NCT02474667Unknown3 期
A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (Formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 253
- 试验地点
- 30
- 主要终点
- The severity of DGF
研究概览
简要总结
The major objective is to demonstrate the safety and efficacy of ANG-3777 in improving graft function and reducing the severity of delayed graft function (DGF) in recipients at high risk of DGF after receiving a deceased donor renal allograft.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
- •Males and females ≥ 18 years of age.
- •Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
- •Patient is to be the recipient of a first kidney transplant from a deceased donor.
- •Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
- •Body mass index < 40 based on dry weight. Dry weight and height parameters obtained within 7 days prior to study entry may be used..
- •Estimated donor organ cold ischemia time less than 30 hours (for PMP kidneys less than 40 hours).
- •Exclusion Criteria
- •Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
- •Recipient of an ABO-incompatible kidney.
- •Recipient of pediatric en-bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
- •Recipient of a kidney preserved by normothermic pulsatile machine perfusion.
- •Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
- •Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation.
- •Concurrent sepsis or active bacterial infection.
- •Has an active malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
排除标准
- 未提供
研究组 & 干预措施
BB3
Active Comparator
Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
干预措施: ANG-3777 (Drug)
Normal Saline
Placebo Comparator
Administered IV for 30 min within 24 hours after transplantation and around 24 hours after previous dosing 3 days in a row
干预措施: Placebo (Other)
结局指标
主要结局
The severity of DGF
时间窗: Day 360
The primary endpoint is renal function assessed by eGFR (using the CKD-EPI equation based on serum creatinine), with a primary analysis time point consisting of eGFR at month 12.
次要结局
未报告次要终点
研究者
研究点 (30)
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