RecruitingPHASE3INTERVENTIONAL

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

This study is investigating a new medication, ravulizumab, for adults living with a kidney disease called IgA Nephropathy (IgAN). IgAN can sometimes lead to kidney damage, and we want to find out if ravulizumab can help slow down or even stop this process. Participants will be given either ravulizumab or a 'dummy' medicine (placebo) through a drip. We will be closely monitoring how well the kidneys are working and looking for changes in a protein found in urine, which can be a sign of kidney problems. The aim is to understand if this new medicine can make a real difference for people at risk of worsening IgAN.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

510

Start

29 Mar 2024

Estimated completion

19 Jul 2030

Immunoglobulin A Nephropathy IgAN

What is this study about?

This study is all about helping people who have a kidney condition called Immunoglobulin A Nephropathy, or IgAN for short. With IgAN, a part of your immune system, called immunoglobulin A, can build up in your kidneys, causing them harm over time. This can make it harder for your kidneys to do their job of filtering waste from your blood.

The main goal of this study is to see if a new medicine called ravulizumab can help. We want to find out if it can reduce the amount of protein leaking into the urine (a sign of kidney damage) and improve how well the kidneys are working overall. We're comparing ravulizumab to a 'placebo', which looks like the medicine but doesn't contain any active ingredients. This helps us understand if any improvements are truly due to ravulizumab or other factors, ensuring our results are reliable.

Taking part in studies like this is really important because it helps scientists and doctors discover new and better ways to treat conditions like IgAN. If ravulizumab proves to be effective, it could offer a new treatment option for many people living with this chronic kidney disease, potentially slowing its progression and improving their long-term health.

Key takeaways

This study is for adults with IgA Nephropathy (IgAN).
It tests a new medicine, ravulizumab, against a dummy medicine (placebo).
The goal is to see if ravulizumab helps kidney function and reduces protein in urine.
Participation involves regular clinic visits and receiving treatment via a drip.
The study lasts over two years, with careful monitoring of your health.

Who may be eligible?

To join this study, you need a confirmed diagnosis of IgAN from a kidney biopsy. Your kidneys should also be working within a certain range. For most participants, your kidney function (eGFR) should be 30 or more. If your kidney function is a bit lower (between 20 and 29), you might still be able to join a special group within the study, but this would need a recent kidney biopsy.

We'll also need to see that you have a certain amount of protein in your urine, which helps us know that your IgAN is active. You also need to be on stable treatment for your IgAN, which means you've been taking the same dose of certain kidney medications for at least three months, and there are no plans to change them during the study.

There are also some reasons you might not be able to join. For example, if your kidney function has dropped very quickly recently, or if your IgAN is caused by another serious condition like lupus. Other reasons include having had a kidney transplant, having certain infections, or if you've recently used strong immune-suppressing medicines.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a confirmed diagnosis of IgAN from a kidney biopsy?
Is your kidney function (eGFR) generally 30 or higher (or 20-29 for a specific group)?
Are you taking stable doses of your regular IgAN medications?
Have you not had a recent rapid worsening of your kidney function?
Have you not had a kidney transplant or certain serious infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to receive either the study medicine, ravulizumab, or a 'dummy' medicine (placebo). You won't know which one you're getting. Both will be given through a drip (intravenous infusion) into your arm. You will continue to take your regular IgAN medications as usual throughout the study.

You'll have regular visits to the clinic for assessments. These will include blood tests, urine tests to check protein levels, and measurements of your kidney function. We'll also check your overall health and any side effects you might experience. These visits will happen over about two years (106 weeks).

After the main part of the study, if you wish, you may have the option to continue receiving ravulizumab in an 'open-label' period, where everyone receives the active medicine. The total duration of your participation in the study, including the follow-up, could be over two years.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and closer monitoring of your health. However, there may also be potential risks, including side effects from the study medicine or discomfort from procedures like blood tests. We will explain all known risks to you in detail before you decide to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (267)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Alabaster, United States· Recruiting
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Phoenix, United States· Recruiting
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Loma Linda, United States· Recruiting
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Los Angeles, United States· Recruiting
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Los Angeles, United States· Recruiting
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Los Angeles, United States· Recruiting
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Orange, United States· Recruiting
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San Diego, United States· Recruiting
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San Francisco, United States· Recruiting
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Stanford, United States· Recruiting
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Torrance, United States· Recruiting
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Valencia, United States· Recruiting

Common questions

What is IgAN?

IgAN, or IgA Nephropathy, is a kidney disease where a protein called IgA builds up in your kidneys, which can damage them over time and affect how well they work.

What is ravulizumab?

Ravulizumab is the new medicine being tested in this study to see if it can help reduce kidney damage and improve kidney function in people with IgAN.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the study medicine but doesn't contain any active drug. It helps us compare the effects of the active medicine.

How will the medicine be given?

The study medicine (ravulizumab or placebo) will be given to you through an intravenous drip, which means it goes directly into a vein in your arm.

How long will the study last?

The main part of the study will last for about 106 weeks, which is a little over two years. There might be an option to continue after that.

How to find out more

Alexion Pharmaceuticals, Inc. (Sponsor)

clinicaltrials@alexion.com 1-855-752-2356 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.