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Pegcetacoplan to Prevent Recurrence of C3 Glomerulopathy or Primary Immune‑Complex MPGN in Adolescent and Adult Kidney Transplant Recipients

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study involves individuals who have been diagnosed with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis and are planning to receive a kidney transplant. These rare kidney conditions can cause the transplanted kidney to become damaged again after the surgery. The medication being examined is pegcetacoplan, which is given by a subcutaneous infusion.

The purpose of the study is to determine whether pegcetacoplan can safely prevent the disease from returning after transplantation. Participants will receive the medication regularly for up to two years, and their kidney health will be checked through routine blood and urine tests as well as occasional biopsy procedures, where a tiny piece of kidney tissue is examined under a microscope. Tests include the urinary protein-to-creatinine ratio, which shows how much protein is leaking into the urine, and the estimated glomerular filtration rate, which estimates how well the kidneys are filtering waste. The presence of hematuria (blood in the urine) will also be monitored. Any serious side effects that occur during the study will be recorded.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First Dose Administration

    You will receive the first dose of pegcetacoplan at a strength of 1080 mg. The medication is given as a subcutaneous infusion, which means it is delivered under the skin using a small needle. This initial dose marks the start of your participation in the study.

  2. Step 2

    Ongoing Medication Schedule

    You will continue to receive pegcetacoplan at the same dose of 1080 mg for the entire study period, which lasts for two years. The medication will be administered according to the schedule set by the study team, and each dose will be given by subcutaneous infusion.

  3. Step 3

    Regular Clinic Visits for Safety Checks

    You will attend clinic visits at regular intervals throughout the two‑year study. During each visit, staff will perform safety checks, which include blood tests and urine tests. These tests help monitor the function of your transplanted kidney and detect any early signs of disease recurrence.

  4. Step 4

    Scheduled Kidney Biopsies

    At predetermined times, you will undergo a kidney biopsy. This procedure involves taking a small sample of kidney tissue to look for signs of disease returning. The biopsy results, together with your lab tests, are used to determine whether the disease has recurred.

  5. Step 5

    Reporting Side Effects

    You should inform the study team of any new symptoms, side effects, or health changes you experience. Prompt reporting helps the team assess safety and manage any adverse events.

  6. Step 6

    Continuation Until Study Completion

    You will keep taking pegcetacoplan and attending all scheduled visits for the full two‑year duration of the study, unless advised otherwise by the investigator.

  7. Step 7

    Final Assessment

    At the end of the two‑year period, you will have a final assessment that may include a last kidney biopsy, final laboratory tests, and an overall evaluation of your health status. This assessment helps determine the overall effectiveness and safety of the medication.

Who can join the trial?

4 criteria

  • Be a male or female who has been diagnosed with C3G (a rare kidney disease) or primary IC‑MPGN (another rare kidney disease) and is planning to have a kidney transplantation because of this condition.
  • Be at least 12 years old when you give your informed consent (or assent if you are under 18), meaning you understand the study and agree to take part.
  • Have a high chance that the disease could come back after the kidney transplant. This can be shown by having lost a previous transplanted kidney because the disease returned, or your doctor believes the risk is high based on other health information.
  • Be fully vaccinated and up to date with the vaccines for Streptococcus pneumoniae (bacteria that can cause pneumonia), Neisseria meningitidis (bacteria that can cause meningitis), and Haemophilus influenzae B (bacteria that can cause serious infections), according to local guidelines.

Who cannot join the trial?

2 criteria

  • Having a known secondary cause for the kidney disease, such as monoclonal gammopathy of clinical significance (a problem with a specific type of blood protein), hepatitis B or hepatitis C (viral infections of the liver), or autoimmune cryoglobulinemia (an immune system disorder that creates abnormal proteins that can damage blood vessels).
  • Having used a complement inhibitor (a medicine that blocks a part of the immune system called the complement pathway) to treat C3G or primary IC-MPGN within one month before the planned kidney transplant surgery.
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Investigated drugs

Pegcetacoplan is a specially designed medicine that works by blocking a part of the immune system called the complement system, specifically the protein C3. In this study, it is given to people who have had a kidney transplant because they have a condition called C3 glomerulopathy or primary immune‑complex membranoproliferative glomerulonephritis. The goal is to see if pegcetacoplan can help keep the disease from coming back in the new kidney, which could improve the long‑term success of the transplant.

What is already known about the treatment

Pegcetacoplan - This medication is given as a subcutaneous injection of a liquid solution for infusion, with each dose containing 1080 mg of the drug. It is an orphan‑drug that has been approved in several countries for complement‑mediated kidney diseases and is being studied in clinical trials for transplant patients. The main use is to help prevent the return of C3 glomerulopathy or primary immune‑complex membranoproliferative glomerulonephritis after a kidney transplant. Pegcetacoplan works by binding to the protein C3 in the blood, stopping the complement system from becoming over‑active, and it is classified as a complement C3 inhibitor.

Investigated diseases

  • C3 glomerulopathy

    It is a rare kidney disorder in which the complement protein C3 builds up in the glomeruli, the tiny filtering units of the kidney, causing inflammation. This leads to swelling, blood and protein in the urine, and a gradual loss of kidney function. The disease can start at any age and often progresses slowly, but periods of faster decline may occur. After a kidney transplant, the same pattern of C3 deposition can reappear in the new organ.

  • Immune complex‑mediated membranoproliferative glomerulonephritis

    This condition is characterized by the accumulation of immune complexes in the kidney’s glomeruli, producing thickened capillary walls and increased cell growth. It causes proteinuria, hematuria, and a steady reduction in the kidney’s filtration ability. The illness typically advances over several years and may worsen during infections or other immune system activations. When a patient receives a kidney transplant, the immune complex process can recur and affect the transplanted kidney.

Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526392-39-00Protocol codeSobi.PEGCET-404Estimated enrolment25 patientsSponsorSwedish Orphan Biovitrum AB (publ)

sourced from the EU Clinical Trials Register and site verification

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