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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment

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

  2. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

2 criteria

  • 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).
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Investigated drugs

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.

What is already known about the treatment

ASPAVELI 1080 mg solution for infusion - ASPAVELI is given as a subcutaneous injection of a clear liquid solution. It is an orphan‑drug that has been approved in several countries for complement‑mediated blood disorders and is being studied for rare kidney diseases such as C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis. The medicine works by attaching to the complement protein C3, stopping the protein from starting the immune cascade that can damage tissues. It belongs to the class of complement C3 inhibitors, a type of immunomodulating drug.

Investigated diseases

  • 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524487-37-00Protocol codeSobi.PEGCET-402Estimated enrolment145 patientsSponsorSwedish Orphan Biovitrum AB (publ)

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