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RecruitingPHASE4INTERVENTIONAL

Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study

This important study is looking into a medicine called pegcetacoplan, which is used to treat two rare kidney conditions: C3 Glomerulopathy (C3G) and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN). Researchers want to understand how effective and safe this medicine is for patients in real-life situations, outside of a strict clinical trial setting. They will gather information about patients before, during, and after they start taking pegcetacoplan. This includes looking at special markers in the body that aren't usually checked. The goal is to get a clearer picture of the medicine's benefits and any potential risks for a wide range of patients, helping doctors make the best treatment choices for people with these kidney diseases.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Swedish Orphan Biovitrum
Enrolment target
150
Start
09 Jul 2026
Estimated completion
31 Jan 2032

What is this study about?

This study is all about understanding how a medicine called pegcetacoplan works for people living with two rare kidney conditions: C3 Glomerulopathy (C3G) and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN). These conditions can cause serious damage to the kidneys.

Doctors and researchers want to see how pegcetacoplan helps patients in their everyday lives, not just in a controlled study environment. They will collect information about patients who are already taking or are about to start taking pegcetacoplan. This includes looking at how their health changes over time and if the medicine has any side effects. They will also investigate certain body markers that could give more clues about the diseases and how the treatment is working.

The main aim is to build up a complete picture of the benefits and any possible risks of pegcetacoplan for a wide variety of patients. This will help doctors across the UK make informed decisions and give the best possible care to people with C3G or IC-MPGN, leading to better ways to manage these conditions.

Key takeaways

  • This study looks at a kidney medicine called pegcetacoplan in real-life situations.
  • It aims to understand how safe and effective pegcetacoplan is for people with rare kidney diseases (C3G, IC-MPGN).
  • It's an 'observational' study, meaning it gathers information from your regular medical care.
  • No new treatments or extra clinic visits are involved specifically for this study.
  • The results will help doctors make better decisions about treating these conditions.
  • Anyone receiving or planning to receive pegcetacoplan for C3G or IC-MPGN may be eligible.

Who may be eligible?

To join this study, you must either already be taking pegcetacoplan for your C3 Glomerulopathy (C3G) or Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), or be planning to start this medicine soon. You'll also need to sign a consent form, which means you understand what the study involves and agree to take part.

If you are under 18, a parent or legal guardian will need to sign the consent form for you. Depending on local rules, children and teenagers might also be asked to give their own agreement.

You cannot join this study if you are currently trying out another new medicine for C3G or IC-MPGN, or if you started pegcetacoplan as part of a different type of research study.

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.

  1. Are you taking pegcetacoplan for C3G or IC-MPGN, or planning to start it?
  2. Are you willing to sign a consent form to allow your health information to be used?
  3. Are you NOT currently taking another new, experimental drug for your kidney condition?
  4. Did you NOT start pegcetacoplan as part of a different research study where you were given the drug by the researchers?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will gather information about your health before you started pegcetacoplan, during your treatment, and after. This typically involves collecting routine medical information from your doctor's visits, such as blood test results and how you're feeling. They may also look at special markers in your body. There won't be any extra visits or new medications given specifically for this study; it's about observing your treatment as usual. The total duration of your participation will depend on how long your doctor plans for you to be on pegcetacoplan and how long your health records are followed by the study.

Potential risks and benefits

A potential benefit of taking part is that the information gathered from your experience will help doctors understand more about C3G and IC-MPGN and how best to use pegcetacoplan. This could improve care for many patients in the future. As this study observes your routine care, there are no additional risks beyond those usually associated with your ongoing medical treatment with pegcetacoplan. You have the right to withdraw from the study at any time without it affecting your medical care.

Locations (101)

  • Nepean Hospital
    Verified postcode
    Kingswood, Australia· Not yet recruiting
  • Princess Alexandra Hospital
    Verified postcode
    Woolloongabba, Australia· Not yet recruiting
  • Medizinische Universität Graz
    Verified postcode
    Graz, Austria· Not yet recruiting
  • Uniklinik Innsbruck
    Verified postcode
    Innsbruck, Austria· Not yet recruiting
  • Allgemeines Krankenhaus Wien Universitätsklinik
    Verified postcode
    Vienna, Austria· Not yet recruiting
  • Klinik Ottakring
    Verified postcode
    Vienna, Austria· Not yet recruiting
  • Cliniques Universitaires Saint-Luc
    Verified postcode
    Brussels, Belgium· Not yet recruiting
  • University hosptial of Antwerpen
    Verified postcode
    Edegem, Belgium· Not yet recruiting
  • Grand Hôpital de Charleroi
    Verified postcode
    Gilly, Belgium· Not yet recruiting
  • UZ Leuven
    Verified postcode
    Leuven, Belgium· Not yet recruiting
  • Centre Hospitalier Universitaire de Liege
    Verified postcode
    Liège, Belgium· Not yet recruiting
  • CHU UCL Namur
    Verified postcode
    Namur, Belgium· Not yet recruiting

Common questions

What are C3G and IC-MPGN?

These are rare kidney diseases that can damage the filters in your kidneys and affect how they work.

What is pegcetacoplan?

Pegcetacoplan is a medicine used to treat C3G and IC-MPGN by helping to control part of the body's immune system.

Will I receive a new treatment in this study?

No, this study observes how pegcetacoplan works for you as part of your regular treatment; no new treatments are given.

How long will I be in the study?

Your involvement will depend on how long you are treated with pegcetacoplan and the duration your health information is collected for analysis.

Is my personal information kept private?

Yes, all your personal and health information will be kept confidential and used only for research purposes, protecting your privacy.

How to find out more

Study Physician

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

Interested in taking part?

Register your interest

Share your details and the research team for "Real-World Effectiveness and Safety of Pegcetacoplan in Pati…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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