.
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Timepoint [1]
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0
Baseline through Week 37
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Primary outcome [2]
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0
To evaluate safety of zetomipzomib
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Assessment method [2]
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Incidence and severity of adverse event (AE)s for each treatment group and patients treated with zetomipzomib compared with placebo
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Timepoint [2]
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Baseline through Week 56
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Secondary outcome [1]
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Partial Renal Remission (PRR)
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Assessment method [1]
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0
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.
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Timepoint [1]
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Baseline through Week 25, Week 37, and Week 53
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Secondary outcome [2]
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CRR
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Assessment method [2]
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Proportion of patients achieving CRR
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Timepoint [2]
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Baseline through Week 25 and Week 53
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Eligibility
Key inclusion criteria
Key
* 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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
279
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Canberra Hospital - Garran
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St George Hospital - Kogarah
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John Hunter Hospital - New Lambton Heights
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Wollongong Hospital - Wollongong
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Gold Coast Hospital and Health Service - Southport
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Monash Health - Clayton
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Royal Melbourne Hospital - Parkville
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Sunshine Hospital - St Albans
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2605 - Garran
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2217 - Kogarah
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2305 - New Lambton Heights
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2500 - Wollongong
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4215 - Southport
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3168 - Clayton
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3050 - Parkville
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3021 - St Albans
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Kezar Life Sciences, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT05781750
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Steven Kimmel, MD
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Address
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West Broward Rheumatology Associates, Inc.
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Contact person for public queries
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Kezar Life Sciences, Inc
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Phone
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(650) 640-4480
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05781750