NCT02610296已完成3 期
A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant
Quark Pharmaceuticals84 个研究点 分布在 5 个国家目标入组 594 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 594
- 试验地点
- 84
- 主要终点
- The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
研究概览
简要总结
The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).
详细描述
This is a Phase 3 randomized, placebo-controlled, double-blind, multi-center trial stratified by donor age and by region to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from DBD donors who were at least 45 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Has the ability to understand the requirements of the study, is able to provide written informed consent and is willing and able to comply with the requirements of the study protocol.
- •Male or female at least 18 years of age.
- •Has dialysis dependent renal failure initiated at least 2 months prior to transplantation.
- •Is to be a recipient of a transplant from a deceased donor (brain death criteria) ≥ 45 years of age.
- •Based on donor age, the following requirements for the risk of DGF (determined using the Irish DGF risk assessment nomogram) and cold ischemia time (CIT) must be met:
- •Donor age 45 - 59 years: estimated DGF risk ≥ 20% and estimated CIT ≥ 10 hour
- •Donor age ≥ 60 years: no minimum estimated DGF risk or minimum estimated CIT
- •Is able to comply with the requirement of antibody induction therapy with rabbit polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per center standard of care.
- •Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.
排除标准
- •Recipient of a live donor kidney or a kidney from a donation after cardiac death (DCD) donor.
- •Recipient of donor kidney preserved with normothermic machine perfusion.
- •Scheduled to undergo multiorgan transplantation.
- •Has a planned transplant of kidneys that are implanted en bloc (dual kidney transplant).
- •Has planned transplant of dual kidneys (from the same donor) transplanted not en bloc.
- •Has lost first kidney transplant due to graft thrombosis.
- •Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
- •Is scheduled to receive an ABO-incompatible donor kidney.
- •Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC crossmatch method, if performed.
- •Has a positive T- or B-cell flow cross-match AND donor specific anti-HLA antibody (DSA) detected by flow cytometry, Luminex® based antigen-specific anti-HLA antibody testing, or by similar methodology, if performed.
- •Has undergone desensitization to remove donor specific anti-HLA antibodies prior to transplantation.
- •Has participated in an investigational study within the last 30 days or received an investigational product within 5 half-lives of the study drug administration, whichever is longest.
- •Has known allergy to or has participated in a prior study with siRNA.
- •Has a history of HBV (Note: subjects with a serological profile suggestive of clearance, or prior antiviral treatment of a prior HBV infection, may be enrolled with the approval of the Medical Monitor).
- •Has a history of HIV.
- •Recipient of a known HIV positive donor kidney.
- •Is HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an approved antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled. Subjects who have been cleared of HCV virus after treatment with an unapproved regimen should be approved by the Medical Monitor).
研究组 & 干预措施
QPI-1002
Active Comparator
QPI-1002 Injection, single dose
干预措施: QPI-1002 (Drug)
Placebo
Placebo Comparator
isotonic saline
干预措施: Placebo (Other)
结局指标
主要结局
The number of dialysis sessions through Day 30 for subjects who started dialysis beginning in the first 7 days post-transplant.
时间窗: Day 0 to Day 30
次要结局
- The proportion of subjects with a decrease in serum creatinine of ≥ 10% on three consecutive days in the first 7 days post-transplant.(Day 0 to Day 7)
- The proportion of subjects requiring dialysis for any reason in the first 7 days post-transplant.(Day 0 to Day 7)
研究者
研究点 (84)
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