2023-504625-39-00招募中3 期
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALE)
Apellis Pharmaceuticals Inc.21 个研究点 分布在 8 个国家目标入组 66 人开始时间: 2023年8月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 21
- 主要终点
- The log-transformed ratio of urine protein-to-creatinine ratio (uPCR) over time compared to pretreatment baseline.
研究概览
简要总结
The primary objective of this study is to establish the long-term safety and efficacy of pegcetacoplan in participants with C3G or IC-MPGN.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Follow-up Period (8 Weeks)
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Completed participation in Study APL2-C3G-310 through the Week 52 visit requirements.
- •Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator.
- •Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2–C3G–
- •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 Advisory Committee on Immunization Practices recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines.
- •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 visit 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.
- •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.
- •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.
- •Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration.
排除标准
- •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.
- •Inability or unwillingness to cooperate with the requirements of the protocol.
- •Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results.
- •Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator.
结局指标
主要结局
The log-transformed ratio of urine protein-to-creatinine ratio (uPCR) over time compared to pretreatment baseline.
The log-transformed ratio of urine protein-to-creatinine ratio (uPCR) over time compared to pretreatment baseline.
次要结局
- 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 the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) Scale score.
- 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.
研究者
Clinical Trial
Scientific
Apellis Pharmaceuticals Inc.
研究点 (21)
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