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Complement Inhibitor

Pegcetacoplan for Membranoproliferative Glomerulonephritis (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 12 weeks after randomization
Awards & highlights

NOBLE Trial Summary

This trial will test a new drug to see if it is safe and effective in treating people who have had a kidney transplant and whose disease has returned.

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.Check my eligibility
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.See study design
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.

NOBLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.
Secondary outcome measures
The proportion of subjects with reduction in C3c staining on renal biopsy
The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR)
The proportion of subjects with stabilization or improvement of serum creatinine concentration

Side effects data

From 2020 Phase 3 trial • 80 Patients • NCT03500549
17%
Haemolysis
16%
Nasopharyngitis
14%
Diarrhoea
12%
Injection site erythema
12%
Cough
10%
Headache
10%
Fatigue
9%
Urinary tract infection
9%
Upper respiratory tract infection
8%
Oral herpes
8%
Pyrexia
8%
Oropharyngeal pain
8%
Arthralgia
6%
Injection site induration
6%
Injection site pruritus
6%
Pain in extremity
5%
Myalgia
5%
Asthenia
5%
Injection site pain
5%
Anxiety
5%
Abdominal distension
5%
Acute kidney injury
5%
Contusion
4%
Dizziness
4%
Vomiting
4%
Hyperbilirubinaemia
4%
Injection site bruising
4%
Hypertension
4%
Thrombocytopenia
4%
Abdominal pain
4%
Erythema
4%
Sinusitis
3%
Chromaturia
3%
Injection site reaction
3%
Nausea
3%
Gastroenteritis
3%
Vaccination complication
3%
Anaemia
3%
Dyspnoea
3%
Constipation
3%
Back pain
3%
Decreased appetite
1%
Injection site swelling
1%
Intestinal ischaemia
1%
Allergy to immunoglobulin therapy
1%
Haemolytic anaemia
1%
Cholelithiasis
1%
Haematoma muscle
1%
COVID-19
1%
Insomnia
1%
Haemoglobinuria
1%
Cytopenia
1%
Small intestinal obstruction
1%
Epistaxis
1%
Ovarian cyst
1%
Hypersensitivity pneumonitis
1%
Oedematous pancreatitis
1%
Biliary sepsis
1%
Diverticulitis
1%
Post procedural sepsis
1%
Sepsis
1%
Palpitations
1%
Diffuse large B-cell lymphoma
1%
Deep vein thrombosis
1%
Acute myeloid leukaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Period: Pegcetacoplan
Run-in Period: Pegcetacoplan + Eculizumab
RCP: Eculizumab
RCP: Pegcetacoplan

NOBLE 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

Find a Location

Who is running the clinical trial?

Apellis Pharmaceuticals, Inc.Lead Sponsor
24 Previous Clinical Trials
4,012 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a pioneering medical study?

"At present, there are 10 active clinical studies for Pegcetacoplan in 26 nations and 149 cities. Sponsored by Apellis Pharmaceuticals, Inc., the first trial was conducted back in 2018 with 600 participants. Afterward, 8 more trials have been concluded successfully up until now."

Answered by AI

Is the enrollment period for this clinical trial still open?

"Affirmative. Clinicaltrials.gov data attests to the fact that recruitment is currently underway for this research project, which was first posted on February 23rd 2021 and last revised on April 5th 2022. The trial requires 12 individuals across five sites."

Answered by AI

How many participants are being recruited for this investigation?

"To carry out this medical trial, 12 participants that meet the predetermined qualifications are needed. These individuals can register at a few designated centres such as NYU Langone Health Transplant Institute in New york and Washington University, St.Louis in Saint Louis Missouri."

Answered by AI

Has Pegcetacoplan been given the greenlight by the FDA?

"Our company has rated pegcetacoplan's safety at a 2 because, although there is evidence that it can be administered safely, efficacy data needs to be acquired in Phase 3 trials."

Answered by AI

In how many distinct settings is this research experiment taking place?

"Five medical centres are currently managing this trial, including NYU Langone Health Transplant Institute in New york City, Washington University at St. Louis and Children's Hospital Colorado in Aurora. Additionally there are two other healthcare sites involved with the study."

Answered by AI

Has Pegcetacoplan been subjected to other experimental tests prior to now?

"The first scientific exploration of pegcetacoplan began at Universitäts-Augenklinik Bonn in 2018. Since then, 8 trials have been successfully completed and an additional 10 active studies are underway, primarily located around New york City."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
2021. "Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04572854.
~3 spots leftby May 2025
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