Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

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What is this study about?

The study focuses on two rare kidney disorders: C3 Glomerulopathy and Primary Immune Complex Membranoproliferative Glomerulonephritis. Both conditions affect the tiny filtering units in the kidneys, leading to excess protein leaking into the urine and a gradual loss of kidney function. The medication being examined is a specially formulated solution called pegcetacoplan, which is given as a subcutaneous (under‑the‑skin) injection. This drug works by targeting a part of the immune system that can cause inflammation and damage in these diseases.

The purpose of the study is to describe how well pegcetacoplan works in everyday medical practice and to assess its safety. Participants who are already receiving the medication will be followed for several years, with regular visits at roughly one, three, six, and twelve months after starting treatment and then every six months thereafter. During these visits doctors will check the amount of protein in the urine using a test called UPCR (a measurement of protein‑to‑creatinine ratio) and will evaluate kidney filtering ability with the eGFR test, which estimates how efficiently the kidneys are cleaning the blood. Simple questionnaires may also be used to capture how patients feel and how the disease affects daily life.

In addition to the main health checks, information such as age, sex, other medicines being taken, and any side effects will be recorded. Safety monitoring includes watching for serious infections, significant drops in kidney function, and the need for procedures like dialysis or a kidney transplant. The collected data will help doctors understand the overall benefit‑risk profile of the drug for people living with these rare kidney conditions.

1 enrollment in the study

after providing informed consent, you receive a study identification number.

your demographic information (age, sex, race) and medical history are recorded.

2 baseline assessments

clinical characteristics of your kidney disease are measured, including blood tests for serum creatinine and calculation of eGFR (estimated glomerular filtration rate).

protein in the urine is measured and expressed as the urine protein‑to‑creatinine ratio (UPCR).

a kidney biopsy may be performed to evaluate disease activity and complement component C3c staining.

any prior or current treatments for c3g or ic‑mpgn are documented.

3 initiation of pegcetacoplan therapy

you begin receiving pegcetacoplan as a 308.6 mg subcutaneous injection (solution for infusion).

the medication is administered at regular intervals as directed by your physician; the exact schedule is individualized.

treatment continues for the duration of the study unless a dose change, switch, or discontinuation is required.

4 regular follow‑up visits

follow‑up visits are scheduled at 1 month, 3 months, 6 months, 12 months, and then every 6 months.

at each visit, the following are performed:

– measurement of UPCR to assess proteinuria, aiming for a value of less than 1 g/g.

– repeat blood tests to calculate eGFR and monitor other laboratory parameters.

– assessment of safety, including monitoring for serious infections, malignancies, and acute kidney injury.

– completion of patient‑reported outcome questionnaires such as the FACIT‑Fatigue and WPAI scales.

5 monitoring of treatment outcomes

the study tracks whether you achieve a reduction of at least 50 % in proteinuria and whether UPCR falls below thresholds of 1 g/g, 0.5 g/g (adults), or 0.2 g/g (children).

changes in kidney function (eGFR) are recorded at each visit to detect sustained doubling of serum creatinine or progression to end‑stage kidney disease.

any new need for dialysis, kidney transplant, or death related to kidney failure is documented.

6 dose adjustments and treatment modifications

if your physician determines a dose change is necessary, the new dose and reason are recorded in the study database.

should you switch from pegcetacoplan to another complement inhibitor such as iptacopan, additional assessments are performed at 2 weeks, 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter.

7 assessment after treatment change or discontinuation

if pegcetacoplan is discontinued or restarted, the same laboratory and clinical evaluations are repeated at the same intervals as during continuous therapy.

biomarker levels, kidney biopsy findings, and patient‑reported outcomes are compared to the most recent measurements before the change.

8 study completion

the study concludes on the estimated end date of 30 june 2032 or when you stop treatment, whichever occurs first.

final assessments include the last set of laboratory tests, UPCR and eGFR measurements, and completion of the outcome questionnaires.

Who Can Join the Study?

  • You have been diagnosed with either Primary Immune Complex Membranoproliferative Glomerulonephritis (a rare kidney disease) or C3 Glomerulopathy (another rare kidney disease that affects the kidney’s filtering system).
  • You are already receiving, or you plan to receive, the medication pegcetacoplan as a treatment for one of these kidney diseases.
  • You can give a signed and dated informed consent form. If you are under the legal age, a parent or legal guardian must sign the consent, and you will also give your agreement (called assent) as required.
  • You may be any gender (male or female).
  • You may be in any of the approved age groups, including children, teenagers, or adults.
  • Participation is allowed for people who are considered vulnerable (for example, children or others who need extra protection).

Who Cannot Join the Study?

  • If you are currently taking a test drug (an investigational treatment) for C3G or primary IC‑MPGN, you cannot join this study. An investigational treatment is a medication that is still being studied and not yet approved for regular use.
  • If you have already started using pegcetacoplan as part of another research project (an interventional study), you cannot participate. An interventional study is a trial where participants receive a specific medical intervention being tested.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
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
Foch Hôpital Suresnes France
CHU Lille Lille France
Hospital Henri Mondor Creteil France
Cur Rfmhu – Huvkqhl Mubzhz Bprofya Reims France
Hozigsvs Vtxg dragplnd Barcelona Spain
Htnxtjso Uephauzdlpenl di A Ckxtpj A Coruna Galicia Spain
Ufuykevyhokjolarldodx Esgsq Akr Essen Germany
Fnetznlps Pvys Ls Imuosgbcwizhj Bpdwfvuni Dde Hehkjehl Ummwnypvydrun Lf Pcs Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated drugs:

pegcetacoplan is a medication given as a subcutaneous infusion. It works by blocking a part of the immune system called complement component C3. By inhibiting C3, the drug helps reduce inflammation and damage in the kidneys caused by C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis. In this study, participants receive pegcetacoplan to see how well it controls their disease and to monitor its safety when used in everyday medical practice.

Investigated diseases:

Primary Immune Complex Membranoproliferative Glomerulonephritis – It is a rare kidney disorder where immune complexes deposit in the filtering units, causing inflammation and thickening of the walls. Over time the inflammation can lead to swelling, scarring, and reduced ability to filter waste. It often results in excess protein leaking into the urine. The condition may progress slowly, with gradual changes in kidney function. Patients may notice swelling in the legs or ankles as fluid builds up.
C3 Glomerulopathy – It is a rare kidney disease caused by abnormal activation of a part of the immune system called complement, leading to buildup of a protein called C3 in the kidney filters. The buildup triggers inflammation and damage to the tiny blood vessels that clean the blood. Over months or years this damage can cause protein to appear in the urine and may reduce the kidney’s filtering capacity. The disease often advances gradually, with increasing signs of fluid retention or swelling. Ongoing changes in kidney function can be monitored by measuring waste products in the blood.

Trial ID:
2025-524487-37-00
Protocol code:
Sobi.PEGCET-402
Trial Phase:
Therapeutic confirmatory (Phase III)

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