Study on Long-term Safety and Efficacy of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

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What is this study about?

This clinical trial is focused on studying the long-term safety and effectiveness of a treatment called pegcetacoplan for patients with two specific kidney diseases: C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis. These conditions affect the kidneys and can lead to problems with kidney function. The study aims to understand how well pegcetacoplan works over an extended period and to ensure it is safe for patients to use.

Participants in this study will receive pegcetacoplan, which is administered as a subcutaneous infusion, meaning it is given under the skin using a special device. The study will monitor participants over time to see how their kidney function changes and to check for any side effects. The study will also compare the results to those from before the treatment started to see if there are improvements in kidney health.

Throughout the study, participants will be regularly assessed to track their progress and any changes in their condition. The study will last for several years, allowing researchers to gather comprehensive data on the long-term effects of pegcetacoplan. This information will help determine if pegcetacoplan is a viable long-term treatment option for these kidney diseases.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and confirm your eligibility based on the criteria of the study.

A urine pregnancy test will be conducted for female participants of childbearing potential. You will also discuss and agree on the use of appropriate contraception methods for the duration of the study.

2 self-administration training

You will receive training on how to self-administer the medication pegcetacoplan, or a caregiver will be identified to assist with the administration.

The medication is administered either through an intramuscular injection or subcutaneous use.

3 medication administration

You will begin administering pegcetacoplan as instructed. The frequency and dosage will be determined by the healthcare team based on your specific needs and the study protocol.

It is important to follow the administration schedule and report any issues or side effects to the healthcare team.

4 regular follow-up visits

You will attend regular follow-up visits to monitor your health and the effects of the medication. These visits will include assessments such as blood tests and urine tests to measure the urine protein-to-creatinine ratio and other health indicators.

The healthcare team will evaluate the stability or improvement of your kidney function and other health parameters over time.

5 end of study

The study is expected to continue until July 2027. At the end of the study, a final evaluation will be conducted to assess the long-term safety and efficacy of pegcetacoplan.

You will receive guidance on any further treatment or follow-up care needed after the study concludes.

Who Can Join the Study?

Must have completed participation in Study APL2-C3G-310 through the Week 52 visit requirements.
Must have experienced clinical benefit from pegcetacoplan (a medication used in the study) while participating in the previous trial, according to the investigator’s opinion.
Must remain on a stable treatment plan for C3G or IC-MPGN as required by Study APL2-C3G-310.
Must have received vaccinations against S pneumoniae (a type of bacteria), N meningitidis (types A, C, W, Y, and B, which are types of bacteria), and H influenzae (type B, another type of bacteria) as required by Study APL2-C3G-310. Must also agree to receive any additional recommended vaccinations for people with complement deficiencies or weakened immune systems.
Female participants who can have children must have a negative urine pregnancy test at the first visit and agree to use specific methods of birth control during the study and for at least 90 days after the last dose of pegcetacoplan.
Male participants must agree to use specific methods of birth control and agree not to donate semen during the study and for at least 90 days after the last dose of pegcetacoplan.
Participants who are above the legal age of consent must be willing and able to provide informed consent. For participants under the legal age of consent, their legally authorized representative must provide informed consent, and the participants themselves must also agree to participate if appropriate.
Must be willing and able to self-administer pegcetacoplan or have a caregiver who can do it for them.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medication cannot participate.
Patients with active infections that require treatment are not eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with a history of drug or alcohol abuse within the past year cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with any other medical condition that the study doctors believe would make participation unsafe are excluded.
Patients who have had a kidney transplant are not eligible for the study.
Patients who have received certain medications that affect the immune system within the past 3 months cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Medizinische Hochschule Hannover	Hanover	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Seymiqryt Rfgzpfc Uvjkgbdlgm Mshjofn Cwzlkg	Nijmegen	The Netherlands
Byhuqnj Cpheulsswfnvmtul Hkfnmalf	Groningen	The Netherlands
Ayqxiauhq Uau	Amsterdam	The Netherlands
Aycffhw Uhixu Skbdwtvoa Lhfuby Dr Bqnxymm	Bologna	Italy
Iaazusjse Fwx Cufrftbz Abv Euxxkazjmkpv Mbdfccnq	Prague	Czechia
Hrraouep Viae dzpyjwxk	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	29.05.2023
Belgium	Not recruiting	29.05.2023
Czechia	Not recruiting	29.05.2023
France	Not recruiting	29.05.2023
Germany	Not recruiting	29.05.2023
Italy	Not recruiting	29.05.2023
Spain	Not recruiting	29.05.2023
The Netherlands	Not recruiting	29.05.2023

Trial locations

Investigated drugs:

Pegcetacoplan is a medication being studied for its long-term safety and effectiveness in treating certain kidney conditions, specifically C3 Glomerulopathy (C3G) and Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN). These conditions involve problems with the immune system that can damage the kidneys. Pegcetacoplan works by targeting a part of the immune system called the complement system, which is often overactive in these diseases. By controlling this part of the immune system, pegcetacoplan aims to reduce kidney damage and improve kidney function over time.

Investigated diseases:

C3 glomerulopathy

C3 glomerulopathy (C3G) – C3 glomerulopathy is a kidney disease characterized by the abnormal accumulation of complement protein C3 in the glomeruli, which are the filtering units of the kidney. This accumulation leads to inflammation and damage to the glomeruli, affecting their ability to filter waste from the blood. Over time, this can result in proteinuria, where excess protein is found in the urine, and a decline in kidney function. The disease progresses with varying degrees of severity, and symptoms may include blood in the urine, swelling, and high blood pressure. The exact cause of C3G is not fully understood, but it involves dysregulation of the complement system, a part of the immune system. Monitoring kidney function and protein levels in the urine is crucial in understanding the progression of the disease.

Immune complex membranoproliferative glomerulonephritis (IC-MPGN) – Immune complex membranoproliferative glomerulonephritis is a kidney disorder where immune complexes, which are clusters of antibodies and antigens, deposit in the glomeruli. This deposition leads to inflammation and thickening of the glomerular basement membrane, disrupting normal kidney function. As the disease progresses, it can cause proteinuria, hematuria (blood in urine), and reduced kidney function. The condition may also lead to swelling in various parts of the body due to fluid retention. IC-MPGN is often associated with infections, autoimmune diseases, or other conditions that cause chronic immune activation. The progression of the disease can vary, and regular monitoring of kidney function is important.

Trial ID:

2023-504625-39-00

Protocol code:

APL2-C3G-314

NCT ID:

NCT05809531

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Safety and Efficacy of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

What is this study about?

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