What side effects are associated with this type of intervention?

Common treatments for Membranoproliferative Glomerulonephritis (MPGN) include immunosuppressive therapies such as corticosteroids, cyclophosphamide, and mycophenolate mofetil. Known side effects of these treatments can include increased risk of infections, gastrointestinal disturbances, and potential kidney toxicity. For treatments similar to Pegcetacoplan, which is a C3 complement inhibitor, side effects may include injection site reactions, increased risk of infections, and potential hematologic abnormalities. It is important to monitor patients closely for these adverse effects during treatment.

What prior FDA approvals exist?

There are limited FDA-approved treatments specifically for Membranoproliferative Glomerulonephritis (MPGN). However, therapies targeting the complement system, such as eculizumab, a C5 complement inhibitor, have been used off-label for related conditions like atypical Hemolytic Uremic Syndrome (aHUS) and C3 Glomerulopathy, which share pathophysiological mechanisms with MPGN. Pegcetacoplan, a C3 complement inhibitor, is currently being studied for its efficacy in post-transplant recurrence of C3G or IC-MPGN, indicating a potential new therapeutic approach targeting the complement pathway in these diseases.

What other types of research exist?

Promising novel alternatives to Pegcetacoplan for MPGN patients include other complement inhibitors such as Eculizumab and Ravulizumab, which target the complement pathway. Additionally, emerging therapies like Narsoplimab, a MASP-2 inhibitor, and LNP023 (Iptacopan), a factor B inhibitor, are being investigated for their potential benefits in complement-mediated kidney diseases.

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Complement Inhibitor

Pegcetacoplan for Recurrent Kidney Disease (NOBLE Trial)

Phase 2

Waitlist Available

Research Sponsored by Apellis Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a medication called pegcetacoplan in patients who have had their kidney disease come back after a transplant. The medication aims to reduce inflammation and prevent further kidney damage by blocking certain immune system activities. The study will evaluate how safe and effective this treatment is for these patients.

Who is the study for?

This trial is for adults who've had a kidney transplant and are now facing a recurrence of certain kidney diseases (C3G or IC-MPGN). Participants should have stable or worsening disease, adequate kidney function, no significant other renal diseases, and must be vaccinated against specific infections. They can't join if they have certain infections like HIV or hepatitis, previous pegcetacoplan treatment, low neutrophil count, weigh over 100 kg, or have certain cancer histories.

What is being tested?

The study tests the safety and effectiveness of Pegcetacoplan in patients with post-transplant recurrence of C3G/IC-MPGN. It's an open-label Phase 2 trial where everyone knows what treatment is being given; some will receive Pegcetacoplan while others may not as part of the control group.

What are the potential side effects?

While not specified here, side effects could include reactions at the injection site since Pegcetacoplan is administered this way. Patients might also experience immune system-related issues due to its nature as a complement inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 3 trial • 80 Patients • NCT03500549

41%

Injection site erythema

15%

Injection site pruritus

13%

Headache

13%

Injection site swelling

13%

Diarrhoea

10%

Injection site reaction

Nausea

Pyrexia

Injection site pain

Fatigue

Injection site induration

Dyspnoea

Nasopharyngitis

Contusion

Dizziness

Chromaturia

Vaccination site pain

Pain in extremity

Back pain

Myalgia

Vaccination complication

Anxiety

Thrombocytopenia

Cough

Abdominal pain

Abdominal discomfort

Arthralgia

Injection site bruising

Sepsis

Haemolysis

Sinusitis

Vomiting

Oral herpes

Anaemia

Asthenia

Palpitations

Abdominal distension

Constipation

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Run-in Period: Pegcetacoplan + Eculizumab

Open-label Period: Pegcetacoplan

RCP: Eculizumab

RCP: Pegcetacoplan

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.

Group II: Group 1Experimental Treatment1 Intervention

Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegcetacoplan

2015

Completed Phase 3

~380

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Membranoproliferative Glomerulonephritis (MPGN) often involves dysregulation of the complement system, particularly the alternative pathway. Treatments like Pegcetacoplan, a C3 complement inhibitor, work by blocking the activation of C3, a crucial component in the complement cascade. This inhibition prevents the formation of downstream inflammatory complexes such as C5b-9, which are responsible for glomerular damage and proteinuria. By targeting this pathway, these treatments aim to reduce inflammation and preserve kidney function, offering a promising therapeutic approach for MPGN patients who suffer from complement-mediated renal damage.

Role of terminal complement pathway in the heterologous phase of antiglomerular basement membrane nephritis.Alternative Pathway Is Essential for Glomerular Complement Activation and Proteinuria in a Mouse Model of Membranous Nephropathy.Treatment options for C3 glomerulopathy.

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Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor

25 Previous Clinical Trials

4,267 Total Patients Enrolled

Media Library

Pegcetacoplan (Complement Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04572854 — Phase 2

Membranoproliferative Glomerulonephritis Research Study Groups: Group 1, Group 2

Membranoproliferative Glomerulonephritis Clinical Trial 2023: Pegcetacoplan Highlights & Side Effects. Trial Name: NCT04572854 — Phase 2

Pegcetacoplan (Complement Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04572854 — Phase 2

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