An Assessment of Humacyte's Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 76
- 主要终点
- Number of Participants With Loss of Secondary Patency
研究概览
简要总结
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
详细描述
This is a Phase 3, prospective, multicenter, multinational, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent would undergo study-specific screening assessments within 35 days from the day of informed consent.
Participants who consented were randomized to the HAV treatment arm of one of the two commercially available comparators.
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
- None
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
- •Subjects with ESRD who need placement of an AV graft in the arm.
- •Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
- •Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
- •Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days).
- •Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).
- •Adequate liver function prior to Day 0 (within 35 days).
- •Female subjects must be either:
- •Of non-childbearing potential Or
- •Must agree to use at least one form of birth control methods for the duration of the study.
- •Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
- •Life expectancy of at least 1 year.
排除标准
- •History or evidence of severe peripheral vascular disease in the intended arm for implantation.
- •Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation.
- •Treatment with any investigational drug or device within 60 days prior to study entry (Day 0).
- •Cancer that is actively being treated with a cytotoxic agent.
- •Documented hyper-coagulable state.
- •Bleeding diathesis.
- •Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
- •High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
- •Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
- •The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
- •tacrolimus or FK506 [Prograf]
- •mycophenolate mofetil [Cellcept],
- •cyclosporine [Sandimmune or Gengraf] i-Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
- •Anticipated renal transplant within 6 months.
- •Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
- •Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before implantation.
- •Known serious allergy to planned antiplatelet agent.
- •Pregnant women, or women intending to become pregnant during the course of the trial.
- •Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit.
- •Previous enrollment in this study or any other study with the HAV.
- •Employees of Humacyte and employees or relatives of the investigator.
研究组 & 干预措施
ePTFE
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)
干预措施: ePTFE graft (Device)
Human Acellular Vessel (HAV)
HAV-tissue-engineered vascular conduit (6mm diameter)
干预措施: Human Acellular Vessel (HAV) (Biological)
结局指标
主要结局
Number of Participants With Loss of Secondary Patency
时间窗: 24 months post-implantation
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Number of Participants With Loss of Secondary Patency
时间窗: 12 months post-implantation
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
Number of Participants With Loss of Secondary Patency
时间窗: 18 months post-implantation
1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).
次要结局
- Study Conduit Abandonment(60 months post-implantation)
- Rate of Adjudicated Study Conduit Access Related Infections(24 months post-implantation)
- Access-related Infections(60 months post-implantation)
- Participants With at Least 1 Intervention Required to Achieve/Maintain Secondary Patency(24 months post-implantation)
- Total Interventions Performed to Maintain Secondary Patency (Ballon Size Not > 6 Millimeters)(60 months post-implantation)
- Total Interventions Performed to Maintain Secondary Patency (Balloon Size > 6 Millimeters)(60 months post-implantation)
- Thrombosis of Study Access That Required Intervention(60 months post-implantation)
- Pseudoaneurysm Formation(60 months post-implantation)
- Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury(60 months post-implantation)
- Anastomotic Bleeding or Rupture(60 months post-implantation)
- Calculated Panel Reactive Antibody More Than 20% Change From Baseline(24 months post-implantation)
- Mean Inner Diameter of Conduit (Millimeter)(60 months post-implantation)
- Number of Participants With Loss of Primary Patency(60 months post-implantation)
- Dialysis Efficiency as Measured by spKt/Vurea (Subset of Subjects)(2 to 18 Months post-implantation)
- Severity of Adverse Events(24 months post-implantation)
- Number of Participants With at Least One Adverse Event(24 months post-implantation)
- True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)(60 months post-implantation)
- Number of Participants With Loss of Primary Patency(12 months post-implantation)
- Number of Participants With Loss of Primary Patency(18 months post-implantation)
- Number of Participants With Loss of Primary Patency(24 months post-implantation)
- Study Conduit Abandonment(24 months post-implantation)
- Thrombosis of Study Access That Required Intervention(24 months post-implantation)
- True Aneurysm Formation (Conduit Lumen Diameter >9 Millimeters)(24 months post-implantation)
- Pseudoaneurysm Formation(24 months post-implantation)
- Study Conduit Spontaneous Ruptures Due to Iatrogenic Injury(24 months post-implantation)
- Anastomotic Bleeding or Rupture(24 months post-implantation)
- Calculated Panel Reactive Antibody More Than 20% Change From Baseline(18 months post-implantation)
- Mean Inner Diameter of Conduit (Millimeter)(12 months post-implantation)
- Mean Inner Diameter of Conduit (Millimeter)(24 months post-implantation)