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New drug shows promise for lupus and kidney complications

NCT ID NCT03393013

Disease control Sponsor: Kezar Life Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called KZR-616 (zetomipzomib) in 69 people with lupus, some of whom also had kidney inflammation (lupus nephritis). Participants received weekly injections for 13 or 24 weeks. The main goals were to check safety and see if the drug could reduce protein in the urine, a sign of kidney improvement. The trial is now complete.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KZR-616 (zetomipzomib)
What this could lead to
If successful, this could point toward a new treatment option for lupus and lupus-related kidney inflammation.
What could go wrong
This is an early-phase trial with only 69 participants, so results may not apply to everyone. The drug may cause side effects and may not prove effective in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

69 people

The number who actually took part.

Started

Feb 2018

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Phase 1b: * Fulfilled the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification for SLE * Had a positive antinuclear antibody (ANA) titer, anti-double stranded DNA (dsDNA) antibody titer, or a positive anti-Smith antibody titer * Had active SLE (as indicated by Systemic Lupus Erythematosus Disease Activity Index 2000 \[SLEDAI-2K\] score ≥4), and * Had received at least 1 prior therapy for SLE Phase 2: * Had active proliferative LN (Class III or IV, with or without Class V disease) * Had a UPCR ≥1.0 measured in 24-hour urine collection * Had a histologic diagnosis of LN on renal biopsy within the prior 2 years; for biopsies \> 1 year before the Screening visit, one of the following must also be present at screening: low C3, low C4, or anti-ds-DNA elevated to above normal range * Fulfilled the 2012 SLICC classification for SLE * Had a positive ANA titer, anti-dsDNA antibody titer, or anti-Smith antibody titer, and * Were currently receiving ≥1 immunosuppressive agent at a stable dose and route of administration for ≥8 weeks. If the patient is also on corticosteroids then must be on a stable dose for ≥ 2 weeks prior to Baseline Key Exclusion Criteria: Phase 1b: * Current or medical history of: * Central nervous system manifestations by autoimmune disease * Overlapping autoimmune condition that may affect study assessments/outcomes * Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening * Malignancy of any type, with exceptions for in situ cancer that has been completely excised and certain cancers \>5 years ago * Positive test at Screening for HIV, hepatitis B/C * Major surgery within 4 weeks before signing informed consent form or planned major surgery during the study period Phase 2: * 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 * Malignancy of any type within the last 5 years, with exceptions for appropriately excised and cured cervical carcinoma in situ or excised basal or squamous cell carcinomas of the skin * Has received dialysis within the 52 weeks prior to Screening * Positive test at Screening for HIV, hepatitis B/C * Major surgery within 12 weeks before signing informed consent form or planned major surgery during the study period * Use of investigational therapy or device, and/or participation in an investigational trial \<8 weeks or 5 half-lives, whichever is longer, prior to Baseline; Patients who participated in Phase 1b of KZR-616-002 are excluded from Phase 2

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Conditions

The condition(s) this trial relates to.

lupus nephritis nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus nephritis Systemic lupus erythematosus

Contacts and locations

Locations

  • Academic Medical Research Institute

    Los Angeles, California, 990022, United States

  • Accurate Clinical Management, LLC

    Houston, Texas, 77084, United States

  • Accurate Clinical Research, Inc.

    Houston, Texas, 77034, United States

  • Advent Health Medical Group

    Tampa, Florida, 33614, United States

  • Arthritis Center, Inc

    Palm Harbor, Florida, 34684, United States

  • Bioclinica

    Lodz, 90-368, Poland

  • Centro Integral de Reumatologia SA de CV

    Guadalajara, Jalisco, 44160, Mexico

  • Centro Integral de Reumatologia de Caribe CIRCARIBE S.A.S

    Barranquilla, Atlántico, 080020, Colombia

  • Centro de Investigación Clínica Trujillo E.I.R.L/ Clínica Peruano Americana S.A.

    Trujillo, La Libertad, 13011, Peru

  • Clinica de Artritis Temprana

    Cali, Valle del Cauca Department, 076001, Colombia

  • Clinica de la Costa

    Barranquilla, Atlántico, 080020, Colombia

  • Harmoniya Krasy

    Kyiv, Kyiv Governorate, 01135, Ukraine

  • Hope Clinical Trials, Inc.

    Miami, Florida, 33165, United States

  • Hospital Universitario Dr José Eleuterio Gonzalez

    Monterrey, Nuevo León, 64020, Mexico

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786, United States

  • Instituto Nacional de Cardiología Ignacio Chavez

    Mexico City, 14080, Mexico

  • Instituto Nacional de Ciencias Médicas y Nutricion "Salvador Zubiran"

    Mexico City, 14080, Mexico

  • Investigaciones Clinicas SAC

    Lima, 15023, Peru

  • Kuzbass Clinical Hospital

    Kemerovo, 650066, Russia

  • MedResearch, Inc.

    El Paso, Texas, 79902, United States

  • Medical Center Revma-Med

    Kemerovo, 650070, Russia

  • Medicity SAS

    Santander, Bucaramanga, 680003, Colombia

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • NYU Langone Orthopedic Center - Seligman Center for Advanced Therapeutics

    New York, New York, 10016, United States

  • Northwell Health

    Great Neck, New York, 11021, United States

  • Omega Research Maitland

    Orlando, Florida, 32808, United States

  • Ramesh C. Gupta, MD

    Memphis, Tennessee, 38119, United States

  • SC Nephrology & Hypertension Center, Inc.

    Orangeburg, South Carolina, 29118, United States

  • Servimed S.A.S.

    Bucaramanga, Santander Department, 680003, Colombia

  • SouthCoast Research Center, Inc.

    Miami, Florida, 33136, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Tolyatti City Clinical Hospital #1

    Tolyatti, 445009, Russia

  • Unidad de Investigacion en Reumatologia e Inmunologia Clinica San Juan Bautista

    Lima, 15431, Peru

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

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