Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative Glomerulonephritis

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What is this study about?

The study looks at two very rare kidney diseases, C3 Glomerulopathy (C3G) and Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), and evaluates the medication pegcetacoplan, which is given as a subcutaneous infusion. The purpose of the study is to evaluate how well pegcetacoplan works and how safe it is in people with these conditions.

Participants will receive regular doses of the medication and will be followed for many months with visits to check their health. During these visits doctors will measure the amount of protein in the urine, known as proteinuria (a sign that the kidneys are leaking protein), and will calculate the eGFR, a test that estimates how well the kidneys are filtering blood. Other checks include blood tests, imaging, and sometimes a small kidney tissue sample called a biopsy to see how the disease is responding. The study will also record if any serious kidney problems occur, such as a need for dialysis (a machine that cleans the blood when kidneys can’t), a kidney transplant, or a rapid rise in a waste product called serum creatinine. All information will be collected over time to understand the medication’s benefits and any side effects.

1 initial enrollment

after joining the study baseline information is recorded, including age, sex, race and details of the kidney disease.

2 start of medication

you begin receiving aspaveli (pegcetacoplan) as a subcutaneous infusion.

each dose contains 308.6 mg of the active substance.

the dosing schedule follows the study protocol and continues for the entire observation period.

3 first month assessment

at 1 month after starting treatment a urine test is performed to measure protein excretion (UPCR).

blood is drawn to calculate kidney function (eGFR) and to check other laboratory values.

questionnaires about fatigue (FACIT‑Fatigue) and work productivity (WPAI) are completed.

4 third month assessment

at 3 months the same urine and blood tests are repeated.

any changes in medication dose or side effects are recorded.

5 six month assessment

at 6 months a urine protein test (UPCR) is done to see if it is below 1 g/g, the primary goal of the study.

blood work for eGFR and other labs is repeated.

questionnaires on fatigue and work productivity are filled out again.

the occurrence of a ≥50 % reduction in proteinuria and other clinical outcomes such as kidney function decline are evaluated.

6 twelve month assessment

at 12 months urine protein, blood kidney function and laboratory parameters are measured again.

additional questionnaires are completed.

any serious infections, malignancies or acute kidney injury are documented.

7 ongoing six‑month follow‑up

after the first year, assessments are repeated every 6 months.

each visit includes urine protein (UPCR), blood kidney function (eGFR), safety monitoring and the patient‑reported outcome questionnaires.

8 annual follow‑up

once a year a comprehensive review is performed, including laboratory tests, kidney biopsy findings if indicated, and evaluation of long‑term safety such as hospital admissions and dialysis need.

9 treatment discontinuation or change

if the medication is stopped, restarted or switched to another complement inhibitor, additional measurements are taken at 2 weeks, 1, 3, 6 and 12 months after the change.

10 study completion

the study ends when the scheduled observation period finishes, after which final data on proteinuria, kidney function, safety events and patient‑reported outcomes are compiled.

Who Can Join the Study?

Be willing to receive or already be receiving pegcetacoplan, a medication used to treat C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC‑MPGN). (These are rare kidney diseases where the immune system damages the filtering units.)
Give a signed and dated informed consent form. This means you agree to join the study after understanding what will happen. If you are under the legal age, a parent or legal guardian must sign, and you may also be asked to give your agreement (called assent).
Be a patient with one of the listed kidney conditions, not a healthy volunteer.
Be of any gender (male or female).
Be part of a group that may be considered vulnerable, such as children, adolescents, or adults who need extra protection, and be able to follow study requirements.
Be within the age ranges allowed by the study, which include children, teenagers, and adults.

Who Cannot Join the Study?

You are already taking a investigational treatment (a drug that is still being tested and not yet approved) for C3G or primary IC‑MPGN when you would start the study drug pegcetacoplan.
You have already begun using pegcetacoplan as part of another research project called an interventional study (a study where participants receive a specific treatment that is being evaluated).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hôpital Européen Georges-Pompidou	Paris	France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Robert Debre University Hospital	Paris	France
Robert Bosch Gesellschaft fuer medizinische Forschung mbH	Stuttgart	Germany
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Klinik und Poliklinik für Kinder und Jugendmedizin der Universität zu Koeln	Cologne	Germany
Hopital de la Conception	Marseille	France
Medical School Hannover	Hanover	Germany
Heidelberg University Hospital	Heidelberg	Germany
Nephrology Center Villingen‑Schwenningen	Villingen-Schwenningen	Germany
Hôpital Necker – Enfants Malades	Paris	France
CHU de Bordeaux, Hôpital Pellegrin	Bordeaux	France
CHU Lille	Lille	France
Hospital Henri Mondor	Creteil	France
Cfa Rsuol – Hjiomdt Mdwpgx Blrwlyp	Reims	France
Hyrkdbuy Viem dhcruxjx	Barcelona	Spain
Hnhupdgp Utfvsinfhrhsa dz A Chpudc	A Coruna Galicia	Spain
Uxheojgkhdevqcnwaesrc Etarg Asv	Essen	Germany
Faymbppcg Pnpt Lg Izpuhlqhwzjoh Bzamrmoef Dkp Hdqsthhq Uqzokbsoydwyr Lb Pdh	Madrid	Spain

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	30.09.2026
Germany	Recruiting	30.09.2026
Italy	Not yet recruiting	30.09.2026
Spain	Recruiting	30.09.2026

Trial locations

Investigated drugs:

Pegcetacoplan

pegcetacoplan is a medication given as a subcutaneous infusion that works by blocking a part of the immune system called complement component C3. By doing this, it helps reduce the inflammation and damage that can occur in the kidneys of people with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC‑MPGN). In this study, the drug is being used to see how well it works and how safe it is when used in everyday medical practice.

Investigated diseases:

Glomerulonephritis membranoproliferative

Primary immune complex membranoproliferative glomerulonephritis (IC‑MPGN) – This is a rare kidney disorder where immune complexes deposit in the glomeruli, causing inflammation and thickening of the capillary walls. Over time, the affected glomeruli become scarred, leading to gradual loss of filtering ability. Patients often develop increasing amounts of protein in the urine as the disease progresses. The condition can cause the kidneys to work less efficiently, reflected by a slow decline in kidney function tests. Persistent inflammation may result in swelling of the kidneys and changes in blood pressure. The disease typically follows a slow, chronic course with periods of worsening protein loss.

C3 glomerulopathy (C3G) – This is a rare kidney disease characterized by abnormal activation of the complement system, leading to deposition of the C3 protein in the glomeruli. The deposited C3 triggers inflammation that damages the tiny filtering units of the kidney. As the disease advances, more protein leaks into the urine and the kidneys filter blood less effectively. Over months to years, the ongoing injury can cause a steady decline in kidney function. Some patients experience swelling and changes in urine appearance as the condition worsens. The progression is usually gradual, with periods of stable function alternating with episodes of increased protein loss.

Trial ID:

2025-524487-37-00

Protocol code:

Sobi.PEGCET-402

Trial Phase:

Therapeutic confirmatory (Phase III)

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Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative Glomerulonephritis

What is this study about?

Who Can Join the Study?

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