Study on the Safety and Effectiveness of Pegcetacoplan for Patients with Post-Transplant Recurrence of C3 Glomerulopathy or Immune Complex Membranoproliferative Nephritis

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What is this study about?

This clinical trial is focused on studying the treatment of two kidney diseases: Complement 3 Glomerulopathy (C3G) and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN). These conditions can occur after a kidney transplant and involve the immune system attacking the kidney, leading to damage. The treatment being tested is a medication called pegcetacoplan, which is given as a solution for infusion. This medication is designed to help improve the condition of the kidneys by targeting specific parts of the immune system.

The purpose of the study is to evaluate how effective pegcetacoplan is in improving the health of the kidneys affected by C3G or IC-MPGN. Participants in the study will receive pegcetacoplan through a subcutaneous injection, which means it is administered under the skin. The study will last for a period of 12 weeks, during which the effects of the treatment on the kidney condition will be closely monitored. An ambulatory syringe infusion system, known as the FreedomEdge® Syringe Infusion System, will be used to administer the medication.

Throughout the study, participants will undergo regular check-ups to assess the safety and effectiveness of the treatment. The main goal is to see if there is a reduction in the damage to the kidneys, as indicated by changes in specific markers in the kidney tissue. The study will also monitor other health indicators, such as kidney function and overall safety, to ensure that the treatment is both effective and safe for participants. The trial is open-label, meaning both the participants and the researchers know which treatment is being administered.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health condition, and willingness to comply with study procedures.

Participants must have a confirmed diagnosis of complement 3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN).

2 initial assessment

An initial assessment is conducted to evaluate the current health status, including a renal biopsy to confirm the presence of C3G or IC-MPGN.

Participants must have stable or worsening disease and meet specific health criteria, such as a certain level of kidney function.

3 treatment administration

The treatment involves the administration of pegcetacoplan, a solution for infusion, given through a subcutaneous injection.

Participants or their caregivers must be able to administer the medication as per the study requirements.

4 treatment duration

The treatment with pegcetacoplan is administered over a period of 12 weeks initially, with the possibility of extension up to 52 weeks based on the study’s design.

The primary goal is to observe a reduction in C3c staining on renal biopsy after 12 weeks.

5 follow-up assessments

Regular follow-up assessments are conducted to monitor the effectiveness and safety of the treatment.

These assessments include monitoring kidney function, serum creatinine levels, and any adverse events.

6 completion of study

Upon completion of the study period, a final assessment is conducted to evaluate the overall outcomes of the treatment.

Participants’ health data is analyzed to determine the efficacy and safety of pegcetacoplan in treating C3G or IC-MPGN.

Who Can Join the Study?

Must be at least 18 years old at the time of screening.
Willing and able to provide written informed consent, which means agreeing to participate after understanding the study details.
Able to understand and willing to follow all scheduled procedures and other study requirements, as judged by the study doctor.
Willing and able to self-administer the study medication, pegcetacoplan, or have a caregiver who can do it.
Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, which are specific kidney conditions. This includes:

A confirmed diagnosis of C3G or IC-MPGN with specific staining in the kidney transplant, verified by a central pathologist during a screening kidney biopsy.
The condition must be primary, meaning it is not caused by another condition like infection, cancer, or certain immune disorders.

The disease must be stable (not improving) or getting worse in the two months before starting the study medication, according to the study doctor.
eGFR (a measure of kidney function) must be at least 15 mL/min/1.73 m², calculated using a specific formula for adults.
No more than 50% of the kidney tissue should show scarring or damage in the screening kidney biopsy.
Must have been on a stable treatment plan for recurrent C3G/IC-MPGN for at least four weeks before the screening kidney biopsy and until the study starts.
Must have received required vaccinations against certain bacteria (N. meningitidis, S. pneumoniae, and H. influenzae type B) or agree to get vaccinated if records are not available. Vaccination is mandatory unless there is proof that the person does not respond to vaccines.
Women who can have children must have a negative pregnancy test at screening and agree to use specific birth control methods from screening through 12 weeks after the last dose of the study medication.
Men must agree to use specific birth control methods and agree not to donate semen from screening through 12 weeks after the last dose of the study medication.

Who Cannot Join the Study?

Patients who have a different kidney condition than the one being studied.
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 have a medical condition that could interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who have a serious illness that could affect their ability to participate in the study.
Patients who are unable to give informed consent to participate in the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country	Status
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy
Stichting Radboud University Medical Center	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	18.12.2020
Italy	Not recruiting	18.12.2020
The Netherlands	Not recruiting	18.12.2020

Trial locations

Investigated drugs:

Pegcetacoplan

Pegcetacoplan is a medication being studied for its ability to treat certain kidney conditions, specifically complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). These conditions can recur after a kidney transplant, and pegcetacoplan is being tested to see if it can help improve the health of the kidneys by addressing the underlying issues related to these diseases.

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 to the glomeruli, causing them to function improperly. Over time, this can result in proteinuria, hematuria, and reduced kidney function. The progression of C3G can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid progression. The exact cause of C3G is not fully understood, but it is believed to involve 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 symptoms such as blood in the urine, proteinuria, and decreased kidney function. IC-MPGN can progress at different rates, with some individuals experiencing a gradual decline in kidney function, while others may have more rapid progression. The disease is associated with immune system abnormalities, but the exact mechanisms are not completely understood.

Trial ID:

2024-511544-36-00

Protocol code:

APL2-C3G-204

NCT ID:

NCT04572854

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Pegcetacoplan for Patients with Post-Transplant Recurrence of C3 Glomerulopathy or Immune Complex Membranoproliferative Nephritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?