Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

This research study is looking into a new medicine called Pegcetacoplan for two specific kidney conditions: C3 Glomerulopathy and Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN). Both conditions can cause the kidneys to not work as well as they should. The study aims to find out if Pegcetacoplan is effective and safe in treating these conditions. Participants will receive either the new medicine or a dummy treatment (placebo). Researchers will be carefully monitoring changes in protein levels in the urine, how well the kidneys are working, and overall well-being. This is a Phase 3 study, meaning it's a large, important step in determining if this medicine could become a widely available treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Apellis Pharmaceuticals Inc.

Enrolment target

Start

08 Nov 2024

complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)

What is this study about?

This study is investigating a new medication called Pegcetacoplan for people living with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis, often shortened to IC-MPGN. These are both rare kidney diseases where parts of the kidney become inflamed and damaged over time, which can lead to the kidneys not working properly. We know that dealing with kidney disease can be challenging, and researchers are always looking for better ways to manage these conditions and improve quality of life.

The main goal of this particular study is to see if Pegcetacoplan can help reduce the amount of protein in the urine. Having too much protein in the urine is a common sign of kidney damage, and reducing it is often a good indicator that the kidneys are getting healthier. The study will also look at how well the kidneys are working overall, if there are changes in kidney tissue seen in biopsies, and how participants feel in terms of their energy levels and general health.

To make sure the results are as clear and reliable as possible, the study is comparing Pegcetacoplan to a 'placebo.' A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. Neither you nor your doctor will know whether you are receiving the active medicine or the placebo – this is called 'double-blinded' – which helps prevent any bias in the results. This approach helps researchers fairly assess the true effects of the new medicine.

Key takeaways

This study is for adults with C3 Glomerulopathy or IC-MPGN.
It's testing a new medicine called Pegcetacoplan against a dummy treatment (placebo).
The main goal is to improve kidney function and reduce protein in the urine.
Participation involves regular clinic visits, tests, and potentially kidney biopsies.
You won't know if you're getting the medicine or placebo.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over. Both men and women are welcome to take part.

To be considered for the study, you must have a confirmed diagnosis of either C3 Glomerulopathy or IC-MPGN. There will be other specific medical checks and tests that the study team will carry out to make sure the study is suitable for you and that you meet all the necessary health requirements.

It's important to remember that not everyone with these conditions will be able to join the study, as there are strict guidelines. If you are interested, the study team will be able to explain these to you in a way that makes sense and answer any questions you have about your individual situation.

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?
Do you have a diagnosis of C3 Glomerulopathy (C3G)?
Do you have a diagnosis of Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)?
Are you able to attend regular clinic visits and have medical tests?
Are you willing to potentially receive a placebo (dummy treatment)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive either the new medicine (Pegcetacoplan) or a placebo (a dummy treatment) through an infusion, which means it will be given directly into your vein. You won't know which one you're receiving, and neither will your doctor.

Over the course of the study, you will have several visits to the clinic. At these visits, the study team will perform various assessments. These will include blood tests, urine tests to measure protein levels, and checks on how well your kidneys are working. Some participants might also have kidney biopsies, which involve taking a small tissue sample from your kidney for examination. You'll also be asked to complete questionnaires about your fatigue and general quality of life to see how you are feeling.

The study will last for a set period, and after the initial treatment phase, there will be follow-up appointments to monitor your health. The study team will explain the exact schedule of visits and procedures, as well as the total duration you would be involved.

Potential risks and benefits

Taking part in a clinical study means you could potentially benefit from a new treatment that isn't widely available yet, and you'll receive close medical monitoring. However, there are no guarantees that the new medicine will help you, and it might have side effects, just like any medication. The placebo, on the other hand, is generally harmless but offers no medical benefit. The study team will explain all known potential risks and side effects to you in detail. You are always in control of your participation and have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Austria
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Unverified
Netherlands
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Unverified
Italy
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Unverified
Germany

Common questions

What are C3 Glomerulopathy and IC-MPGN?

They are rare kidney diseases where parts of your kidneys become inflamed and damaged over time, affecting how well your kidneys work.

What is Pegcetacoplan?

It's a new medicine being tested in this study to see if it can help reduce kidney damage and improve kidney function in people with these conditions.

What does 'placebo-controlled' mean?

It means some participants will receive the new medicine and others will get a dummy treatment that looks the same but has no active ingredients. This helps researchers compare the effects fairly.

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

No, neither you nor your doctor will know, as this is a 'double-blinded' study. This is to ensure the results are not biased.

What are the main things the researchers are looking for?

They are mainly looking to see if the medicine can reduce protein in your urine and improve how well your kidneys are working.