C3GNCT04729062
C3G/Primary IC-MPGN EAP
A study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc..
Trial summary
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- C3G, IC-MPGN, C3 Glomerulopathy
- What is being tested?
- Pegcetacoplan
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patient is aged at least 12 years or older weighing at least 30 kg.
- A biopsy has confirmed diagnosis of primary C3G or IC-MPGN or patient has a biopsy-proven histologic recurrence in posttransplant.
- There is evidence of active renal disease, based on at least 1 g/day of proteinuria from 24-hour urine collection or uPCR ≥1 g/g from random urine in native kidney. There is no minimum level of proteinuria for post-transplant recurrence.
- Patient has a limited response to treatment regimens for C3G/IC-MPGN, and may include:
- Angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, and/or sodium-glucose cotransporter-2 inhibitor therapy
- Other medications that can affect proteinuria (eg, steroids, mycophenolate mofetil, and/or other immunosuppressants that the patient is receiving for treatment of C3G or IC-MPGN)
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- Patient has received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) as per the Advisory Committee on Immunization Practices (ACIP) recommendations for adults or children with complement deficiencies. Vaccination series should be initiated at least 14 days prior to enrollment. If patient disease is severe and requires immediate treatment, administer required vaccine as soon as possible and provide patients with 2 weeks of prophylactic antibiotics.
- Female patients of childbearing potential, defined as any women who have experienced menarche and who are not permanently sterile or postmenopausal, must have negative blood pregnancy tests at screening (and negative urine pregnancy tests on day 1) and must agree to use protocol-defined methods of contraception from screening through at least 90 days after receiving the last dose of pegcetacoplan.
- Patients above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of patients under the legal age of consent must be willing and able to provide informed consent; where appropriate, patients under the legal age of consent must also give their assent to participation in the program.
- Patient is willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration.
- Patient currently resides in and is a resident of the US.
Who cannot join
- C3G/IC-MPGN is secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, a systemic autoimmune disease such as systemic lupus erythematosus, chronic antibody-mediated rejection, or a medication), in the opinion of the treating physician.
- Patient has current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology during screening that is indicative of infection with any of these viruses.
- Patient's body weight is greater than 100 kg at screening.
- Patient has hypersensitivity to pegcetacoplan or to any of the excipients.
- Patient has history of meningococcal disease.
- Patient has a severe infection (eg, requiring IV antibiotic therapy) within 14 days prior to the first dose of pegcetacoplan.
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- Patient has an absolute neutrophil count less than 1000 cells/mm3 at screening.
- Patient has other significant renal disease.
- Based on the investigator's opinion, the patient has significant glomerulosclerosis or interstitial fibrosis on kidney biopsy.
- Patient is participating in any other investigational drug trial.
- Patient is a female who is pregnant or who is currently breastfeeding.
- Patient has the inability to cooperate or has any condition that, in the opinion of the treating physician, creates an undue risk for the patient by participating in the program.
- There is evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the treating physician.
- There is the presence or suspicion of severe infection during the screening period (including but not limited to recurrent or chronic infections) that, in the opinion of the treating physician, may place the patient at unacceptable risk by program participation.
- There is a known or suspected hereditary fructose intolerance.
About this study
Official title: US Early Access Program for the Treatment of Patients With C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis With Pegcetacoplan
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN.
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G)
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729062
- Sponsor's protocol ID
- APL2-C3G-801
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2021
- Last updated
- 6 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US Early Access Program for the Treatment of Patients With C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis With Pegcetacoplan
- ClinicalTrials.gov ID
- NCT04729062
- Acronym / sponsor ID
- APL2-C3G-801
- Conditions
- C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G)
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Apellis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is aged at least 12 years or older weighing at least 30 kg.
- A biopsy has confirmed diagnosis of primary C3G or IC-MPGN or patient has a biopsy-proven histologic recurrence in posttransplant.
- There is evidence of active renal disease, based on at least 1 g/day of proteinuria from 24-hour urine collection or uPCR ≥1 g/g from random urine in native kidney. There is no minimum level of proteinuria for post-transplant recurrence.
- Patient has a limited response to treatment regimens for C3G/IC-MPGN, and may include:
- Patient has received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) as per the Advisory Committee on Immunization Practices (ACIP) recommendations for adults or children with complement deficiencies. Vaccination series should be initiated at least 14 days prior to enrollment. If patient disease is severe and requires immediate treatment, administer required vaccine as soon as possible and provide patients with 2 weeks of prophylactic antibiotics.
Key exclusion criteria (15 listed)
- C3G/IC-MPGN is secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, a systemic autoimmune disease such as systemic lupus erythematosus, chronic antibody-mediated rejection, or a medication), in the opinion of the treating physician.
- Patient has current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology during screening that is indicative of infection with any of these viruses.
- Patient's body weight is greater than 100 kg at screening.
- Patient has hypersensitivity to pegcetacoplan or to any of the excipients.
- Patient has history of meningococcal disease.
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pegcetacoplan in people with C3G and IC-MPGN, run by Apellis Pharmaceuticals, Inc..
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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
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 6 Nov 2025.