Study of Ravulizumab for Adults with Lupus Nephritis or IgA Nephropathy

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Maastricht	Maastricht	The Netherlands
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hopital Tenon	Paris	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
CHU Gabriel-Montpied	Clermont Ferrand	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Ospedale San Giovanni Bosco	Turin	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital General Universitario De Ciudad Real	Ciudad Real	Spain
Hopital Beaujon	Clichy	France
Universita Degli Studi Di Brescia	Brescia	Italy
Servei De Salut De Les Illes Balears	Palma	Spain
Uwsd Cjssfsat Trcsar Svu z ozni	Lodz	Poland
Uscvpkqaijbpjganydigu Eivuc Auo	Essen	Germany
Udekjcj Umsnxydptq Hezpmvms	Uppsala	Sweden
Ahgppyr Ujpli Smsbruobp Lcyuin Di Bxphxky	Bologna	Italy
Iopirero dd Coeybsacdalq Hvjasplksnh Uvqirzuigaiov dc Sjhed Eljtala (enyfpqj	Saint Priest En Jarez	France
Habrnyiv Vbft dbasoegd	Barcelona	Spain
Hkcjtcql Uoqjdqlakhmmqo Sjirbdseur &mdnefa Hoipxub du Hecfjkronds	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	10.05.2021
Germany	Not recruiting	10.05.2021
Italy	Not recruiting	10.05.2021
Poland	Not recruiting	10.05.2021
Spain	Not recruiting	10.05.2021
Sweden	Not recruiting	10.05.2021
The Netherlands	Not recruiting	10.05.2021

Trial locations

Investigated drugs:

Ravulizumab

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.

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 ID:

2023-507977-16-00

Protocol code:

ALXN1210-NEPH-202

NCT ID:

NCT04564339

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ravulizumab for Adults with Lupus Nephritis or IgA Nephropathy

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