Lupus NephritisPhase 2NCT05781750

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

A Phase 2 study testing zetomipzomib in people with Lupus Nephritis, run by Kezar Life Sciences, Inc. at 50 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study was 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lupus Nephritis
What is being tested?: zetomipzomib
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 50 sitesin 12 countries
Study dates: 3 Nov 2023to 8 Nov 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

50 sites in 12 countries.

Country

City, postcode or hospital

50 sites in 12 countries

India13 sites

Panchshil Hospital
Ahmedabad, Gujarat, 380005
MGM Medical College and Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431003
Yashoda Hospitals
Hyderabad, Telangana, India
SMS Medical College
Jaipur, Rajasthan, 302001
Kingsway Hospital
Nagpur, Maharashtra, 440001
Jasleen Hospital
Nagpur, Maharashtra, 440012
Assured Care Plus Hospital
Nashik, Maharashtra, 422101
Sir Ganga Ram Hospital
New Delhi, NCT of Delhi, 110060
All India Institute of Medical Sciences
Raipur, Chhattisgarh, 492099
Krishna Institute of Medical Science
Secunderabad, Telangana, 500003
Nirmal Hospital
Surat, Guajrat, 395002
Unity Hospital
Surat, Guajrat, 395010
Elite Mission Hospital
Thrissur, Kerala, 680007

Other trials in India

Argentina7 sites

Framingham Medical Center
Buenos Aires, B1902ADW
Medical Research Organization
Buenos Aires, C1015
Aprillus Assistance and Research by Arcis Health
Buenos Aires, C1406AGA
Dr. Doreski Medical Offices
Buenos Aires, C1426ABP
Military Central Hospital
Buenos Aires, C1426BOS
Austral University Hospital
Pilar, B1629ODT
Mayo Clinic of UCMB SRL
San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

Philippines6 sites

Iloilo Doctors' Hospital
Iloilo City, Iloilo, 5000
Mary Mediatrix Medical Center
Lipa City, Batangas, 4217
ManilaMed - Medical Center Manila
Manila, National Capital Region, 1000
University of Santo Tomas Hospital
Manila, 1015
St. Luke's Medical Center
Quezon City, National Capital Region, 1102
Far Eastern University Hospital Nicanor Reyes Medical Foundation
Quezon City, National Capital Region, 1118

Other trials in Philippines

Malaysia5 sites

Hospital Selayang
Batu Caves, Selangor, 68100
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30450
Hospital Sultan Idris Shah Serdang
Kajang, Selangor, 43000
Prince Court Medical Centre
Kuala Lumpur, Kuala Lumpur, 50450
University Malaya Medical Centre
Kuala Lumpur, 59100

Other trials in Malaysia

United States4 sites

Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
Nephrology Associates, Inc
East Providence, Rhode Island, 02914
Prolato Clinical Research Center (PCRC)
Houston, Texas, 77054
Accurate Clinical Research - Lake Charles
Lake Charles, Louisiana, 70605

Other trials in United States

Brazil4 sites

Holy House of Mercy of Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221
Clinics Hospital FMRP
Ribeirão Preto, São Paulo, 14051-140
Faculty of Medicine of SJRP
São José do Rio Preto, São Paulo, 15090-000
Clinical Hospital FMUSP
São Paulo, 05403-000

Other trials in Brazil

Guatemala4 sites

Center for Advanced Health Clinical Studies
Guatemala City, 01009
Clinical Research Center, S.A.
Guatemala City, 01010
Medical Clinic Specialized in Internal Medicine and Rheumatology
Guatemala City, 01010
Medical Clinic Specialized in Internal Medicine and Rheumatology
Guatemala City, 01011

Other trials in Guatemala

China3 sites

Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036

Other trials in China

Colombia1 site

Costa Clinica
Barranquilla, Atlántico, 080020

Other trials in Colombia

Greece1 site

Laiko General Hospital of Athens
Athens, 11527

Other trials in Greece

South Africa1 site

Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001

Other trials in South Africa

South Korea1 site

The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591

Other trials in South Korea

About this study

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

Read the detailed description

This study aimed to investigate whether zetomipzomib, added to standard of care treatment in patients with active LN, was able to reduce disease activity over a treatment period of 52 weeks. The background standard of care therapy was mycophenolate mofetil (MMF) and initial optional treatment with IV methylprednisolone, followed by a tapering course of oral corticosteroids.

Patients were required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis.

Patients were 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 was to 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 was also assessed throughout the study to ensure an acceptable safety profile.

Conditions: Lupus Nephritis
Being tested: zetomipzomib, placebo
Keywords: immunoproteasome inhibition, selective immunoproteasome inhibition, complete renal response, partial renal response, glucocorticoids, steroids, SLE (systemic lupus erythematosus), UPCR (urine protein to creatinine ratio), eGFR (estimated glomerular filtration rate)
Medical subject headings: Lupus Nephritis, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

zetomipzomibDrug
Also called KZR-616
Subcutaneous injection of zetomipzomib
placeboDrug
Also called matching placebo
Subcutaneous injection of placebo

Study groups in NCT05781750
Study group	Role	What they receive
zetomipzomib 30 mg + standard-of-care	Experimental	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy. Receives: Drug: zetomipzomib
zetomipzomib 60 mg + standard-of-care	Experimental	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy. Receives: Drug: zetomipzomib
placebo + standard-of-care	Placebo comparator	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Achieving Complete Renal Response
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.
Measured: Week 37

Secondary outcomes (6)

Proportion of Patients Achieving Partial Renal Response (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.
Measured: Week 25 and Week 37
Proportion of Patients Achieving Complete Renal Response
Proportion of patients achieving complete renal response (CRR)
Measured: Week 25
Change in UPCR
Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit
Measured: Week 13, Week 25, and Week 37
Time to Complete Renal Response and Partial Renal Response
The comparison of the time to Complete Renal Response and Partial Renal Response for the zetomipzomib treatment groups (zetomipzomib 30mg and zetomipzomib 60mg) versus placebo. Hazard ratio (HR) and associated two-sided CIs are estimated using the Cox proportional hazards model. The model includes terms for treatment, the randomization stratification factors, and baseline UPCR (continuous).
Measured: Baseline through Week 37
Proportion of Patients With UPCR ≤0.5
Proportion of patients with UPCR ≤0.5
Measured: Week 13, Week 25, and Week 37
Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K)
Percent change from Baseline in clinical SLEDAI-2K score. The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity.
Measured: Week 13, Week 25, and Week 37

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 20238 Nov 2024

First posted23 Mar 2023
Study start3 Nov 2023
Primary completion8 Nov 2024
Study completion8 Nov 2024

Why it stopped: Sponsor Decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lupus NephritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05781750
Sponsor's protocol ID: KZR-616-202
Status last verified: Nov 2025
First submitted: 12 Mar 2023
Last updated: 5 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

All Lupus Nephritis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05781750
Acronym / sponsor ID: KZR-616-202
Conditions: Lupus Nephritis
Keywords: immunoproteasome inhibition, selective immunoproteasome inhibition, complete renal response, partial renal response, glucocorticoids, steroids, SLE (systemic lupus erythematosus), UPCR (urine protein to creatinine ratio)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor Decision.
Enrolment: 84 participants (actual)
Lead sponsor: Kezar Life Sciences, Inc.Industry (pharma, biotech, devices)
Study start: 3 Nov 2023 (actual)
Primary completion: 8 Nov 2024 (actual)
Study completion: 8 Nov 2024 (actual)
First posted: 23 Mar 2023 (actual)
Results: Posted 5 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Patients were required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
zetomipzomib 30 mg + standard-of-care	Experimental	Drug: zetomipzomibParticipants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
zetomipzomib 60 mg + standard-of-care	Experimental	Drug: zetomipzomibParticipants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
placebo + standard-of-care	Placebo comparator	Drug: placeboParticipants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (10 listed)

Current or medical history of:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
zetomipzomibAlso: KZR-616Subcutaneous injection of zetomipzomib	Drug	zetomipzomib 30 mg + standard-of-care, zetomipzomib 60 mg + standard-of-care
placeboAlso: matching placeboSubcutaneous injection of placebo	Drug	placebo + standard-of-care

Primary outcome

Proportion of Patients Achieving Complete Renal Response
Time frame: Week 37
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.

6 secondary outcomes

Proportion of Patients Achieving Partial Renal Response (PRR)
Time frame: Week 25 and Week 37
Proportion of Patients Achieving Complete Renal Response
Time frame: Week 25
Change in UPCR
Time frame: Week 13, Week 25, and Week 37
Time to Complete Renal Response and Partial Renal Response
Time frame: Baseline through Week 37
Proportion of Patients With UPCR ≤0.5
Time frame: Week 13, Week 25, and Week 37
Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K)
Time frame: Week 13, Week 25, and Week 37

Results and safety

Results posted to the registry on 5 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zetomipzomib 30 mg + Standard-of-care	27	0
Zetomipzomib 60 mg + Standard-of-care	29	0
Placebo + Standard-of-care	28	0

Primary outcome: Proportion of Patients Achieving Complete Renal Response

Time frame: Week 37. Count of participants. Unit: Participants

Measure	Zetomipzomib 30 mg + Standard-of-care n = 4	Zetomipzomib 60 mg + Standard-of-care n = 6	Placebo + Standard-of-care n = 6
Value	0	1	0

Population analysed: Participants in the intent to treat analysis set who reached Week 37 of treatment. Intent-to-treat set was defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the 37 week timepoint for efficacy analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through end of study visit, up to 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zetomipzomib 30 mg + Standard-of-care	5 of 27 (18.5%)	23 of 27 (85.2%)	2 of 27
Zetomipzomib 60 mg + Standard-of-care	8 of 29 (27.6%)	25 of 29 (86.2%)	1 of 29
Placebo + Standard-of-care	3 of 28 (10.7%)	17 of 28 (60.7%)	1 of 28

Limitations and caveats (from the sponsor): The study was terminated early for strategic business reasons following the temporary halt of the study per the Independent Data Monitoring Committee's (IDMC's) recommendation. At the time of termination, no participants had completed the full 52-week treatment period. Due to early termination, safety was the primary focus of this study and only limited efficacy data were analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Corporate websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Lupus Nephritis

RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kezar study director

Kezar Life Sciences, Inc.

50 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing zetomipzomib in people with Lupus Nephritis, run by Kezar Life Sciences, Inc. at 50 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in India, Argentina, Philippines, Malaysia, United States and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Achieving Complete Renal Response (time frame: Week 37). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05781750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.