EUCTR2020-002637-15-IT进行中（未招募）1 期
An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE
APELLIS PHARMACEUTCIALS, INC.0 个研究点目标入组 12 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Individuals must meet all of the following criteria at screening visits to be included in the study:
- •1. Patients of at least 18 years of age at screening
- •2. Patients must have clinical and pathologic evidence of recurrent C3G or IC-MPGN, as evidenced by all of the following:a. A diagnosis of C3G or IC-MPGN, with at least 2+ staining for C3c in therenal allograft, confirmed by a central pathologist, based on the screening renal allograft biopsyb. Clinical evidence of C3G or IC-MPGN recurrence in the form of at least 1 g/day of proteinuria in a 24-hour urine collection that is attributable todisease recurrence in the opinion of the investigatorc. C3G or IC-MPGN must be primary and not secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, autoimmunity, chronic antibody-mediated rejection, chronic thrombotic microangiopathy, or a medication)
- •3. Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months preceding the first dose of pegcetacoplan
- •4. eGFR =30 mL/min/1.73 m2, calculated by the Chronic Kidney Disease–Epidemiology Collaboration (CKD-EPI) creatinine equation for adults
- •5. No more than 50% glomerulosclerosis or interstitial fibrosis on the screening renal biopsy
- •6. Stable regimen for recurrent C3G/IC-MPGN for at least 4 weeks prior to the screening renal allograft biopsy and from the time of the screening renal allograft biopsy until randomization
- •7. Willing to receive required vaccinations against N. meningitides, S. pneumoniae, and H. influenzae if applicable vaccination records are not available
- •8. Women of childbearing potential (WOCBP) must have a negative bloodpregnancy test at screening (and negative urine pregnancy at Visit 4) and must agree to use protocoldefined methods of contraception from screening through 12 weeks after receiving last dose of pegcetacoplan
- •9. Men must agree to use protocol-defined methods of contraception andagree to refrain from donating semen from screening through 12 weeks after receiving last dose of pegcetacoplan
- •10. Willing and able to provide written informed consent
- •11. Able to understand and willing to comply with all scheduled procedures and other requirements of the study in the opinion of the investigator
- •12. Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Individuals meeting any of the following criteria at screening or baselineare ineligible to participate in this study:
- •1. Absolute neutrophil count <1000 cells/mm3 during screening (not including Day 1)
- •2. Previous treatment with pegcetacoplan
- •3. Evidence of rejection on the screening renal allograft biopsy that requires treatment
- •4. Diagnosis or history of HIV, hepatitis B, or hepatitis C infection or positive serology at screening indicative of infection
- •5. Malignancy, except for the following:a. Cured basal or squamous cell skin cancerb. Curatively treated in situ diseasec. Malignancy free and off treatment for =5 years
- •6. Significant renal disease in the renal allograft secondary to another condition (eg, infection, malignancy, monoclonal gammopathy, rejection,or a medication) that would confound interpretation of the study results
- •7. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or 5 half-lives from the last dose of the investigational agent (whichever is longer) prior to screening period
- •8. Women who are currently breastfeeding
- •9. Inability to cooperate or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
- •10. Evidence of drug or alcohol abuse or dependence, in the opinion of the investigator
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