Seirei Hamamatsu General Hospital | General Clinical Research Center
Status and phase
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Treatments
About
This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Aged at least 18 years; where approved, adolescents (aged 12-17 years) weighing at least 30 kg may also be enrolled.
A diagnosis of primary C3G or IC-MPGN (with or without previous renal transplant).
Evidence of active renal disease, based on one or more of the following:
In adults or adolescents with a baseline renal biopsy (either one collected during screening or a historic biopsy collected within 28 weeks prior to randomization), at least 2+ C3c staining on the baseline renal biopsy.
In adolescents not providing a baseline renal biopsy, at least one of the following:
No more than 50% global glomerulosclerosis or interstitial fibrosis on the baseline biopsy for adult participants or adolescent participants providing a baseline biopsy.
At least 1 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1000 mg/g in at least 2 first-morning spot urine samples collected during screening.
eGFR ≥30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease-Epidemiology Collaboration creatinine equation for adults or the Bedside Schwartz equation for adolescents.
Stable regimen for C3G/IC-MPGN treatment, as described below:
Have received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) within 5 years prior to randomization or agree to receive vaccinations during screening.
Exclusion criteria
Previous exposure to pegcetacoplan.
C3G/IC-MPGN 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 investigator.
Current or prior diagnosis of human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) infection or positive serology during screening that is indicative of infection with any of these viruses.
Body weight greater than 100 kg at screening.
Hypersensitivity to pegcetacoplan or to any of the excipients.
History of meningococcal disease.
Malignancy, except for the following:
Severe infection (eg, requiring IV antibiotic therapy) within 14 days prior to the first dose of pegcetacoplan.
An absolute neutrophil count <1000 cells/mm3 at screening.
Use of rituximab, belimumab, or any approved or investigational anticomplement therapy other than pegcetacoplan within 5 half-lives of that product prior to the screening period.
Female participants who are 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.
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 investigator, may place the participant at unacceptable risk by study participation.
Known or suspected hereditary fructose intolerance.
Primary purpose
Allocation
Interventional model
Masking
90 participants in 2 patient groups, including a placebo group
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Central trial contact
Apellis Clinical Trial Information Line
Data sourced from clinicaltrials.gov
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