Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on the Effectiveness and Safety of Ravulizumab for Adults with Corticosteroid-Resistant IgA Nephropathy Flares

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 kidney disease called IgA nephropathy, which is a condition where the immune system causes inflammation and damage to the kidneys. The study is testing a treatment using a medication called ravulizumab, which is given as an infusion directly into the bloodstream. The purpose of the study is to see if this medication can help reduce the symptoms of the disease, specifically the levels of protein and blood in the urine, in patients who have not responded well to standard treatments like corticosteroids.

Participants in the study will receive the treatment with ravulizumab over a period of six months. During this time, the study will monitor changes in the levels of protein and blood in the urine to assess the effectiveness of the treatment. The study will also look at how the treatment affects kidney function and whether any side effects occur. After the six-month treatment period, participants will continue to be observed for an additional four months to see how their condition evolves after stopping the medication.

This study aims to provide valuable information on the safety and effectiveness of ravulizumab for treating IgA nephropathy in patients who have not had success with other treatments. The results could help improve understanding of how to manage this challenging condition and offer new hope for those affected by it.

The research process

The trial runs in 6 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 must be at least 18 years old and capable of providing written consent.

    The participant should have a previous biopsy confirming idiopathic IgA nephropathy and show persistent symptoms despite standard treatment.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the participant's eligibility, including the evaluation of renal function and the presence of specific symptoms such as proteinuria and haematuria.

    Vaccination against meningococcus, haemophilus, and pneumococcus is required before starting the treatment.

  3. Step 3

    Treatment initiation

    The treatment involves the administration of ravulizumab through an intravenous infusion.

    The medication used is Ultomiris 300 mg/30 mL concentrate for solution for infusion.

  4. Step 4

    Treatment duration

    The treatment with ravulizumab will last for 6 months.

    During this period, the participant will receive regular infusions as per the study protocol.

  5. Step 5

    Monitoring and evaluation

    Throughout the study, the participant's proteinuria and haematuria levels will be monitored using 24-hour urine collections.

    Serum creatinine levels and urine C5b-9 levels will also be measured to assess kidney function.

  6. Step 6

    Post-treatment follow-up

    After the 6-month treatment period, the participant will be monitored for an additional 20 weeks to evaluate the evolution of symptoms and kidney function.

    The study aims to measure the percentage of participants achieving complete remission and the proportion discontinuing treatment due to adverse effects.

Who can join the trial?

11 criteria

  • Participant must be at least 18 years old and able to give consent.
  • Must provide written consent to participate.
  • Must have a previous biopsy showing **idiopathic IgA nephropathy** (a kidney condition).
  • Must have ongoing symptoms despite standard treatment:
    • For those with normal kidney function: **Proteinuria** (protein in urine) greater than 1 gram per gram and **haematuria** (blood in urine) more than 15 cells per microliter after 6 months of treatment with **corticosteroids** (a type of medication).
    • For those with **acute kidney injury** (sudden kidney damage): ongoing blood and protein in urine and no improvement in kidney function 4 weeks after starting treatment with corticosteroids.
    • Must show evidence of **mesangial deposition of C5b-9** (a specific protein deposit in the kidney) with or without **capillary deposits of C3d** (another protein deposit).
    • Must be vaccinated against **meningococcus**, **haemophilus**, and **pneumococcus** (types of bacteria).
    • If taking **SGLT-2 inhibitors** (a type of diabetes medication), must be on a stable dose for at least 3 months before the study and not plan to change the dose during the study.
    • Must be on a stable and optimal dose of **RAS inhibitors** (medications for blood pressure) for at least 3 months before the study with no expected dose changes during the study.
    • Must not have specific reasons that prevent the use of **ravulizumab** (a medication being studied).
    • Female participants who can have children and male participants with female partners who can have children must follow specific contraception guidelines during the study.

Who cannot join the trial?

3 criteria

  • Patients who are not adults. This means anyone under 18 years old cannot participate.
  • Patients who do not have **IgA nephropathy**. This is a kidney condition where a protein called IgA builds up in the kidneys, causing damage.
  • Patients who are part of a vulnerable population. This usually includes groups like pregnant women, children, or people who cannot make decisions for themselves.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Ravulizumab is a medication being studied for its potential to help patients with a kidney condition called IgA nephropathy, which does not respond well to corticosteroids. This medication is being tested to see if it can reduce the levels of protein and blood in the urine, which are common problems in this condition. The study aims to evaluate the safety and effectiveness of using Ravulizumab over a six-month period for patients experiencing flare-ups of this kidney disease.

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 IgA nephropathy, particularly in patients who do not respond to corticosteroids. The main therapeutic indication for Ravulizumab in this context is to reduce proteinuria and hematuria, which are common symptoms of IgA nephropathy. At the molecular level, Ravulizumab works by inhibiting a part of the immune system known as the complement system, which can contribute to inflammation and kidney damage. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

IgA nephropathy – IgA nephropathy is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation. This buildup can cause damage to the kidney tissues, affecting their ability to filter waste from the blood. Over time, this condition may result in blood and protein appearing in the urine, known as haematuria and proteinuria, respectively. The disease often progresses slowly, and symptoms may not be noticeable in the early stages. As the condition advances, individuals might experience swelling in the hands and feet, high blood pressure, and changes in urine color. The progression of IgA nephropathy varies among individuals, with some experiencing only mild symptoms while others may develop more severe kidney damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512154-24-00Protocol codeRAV-IgAEstimated enrolment15 patientsSponsorInstitut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.