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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	24.05.2024

Trial locations

Investigated drugs:

Ravulizumab

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.

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 ID:

2024-512154-24-00

Protocol code:

RAV-IgA

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?