C3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN) MedDRA version: 20.0 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10077827 Term: C3 glomerulopathy System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: LLT Classification code 10027168 Term: Membranoproliferative glomerulonephritis
Conditions
Sponsors
Apellis Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.completed participation in Study APL2-C3G -310 through the week 52 visit requirements 2.experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator 3.must remain on a stable regimen for C3G or IC -MPGN treatment according to the requirements of Study APL2-C3G -310 4.received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G -310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines 5.Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at v isit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan. 6.Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan. 7.Participants 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 participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study. 8.willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1.female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug 2.inability or unwillingness to cooperate with the requirements of the protocol 3.any condition that, in the opinion of the investigator, creates an undue risk for the participantby participating in the study or is likely to confound interpretation of the study results 4.evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to establish the long-term safety and efficacy of pegcetacoplan in participants with C3G or IC-MPGN;Secondary Objective: An additional exploratory objective is to characterize the long-term effects of treatment with pegcetacoplan in participants with C3G or IC-MPGN, including PK, pharmacodynamics (PD), and immunogenic response.;Primary end point(s): The primary efficacy endpoint is the proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.;Timepoint(s) of evaluation of this end point: (uPCR) value over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •the proportion of participants with estimated glomerular filtration rate (eGFR) values that are stable or improved from pretreatment values over time •the proportion of participants achieving proteinuria <1 g/day over time •change from pretreatment in uPCR values over time •change from pretreatment in eGFR values over time •for participants with pretreatment serum albumin levels below the lower limit of normal (LLN), the proportion of participants with normalization of serum albumin levels over time •for participants with pretreatment serum C3 levels below the LLN, the proportion of participant s with normalization of serum C3 levels over time •the proportion of participants with progression to a clinical composite outcome (at least one of the following: doubling of serum creatinine, progression to chronic kidney disease stage 5 or ESRD, renal transplantation, or death) over time ;Timepoint(s) of evaluation of this end point: (eGFR), uPCR, serum albumin level values over time | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Peru, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trial
Apellis Pharmaceuticals, Inc.
Outcome results
None listed