C3GPhase 2NOBLENCT04572854
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
A Phase 2 study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc. at 25 sites in 11 countries.
Trial summary
This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C3G, IC-MPGN, Renal Transplant
- What is being tested?
- Pegcetacoplan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 25 sitesin 11 countries
- Study dates
- 7 Sep 2021to 20 Jan 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at screening
- Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN
- Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
- eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
- No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy
- Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
- Have received required vaccinations against N. meningitidis, S. pneumoniae, and H. influenzae (type B) or agree to receive vaccinations, if applicable vaccination records are not available. Vaccination is mandatory unless documented evidence exists that subjects are non-responders to vaccination.
Who cannot join
- Absolute neutrophil count <1000 cells/mm3 during screening
- Previous treatment with pegcetacoplan
- Evidence of rejection on the screening renal allograft biopsy that requires treatment
- Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
- Weight more than 100 kg at screening
- Hypersensitivity to pegcetacoplan or any of the excipients
Show all 14Show fewer
- History of meningococcal disease
- Malignancy, except for the following:
- Cured basal or squamous cell skin cancer
- Curatively treated in situ disease
- Malignancy free and off treatment for ≥5 years
- Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection, or a medication) that would, in the opinion of the investigator, confound interpretation of the study results
- Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening
- Known or suspected hereditary fructose intolerance.
Trial locations and contacts
25 sites in 11 countries.
25 sites in 11 countries
United States7 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Keck School of Medicine, University of Southern California
Los Angeles, California, 900033
NYU Langone Health Transplant Insitute
New York, New York, 10016
CUIMC
New York, New York, 10032
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Washington University, St.Louis
St Louis, Missouri, 63110
Brazil4 sites
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, CEP 30150-221
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, São Paulo, 18618-686
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403-000
France3 sites
Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology
Lille, 59000
Hopital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69437
Center Hospitalier Universitaire de Montpellier
Montpellier, 34295 CEDEX 5
Argentina2 sites
Hospital Universitario Fundacion Favaloro
Buenos Aires, C1093AAS
Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner
San Juan Bautista, Buenos Aires, B1888AAE
Australia2 sites
Monash Medical Centre
Clayton, 3168
The Royal Melbourne Hospital
Parkville, Victoria, 3050
United Kingdom2 sites
Imperial College Healthcare NHS Trust
London, W12 0HS
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Spain1 site
Hospital Universitario 12 de Octubre, Nephrology Department
Madrid, 28041
About this study
Official title: An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN
This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.
- Conditions
- C3G, IC-MPGN, Renal Transplant, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Dense Deposit Disease (DDD)
- Being tested
- Pegcetacoplan
- Medical subject headings
- Glomerulonephritis, Membranoproliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegcetacoplanDrug
Complement (C3) Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study. Receives: Drug: Pegcetacoplan |
| Group 2 | Other | No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment. Receives: Drug: Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12
C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 12
Secondary outcomes (8)
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52
C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52
C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. Number of subjects who demonstrated a shift of C3c staining from baseline to Week 12 and baseline to Week 52 are presented.
Measured: Baseline (Day 1), Week 12 and Week 52
Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52
eGFR was calculated by using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation. Stabilization or improvement in eGFR was defined as no more than a 25% decrease relative to baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52
Stabilization or improvement in serum creatinine was defined as no increase or an increase of no more than 25% from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Change From Baseline in Serum Creatinine Concentration at Week 52
Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Percentage Change From Baseline in Serum Creatinine Concentration at Week 52
Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
Measured: Baseline (Day 1) and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start7 Sep 2021
- Primary completion27 Feb 2023
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for C3GStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572854
- Sponsor's protocol ID
- APL2-C3G-204
- Acronym
- NOBLE
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2020
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC-MPGN
- ClinicalTrials.gov ID
- NCT04572854
- Acronym / sponsor ID
- NOBLE / APL2-C3G-204
- Conditions
- C3G, IC-MPGN, Renal Transplant, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Dense Deposit Disease (DDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: PegcetacoplanPegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study. |
| Group 2 | Other | Drug: PegcetacoplanNo intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age at screening
- Must have clinical and pathologic evidence of recurrent C3G or IC-MPGN
- Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
- eGFR ≥15 mL/min/1.73 m2, calculated by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
- No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal allograft biopsy
Key exclusion criteria (14 listed)
- Absolute neutrophil count <1000 cells/mm3 during screening
- Previous treatment with pegcetacoplan
- Evidence of rejection on the screening renal allograft biopsy that requires treatment
- Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection with any of these viruses
- Weight more than 100 kg at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegcetacoplanComplement (C3) Inhibitor | Drug | Group 1, Group 2 |
Primary outcome
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12
Time frame: Baseline (Day 1) and Week 12
C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects.
8 secondary outcomes
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52
Time frame: Baseline (Day 1) and Week 52
Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52
Time frame: Baseline (Day 1), Week 12 and Week 52
Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time frame: Baseline (Day 1) and Week 52
Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52
Time frame: Baseline (Day 1) and Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time frame: Baseline (Day 1) and Week 52
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time frame: Baseline (Day 1) and Week 52
Change From Baseline in Serum Creatinine Concentration at Week 52
Time frame: Baseline (Day 1) and Week 52
Percentage Change From Baseline in Serum Creatinine Concentration at Week 52
Time frame: Baseline (Day 1) and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc. at 25 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Brazil, France, Argentina, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 (time frame: Baseline (Day 1) and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.