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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
No Placebo-Only Group

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 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
9%
Nausea
8%
Pyrexia
8%
Injection site pain
6%
Fatigue
6%
Injection site induration
5%
Dyspnoea
5%
Nasopharyngitis
4%
Dizziness
4%
Chromaturia
4%
Contusion
4%
Vaccination site pain
4%
Pain in extremity
4%
Back pain
4%
Myalgia
3%
Vaccination complication
3%
Anxiety
3%
Thrombocytopenia
3%
Cough
3%
Abdominal pain
3%
Abdominal discomfort
3%
Arthralgia
3%
Injection site bruising
3%
Sepsis
1%
Sinusitis
1%
Haemolysis
1%
Vomiting
1%
Oral herpes
1%
Anaemia
1%
Asthenia
1%
Palpitations
1%
Abdominal distension
1%
Constipation
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-in Period: Pegcetacoplan + Eculizumab
Open-label Period: Pegcetacoplan
RCP: Eculizumab
RCP: Pegcetacoplan

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~420

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.

Find a Location

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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