Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy

This research study is looking into a new treatment called sibeprenlimab for adults who have a kidney disease called IgA nephropathy. In this condition, the kidneys don't work as well as they should. The main goal is to find out if sibeprenlimab can reduce the amount of protein in your urine after 9 months, which is a sign of kidney damage. The study will also track how well your kidneys work over about two years and check for any side effects of the new medicine. Half the participants will get the new medicine, and the other half will get a dummy medicine (placebo), so researchers can compare the results fairly.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Otsuka Pharmaceutical Development And Commercialization Inc.

Enrolment target

Start

31 Aug 2022

IgA Nephropathy

What is this study about?

This study is designed to carefully look at a new medicine called sibeprenlimab for people living with a kidney condition called IgA nephropathy. This condition happens when a type of antibody, called IgA, builds up in the filters of your kidneys, causing damage and making it harder for your kidneys to do their job properly. Over time, this can lead to serious kidney problems.

Researchers want to see if Sibeprenlimab can help slow down or stop this damage. They will be comparing it to a "dummy" medicine (placebo) to make sure any improvements are truly due to Sibeprenlimab. This kind of study helps us understand if new treatments are both effective and safe for people who need them.

The main thing the doctors will be watching is how much protein is in your urine, as this is a key sign of kidney health in IgA nephropathy. They'll also be tracking how well your kidneys are working over a longer period, which is very important for people with this condition. Understanding these effects will help determine if sibeprenlimab could be a new option to help people manage IgA nephropathy.

Key takeaways

Tests a new medicine (sibeprenlimab) for IgA nephropathy.
Compares it to a dummy medicine (placebo) to see if it helps.
Aims to reduce protein in urine and improve kidney function.
Involves regular clinic visits over about two years.
Participants are adults (18+), male or female.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to everyone, regardless of whether you are male or female.

Beyond these basic requirements, doctors will carefully check your medical history and current health to make sure the study is a safe and suitable option for you. This will include specific tests related to your IgA nephropathy condition to ensure you meet the criteria for the study.

There might be other health conditions or medications that would prevent someone from joining, so it's important to discuss everything openly with the study team.

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 IgA nephropathy?
Are you able to attend regular clinic visits for about two years?
Are you open to the possibility of receiving either the new medicine or a dummy treatment?
Are you able to provide regular urine and blood samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new medicine, sibeprenlimab, or a dummy medicine (placebo), given as an injection under the skin. You won't know which one you're getting, and neither will the study doctors, to make the results as fair as possible. You'll have regular visits to the clinic over a period of about two years.

During these visits, doctors will collect urine samples over 24 hours to check for protein, take blood samples to measure different markers including your kidney function and how your body reacts to the medicine, and conduct physical exams. They will also check your heart with an ECG and monitor for any side effects. The total duration of your active participation, including follow-up, will be around 24 months or more.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new medicine that could improve your kidney health if the medicine works as expected. You would also be contributing important information to medical science, which could help future patients with IgA nephropathy. However, there are potential risks, as with any new medicine. You might experience side effects from sibeprenlimab, or from the injections. There's also a chance you could receive the dummy medicine and not get any direct benefit from the new treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

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

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Unverified
Croatia
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Unverified
Spain
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Unverified
Greece
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Unverified
Italy
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Unverified
Czechia
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Unverified
France
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Unverified
Belgium
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Unverified
Germany
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Unverified
Hungary
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Unverified
Poland
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Unverified
Netherlands
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Unverified
Portugal

Common questions

What is IgA nephropathy?

IgA nephropathy is a kidney disease where a type of protein, called IgA, builds up in your kidneys, damaging them and making them less able to filter waste from your blood.

What is a 'Phase 3' study?

A Phase 3 study means the new medicine has already been tested in smaller groups of people and looks promising. This phase tests it in a larger group to confirm it works and is safe before it can be made widely available.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the new medicine's effects accurately.

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

No, neither you nor your study doctors will know if you're receiving the medicine or the placebo during the study. This is called 'double-blind' and helps ensure fair and unbiased results.

What does 'uPCR' mean?

uPCR stands for 'urine protein to creatinine ratio'. It's a way doctors measure how much protein is leaking into your urine, which can show how well your kidneys are working.