Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double‑blind, Placebo‑controlled, Dose‑finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

This research study is looking into a new medicine called ALXN2050. It's for adults who have one of two kidney conditions: lupus nephritis (LN) or IgA nephropathy (IgAN). The main goal is to find out if ALXN2050 can help reduce the amount of protein that leaks into the urine, which is a sign of kidney damage. Researchers also want to find the best dose and make sure the medicine is safe. Some people will receive ALXN2050, and others will get a 'dummy' tablet (placebo) to fairly compare its effects. This is a Phase 2 study, meaning it's an early step in testing new treatments for these important kidney health issues.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Alexion Pharmaceuticals Inc.

Enrolment target

Start

17 May 2024

Lupus Nephritis (LN) Immunoglobulin A Nephropathy (IgAN)

What is this study about?

This research study is focused on two specific kidney conditions: lupus nephritis (LN) and IgA nephropathy (IgAN). Both conditions involve the kidneys not working as they should, often leading to protein leaking into the urine. This study aims to see if a new medicine, ALXN2050, can help improve how the kidneys function in adults with these conditions.

The main thing researchers want to measure is how much the protein in a person's urine changes after taking the medicine. They will also look at other important things, like how well the kidneys are filtering waste (this is called eGFR), and if the medicine has any side effects. By carefully studying these things, they hope to learn if ALXN2050 could be a helpful treatment in the future.

Some people in the study will receive the active medicine, ALXN2050, while others will receive a 'placebo', which looks like the medicine but contains no active ingredient. This is a common and important way to fairly test if the medicine itself is causing the changes observed. It helps ensure the results are reliable and not just due to other factors.

Key takeaways

Tests a new medicine (ALXN2050) for lupus nephritis and IgA nephropathy.
Main goal is to see if it reduces protein in urine and is safe.
Involves adults aged 18 and over.
Some participants get the medicine, others get a placebo (dummy pill).
Requires regular clinic visits for checks and tests.
Helps advance understanding of these kidney conditions.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

You would need to have been diagnosed with either lupus nephritis (LN) or IgA nephropathy (IgAN). Other specific medical details about your condition would need to be checked by the study doctors to see if you are a good fit.

There might be certain other health conditions or medicines you are taking that would mean you can't join the study. This is to make sure the study is safe for everyone involved and that the results are clear.

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.

Are you 18 years old or older?
Have you been diagnosed with lupus nephritis?
OR have you been diagnosed with IgA nephropathy?
Are you able to attend regular clinic visits?
Are you willing to take tablet medicine as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive the study medicine (ALXN2050) or a placebo. This means you wouldn't get to choose which one you receive. You would need to take tablets regularly as instructed.

Throughout the study, you would have a number of visits to the clinic. During these visits, the study team would check your health, take blood and urine samples, and monitor your kidney function. They would also ask how you are feeling and if you've noticed any changes or side effects. The total length of your participation in the study would be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new investigational treatment that might help your condition, and contributing to medical knowledge that could help others in the future. However, there's no guarantee the medicine will work, and it might not help you personally. There are also potential risks involved, including possible side effects from the study medicine, which will be carefully explained to you. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Spain
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Unverified
Italy

Common questions

What are lupus nephritis and IgA nephropathy?

Both are kidney diseases. Lupus nephritis happens when lupus affects the kidneys, and IgA nephropathy involves a build-up of antibodies in the kidneys, both leading to kidney damage.

What does 'protein in the urine' mean?

Healthy kidneys usually stop protein from leaving your body in your urine. If protein is found, it can be a sign that your kidneys are not working as well as they should.

What is a 'placebo'?

A placebo is a 'dummy' tablet that looks just like the real medicine but contains no active ingredient. It's used to compare the effects of the actual medicine fairly.

What is eGFR?

eGFR stands for 'estimated Glomerular Filtration Rate'. It's a calculation based on a blood test that shows how well your kidneys are filtering waste from your blood.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving the experimental medicine or the placebo. This helps ensure the study results are unbiased.