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Study on the Effectiveness and Safety 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 two kidney diseases: Complement 3 Glomerulopathy (C3G) and Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN). These are conditions where the immune system affects the kidneys, leading to problems with kidney function. The study is testing a treatment called Pegcetacoplan, which is given as a solution for infusion. This means the medication is delivered directly into the body through a needle. The study also involves a placebo, which is a substance with no active medication, to compare the effects of Pegcetacoplan.

The purpose of the study is to evaluate how effective and safe Pegcetacoplan is for patients with C3G or IC-MPGN. Participants in the study will receive the treatment twice a week. The study will last for a period of time, during which participants will be monitored to see if there is a reduction in proteinuria, which is the presence of excess protein in the urine and a sign of kidney damage. The study aims to see if Pegcetacoplan can help reduce this proteinuria and improve kidney function.

Throughout the study, participants will receive regular check-ups to monitor their health and the effects of the treatment. The study is designed to be double-blinded, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results. The study will help determine if Pegcetacoplan can be a beneficial treatment option for those suffering from these specific kidney diseases.

1 randomization

Participants are randomly assigned to receive either the study medication or a placebo. This process is double-blinded, meaning neither the participants nor the researchers know who receives the actual medication.

2 medication administration

The study involves the administration of pegcetacoplan, a medication given as a subcutaneous infusion. This means it is injected under the skin.

The dosage is 1,080 mg of pegcetacoplan, administered twice a week. Participants or their caregivers must be willing and able to perform these injections.

3 treatment duration

The treatment period lasts for 26 weeks. During this time, participants continue to receive their assigned treatment and attend regular study visits for monitoring.

4 monitoring and assessments

Throughout the study, participants undergo various assessments to monitor their health and the effects of the treatment. This includes regular blood tests, urine tests, and possibly kidney biopsies.

The primary focus is on measuring changes in proteinuria (protein levels in urine) and kidney function.

5 end of treatment evaluation

At the end of the 26-week treatment period, participants undergo a final evaluation to assess the overall impact of the treatment on their condition.

This includes a comparison of kidney function and proteinuria levels from the start of the study to the end.

Who Can Join the Study?

  • Must be at least 18 years old. Adolescents aged 12-17 years who weigh at least 30 kg can also join.
  • Men must agree to use specific birth control methods and not donate semen from the start of the study until 90 days after the last dose of the study drug.
  • Participants who are old enough to give legal consent must agree to participate. If under the legal age, a legal representative must agree, and the participant should also agree if possible.
  • Must be willing and able to give themselves the study drug or have someone who can do it for them.
  • Must have a diagnosis of primary C3G or IC-MPGN, which are specific kidney conditions, with or without a previous kidney transplant.
  • Must show signs of active kidney disease, proven by certain tests like a kidney biopsy or blood and urine tests.
  • For adults or adolescents who provide a kidney biopsy, no more than 50% of the kidney tissue should show certain types of damage.
  • Must have a certain level of protein in the urine, measured during a 24-hour urine collection and other urine tests.
  • Must have a certain level of kidney function, measured by a test called eGFR.
  • Must be on a stable treatment plan for their kidney condition for at least 12 weeks before starting the study. This includes certain medications that help manage the condition.
  • Must have received specific vaccinations against certain infections, unless they have proof that they do not respond to vaccines.
  • Women who can have children must have negative pregnancy tests and agree to use specific birth control methods from the start of the study until 90 days after the last dose of the study drug.

Who Cannot Join the Study?

  • Patients who have other kidney diseases not related to complement 3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN).
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication as required.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of severe allergic reactions to the study medication or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a serious medical condition that might interfere with the study results.
  • Patients who have had a kidney transplant.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Medizinische Hochschule Hannover Hanover Germany
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Istituto Di Ricerche Farmacologiche Mario Negri Ranica Italy
Azienda Ospedaliera di Padova Padua Italy
Universitaetsklinikum Regensburg AöR Regensburg Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Utwdvwavqtxf Mdtrvcn Cktgsbz Gyjjwvbjj Groningen The Netherlands
Acgnacnsd Uon Amsterdam The Netherlands
Sdoaugryx Rgvzjlu Uktowjhbdl Msjlnkv Cbppof Nijmegen The Netherlands
Ascnjgn Uvgpp Sljfeuewa Lwqbed Dr Bnbsomo Bologna Italy

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.04.2022
Germany Germany
Not recruiting
13.04.2022
Italy Italy
Not recruiting
13.04.2022
The Netherlands The Netherlands
Not recruiting
13.04.2022

Trial locations

Investigated drugs:

Pegcetacoplan is a medication being studied for its effectiveness in treating patients with certain kidney conditions, specifically C3 Glomerulopathy (C3G) and Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN). The study aims to see if this medication can help reduce protein levels in the urine, which is a sign of kidney damage. Pegcetacoplan is given as an injection under the skin twice a week.

Investigated diseases:

Complement 3 Glomerulopathy (C3G) – This is a rare kidney disease characterized by the abnormal deposition of complement protein C3 in the glomeruli, which are the filtering units of the kidney. The disease leads to inflammation and damage in the glomeruli, causing them to function improperly. Over time, this can result in proteinuria, where excess protein is found in the urine, and can affect kidney function. The progression of C3G can vary, with some individuals experiencing slow progression while others may have a more rapid decline in kidney function. Symptoms may include swelling, high blood pressure, and changes in urine color or volume. The exact cause of C3G is not fully understood, but it involves dysregulation of the complement system, a part of the immune system.

Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) – This is a type of kidney disease where immune complexes, which are clusters of antibodies and antigens, deposit in the glomeruli, leading to inflammation and thickening of the glomerular basement membrane. This condition disrupts the normal filtering process of the kidneys, resulting in proteinuria and hematuria, which is the presence of blood in the urine. IC-MPGN can cause a gradual decline in kidney function over time, and symptoms may include swelling, fatigue, and high blood pressure. The disease is often associated with other conditions that cause immune complex formation, such as infections or autoimmune diseases. The progression of IC-MPGN can vary widely among individuals, with some experiencing stable kidney function for years, while others may have a more rapid decline.

Trial ID:
2024-514130-20-00
Protocol code:
APL2-C3G-310
NCT ID:
NCT05067127
Trial Phase:
Therapeutic confirmatory (Phase III)

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