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Study of Ravulizumab for Adults with Lupus Nephritis or IgA Nephropathy

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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 two kidney-related diseases: Lupus Nephritis and Immunoglobulin A Nephropathy. The treatment being tested is a medication called Ravulizumab, which is also known by its code name ALXN1210. The purpose of the study is to evaluate how effective and safe Ravulizumab is for adults with these conditions compared to a placebo.

Participants in the study will receive either Ravulizumab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which participants will be monitored to see how their condition responds to the treatment. The main focus will be on changes in protein levels in the urine, which is a key indicator of kidney health. Other aspects of kidney function and overall health will also be assessed.

This study is designed to help understand whether Ravulizumab can improve the health of people with Lupus Nephritis or Immunoglobulin A Nephropathy. By comparing the effects of the medication to a placebo, researchers aim to gather important information that could lead to better treatment options for these kidney diseases in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is required to meet specific criteria, including being between 18 and 75 years of age, having proteinuria of at least 1 g/d or g/g, and being vaccinated against certain infections.

    Participants with Lupus Nephritis (LN) must have a diagnosis of active focal or diffuse proliferative LN Class III or IV and be receiving immunosuppression treatment. Participants with Immunoglobulin A Nephropathy (IgAN) must have a diagnosis of primary IgAN and be on a stable dose of RAS inhibitor treatment for at least 3 months.

  2. Step 2

    Treatment administration

    Participants receive the medication ravulizumab, which is administered as an intravenous infusion. The product used is Ultomiris 300 mg/30 mL concentrate for solution for infusion.

    The frequency and duration of the administration are determined by the study protocol and are designed to evaluate the efficacy and safety of the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess the treatment's impact. This includes measuring the percentage change in proteinuria and changes in eGFR (estimated Glomerular Filtration Rate).

    For participants with LN, additional assessments include the percentage of participants meeting criteria for Complete or Partial Renal Response, time to achieve a specific Urine Protein to Creatinine Ratio, and the percentage achieving corticosteroid tapering.

  4. Step 4

    Completion of the study

    The study is estimated to conclude by May 26, 2026. Upon completion, the data collected will be analyzed to determine the efficacy of ravulizumab in treating the specified conditions.

    Participants will be informed of the study's outcomes and any relevant findings related to their health condition.

Who can join the trial?

10 criteria

  • Must be between 18 and 75 years old.
  • Must have **proteinuria** of 1 or more. Proteinuria means having too much protein in the urine.
  • Must be vaccinated against **meningococcal infection**, which is a type of bacterial infection.
  • Must be vaccinated against **Haemophilus influenzae type b (Hib)** and **Streptococcus pneumoniae**, which are types of bacteria that can cause infections.
  • For those with **Lupus Nephritis (LN)**:
  • Must have a diagnosis of active **focal or diffuse proliferative LN Class III or IV**. This refers to specific types of kidney inflammation caused by lupus.
  • Must have clinically active LN that requires or is receiving treatment to suppress the immune system.
  • For those with **Immunoglobulin A Nephropathy (IgAN)**:
  • Must have a diagnosis of primary IgAN, which is a kidney disease caused by deposits of a protein called immunoglobulin A.
  • Must be following a stable and optimal dose of **RAS inhibitor treatment** for at least 3 months. RAS inhibitors are medications that help control blood pressure and protect the kidneys.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to the study medication or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of certain types of cancer, unless they have been in remission for a specified period.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication.
  • Patients with severe liver disease, which affects how the liver functions.
  • Patients who are pregnant or breastfeeding.
  • Patients with certain infections that are not well-controlled, such as active tuberculosis.
  • Patients who have received certain vaccines within a specific time frame before the study.
  • Patients with a history of drug or alcohol abuse that could interfere with the study.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Ravulizumab is a medication being studied for its effectiveness and safety in treating adults with certain kidney conditions, specifically Proliferative Lupus Nephritis (LN) and Immunoglobulin A Nephropathy (IgAN). It works by targeting a part of the immune system to help reduce inflammation and prevent further damage to the kidneys.

What is already known about the treatment

Ravulizumab – Ravulizumab is administered through intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating conditions like Lupus Nephritis and Immunoglobulin A Nephropathy. These are kidney-related diseases where the immune system attacks the body's own tissues. Ravulizumab works by inhibiting a part of the immune system known as the complement system, which plays a role in inflammation and tissue damage. It belongs to a class of medications called complement inhibitors.

Investigated diseases

  • Lupus Nephritis

    Lupus Nephritis is a kidney disorder that occurs as a complication of systemic lupus erythematosus, an autoimmune disease. In this condition, the immune system mistakenly attacks the kidneys, leading to inflammation and potential damage. Over time, this can result in impaired kidney function, causing symptoms such as swelling, high blood pressure, and protein in the urine. The progression of the disease can vary, with periods of flare-ups and remission. It is crucial to monitor kidney function regularly to manage the condition effectively.

  • Immunoglobulin A Nephropathy

    Immunoglobulin A Nephropathy, also known as IgA Nephropathy, is a kidney disease characterized by the buildup of the antibody immunoglobulin A in the kidneys. This accumulation can cause inflammation and damage to the kidney tissues, leading to symptoms like blood in the urine, proteinuria, and sometimes swelling in the hands and feet. The disease progresses slowly, and its course can vary significantly among individuals. Regular monitoring of kidney function is essential to understand the disease's impact and manage its progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507977-16-00Protocol codeALXN1210-NEPH-202Estimated enrolment145 patientsSponsorAlexion Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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