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Study on Zetomipzomib for Patients with Active Lupus Nephritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Lupus Nephritis, which is a type of kidney inflammation caused by an autoimmune disease known as Systemic Lupus Erythematosus. The study is testing a new treatment called Zetomipzomib (KZR-616), which is a small molecule designed to inhibit the immunoproteasome, a part of the immune system that can contribute to inflammation. The purpose of the study is to evaluate the effectiveness and safety of Zetomipzomib in patients with active forms of Lupus Nephritis, specifically Class III or IV, with or without Class V, and pure Class V.

Participants in the study will receive either Zetomipzomib or a placebo, which is a substance with no active medication. The study will compare the outcomes of those receiving Zetomipzomib to those receiving the placebo. The treatment will be administered as a subcutaneous injection, which means it is injected under the skin. The study will last for about a year, during which participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, the main goal is to see how many patients achieve a complete renal response, which means their kidney function improves significantly. The study will also look at other outcomes, such as partial renal response and changes in disease activity. This research aims to provide new insights into treating Lupus Nephritis and potentially offer a new treatment option for patients with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a renal biopsy if not performed within the last 12 months.

    Eligibility criteria include a body mass index of at least 18 kg/m², adequate kidney function, and a positive test for specific antibodies related to lupus nephritis.

  2. Step 2

    Treatment phase

    The treatment phase involves the administration of zetomipzomib (KZR-616) or a placebo. The medication is given as a subcutaneous injection.

    Dosage options include 30 mg or 60 mg, administered once weekly. The duration of this phase is up to 53 weeks.

  3. Step 3

    Concomitant medication

    During the trial, additional medications may be prescribed. These include methylprednisolone administered intravenously and mycophenolate mofetil taken orally as 500 mg film-coated tablets.

    The use of these medications is determined by the study protocol and the patient's response to treatment.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted throughout the trial. These include blood tests, urine tests, and evaluations of kidney function.

    The primary goal is to assess the proportion of patients achieving complete renal response (CRR) at Week 37.

  5. Step 5

    Follow-up

    After the treatment phase, a follow-up period is conducted to monitor long-term effects and gather additional data.

    The study aims to evaluate the safety and efficacy of the treatment over an extended period, with key assessments at Weeks 25, 37, and 53.

Who can join the trial?

10 criteria

  • Must have an **autoimmune disease**. This is a condition where the body's immune system mistakenly attacks its own cells.
  • Must be diagnosed with **Lupus Nephritis (LN)**, a kidney inflammation caused by lupus, according to specific medical criteria from 2003 or 2018.
  • Must have a **body mass index (BMI)** of at least 18 kg/m². BMI is a measure of body fat based on height and weight.
  • Must have an **eGFR** of at least 30 mL/min/1.73 m². eGFR is a test that measures how well the kidneys are filtering blood.
  • Must have a positive **ANA test** or a positive **anti-dsDNA serum antibody test**. These are blood tests that help diagnose autoimmune diseases.
  • Must have a **renal biopsy** confirming the diagnosis of LN within 12 months before the screening. A renal biopsy is a procedure where a small piece of kidney tissue is removed for examination.
  • Must have a **UPCR** of at least 1.0 for Class III/IV LN or at least 2.0 for Class V LN. UPCR is a test that measures protein levels in urine, indicating kidney function.
  • Must have adequate **hematologic, hepatic, and renal function**. This means the blood, liver, and kidneys are working well enough.
  • Both **male and female** participants are eligible.
  • Participants must be within the specified age range, which includes adults and adolescents.

Who cannot join the trial?

1 criterion

  • Having an autoimmune disease. This is when the body's defense system attacks its own healthy cells by mistake.
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Investigated drugs

Zetomipzomib (KZR-616) is a medication being studied for its effectiveness and safety in treating patients with active lupus nephritis, a kidney condition associated with lupus. The trial aims to determine how well this medication works in reducing the symptoms and progression of the disease in patients with different classes of lupus nephritis.

What is already known about the treatment

Zetomipzomib – Zetomipzomib is administered as an injection and is currently being studied in clinical trials for its effectiveness and safety in treating lupus nephritis, a type of autoimmune disease affecting the kidneys. It is in the Phase 2b stage of clinical trials, indicating that it is still under investigation and not yet widely available for general medical use. The medication works by modulating the immune system to reduce inflammation and damage to kidney tissues. Zetomipzomib is classified as an immunomodulatory agent, which means it alters the immune response to help manage autoimmune conditions.

Investigated diseases

Systemic Lupus Erythematosus – This is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. Over time, it can lead to inflammation and damage in the affected organs. The severity and progression of symptoms can vary widely among individuals. Lupus can have periods of flares, where symptoms worsen, and remissions, where symptoms improve.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502227-22-00Protocol codeKZR-616-202Estimated enrolment247 patientsSponsorKezar Life Sciences Inc.

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