EUCTR2015-000726-11-ES进行中（未招募）1 期
A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of Cinryze® (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection in kidney transplant patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
入选标准
- •To be eligible for this protocol, a subject must:
- •- Be >=18 years of age.
- •- Weigh >= 40 kg.
- •- Have had human leukocyte antigen (HLA) DSA identified at the time of diagnosis of AMR.
- •- Have a first episode of AMR (qualifying episode) in the subject´s current renal allograft within 12 months after transplant defined by a renal allograft biopsy demonstrating neutrophil and/or monocyte infiltration in the peritubular capillaries and/or glomeruli with or without evidence of C4d by immunohistopathology.
- •- Have received a kidney transplant for which the qualifying episode of AMR was diagnosed and achieved an eGFR >=40 mL/minute within 3 months post-transplant as estimated by the MDRD formula.
- •- Be able to receive first dose of study drug within 72 hours after the (qualifying) renal allograft biopsy that was diagnostic for AMR.
- •- Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
- •- Subject, who is female, must have a negative urine pregnancy test confirmed by a negative serum beta human chorionic gonadotropin pregnancy test at the Screening Visit and must have a negative urine pregnancy test at the Day 1 visit, and agree to comply with any applicable contraceptive requirements of the protocol.
- •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 112
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are excluded from the study if any of the following exclusion criteria are met:
- •- Have received pediatric en bloc kidney transplant.
- •- Have focal sclerosing glomerulosclerosis, rapidly progressive glomerulonephritis, membrano proliferative glomerulonephritis type 1, or dense deposit disease as the cause of native kidney failure.
- •- Have, as determined by the investigator and/or medical monitor, any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results, including (as determined by the transplanting surgeon and documented in the operative report) any major technical complications of the renal artery, renal vein, or ureteral anastomosis.
- •- Have any ongoing infection that causes hemodynamic compromise.
- •- Have a history of abnormal bleeding, clotting, or any coagulopathy (excluding a history of clotted hemodialysis access or superficial thrombophlebitis in the absence of medically confirmed coagulopathy).
- •- Have a history of allergic reaction to Cinryze or other blood products.
- •- Have participated in the active dosing phase of any other investigational drug study within 30 days prior to dosing with study drug.
- •- Have any of the following laboratory values within 48 hours prior to dosing with study drug:
- •-- White blood cell count <0.5×109/L or >20×109/L
- •-- Platelet count <25×109/L or >600×109/L
- •- Be pregnant or breastfeeding.
- •-Have received any of the following agents within 1 month prior to the first dose of study drug:
- •-- Any C1 INH (plasma-derived [eg, Cinryze®, Berinert®, Cetor®] or recombinant [eg, Rhucin®])
- •-- Eculizumab (Soliris®)
- •-- Ecallantide (Kalbitor®)
- •-- Bortezomib (Velcade®)
研究者
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