APPROVED_FOR_MARKETINGNot Applicable

C3G/Primary IC-MPGN EAP

Plain-language summary

This is an Early Access Program (EAP) which will provide access to pegcetacoplan for eligible participants with C3G and Primary IC-MPGN.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. 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)
✓. 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.

Exclusion criteria

✕. 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.
✕. Patient has an absolute neutrophil count less than 1000 cells/mm3 at screening.
✕. Patient has other significant renal disease.

Trial details

NCT IDNCT04729062

SponsorApellis Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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