NCT03221842终止3 期
A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 63
- 试验地点
- 26
- 主要终点
- Percent of Participants With Loss-of-response During Treatment Period 2 (TP2)
研究概览
简要总结
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years of age;
- •Evidence of at least one donor-specific antibody (DSA);
- •Recipient of a kidney transplant;
- •Achieved a steady-state, post-transplant eGFR ≥ 40 mL/min/1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;
- •Acute AMR.
排除标准
- •Recipient of an en bloc kidney transplant;
- •Current active hepatitis C virus (HCV) infection;
- •Active bacterial or fungal infection;
- •Ongoing dialysis >2 weeks;
- •Known congenital bleeding or coagulopathy disorder;
- •Current cancer or a history of cancer;
- •Female subjects who are pregnant or breast feeding;
- •Male or female subjects who are unwilling to use contraception or who are not surgically sterile.
研究组 & 干预措施
C1-INH
Experimental
C1-esterase inhibitor
干预措施: C1-esterase inhibitor (Drug)
Placebo
Placebo Comparator
Excipients of C1-INH plus albumin
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of Participants With Loss-of-response During Treatment Period 2 (TP2)
时间窗: Up to 38 weeks
Loss of response is defined as 1 of the following, whichever occurs first: * Decline in Estimated Glomerular Filtration Rate (eGFR), or * Allograft failure, or * Subject death by any cause.
次要结局
- Percent of Participants With Any Adverse Event (AE) Assessed as Related to Investigational Product(Up to approximately 42 weeks after the time of first investigational product administration)
- Absolute Change From Baseline in Estimated Glomerular Filtration Rate at End of TP2(Baseline and 38 weeks)
- Time to All-cause Allograft Failure Through the Follow up Period(Up to approximately 208 weeks)
- Absolute Change From Baseline in Estimated Glomerular Filtration Rate at End of Treatment Period 1 (TP1)(Baseline and 13 weeks)
- Percent of Responders at the End-of-TP1(Up to 13 weeks)
- Mean Pre-dose C1-esterase Inhibitor Functional Activity(Up to 13 weeks)
- Percent of Participants With All-cause Allograft Failure During TP2(Up to 38 weeks)
- Number of Responders at the End-of-TP1(Up to 13 weeks)
- Number of Participants With All-cause Allograft Failure During TP2(Up to 38 weeks)
- The Rate of Change of eGFR During TP2 as Defined by the Slope of the Mean Regression of eGFR Over Time at End of TP2(Up to 38 weeks)
- Proportion of Subjects Surviving Through the Follow-up Period(Up to approximately 208 weeks)
- Time to Maximum Plasma Concentration (Tmax) for C1-INH Functional Activity(Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1)
- Area Under the Plasma Concentration Time Curve (AUC0-t) for C1-INH Functional Activity(Up to 72 hours after post-dose on Day 10 and on Day 77 of Period 1)
研究者
研究点 (26)
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