A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus Eluting Collagen Implant (The ACCESS 2 Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 21
- 主要终点
- Clinical Fistula Maturation (FM)
研究概览
简要总结
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
详细描述
This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant.
Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Currently on hemodialysis for ≤12 months
- •Successful creation of a single stage radiocephalic end to side fistula
排除标准
- •Prior AV access created on the limb where the fistula surgery is planned
- •Planned start of peritoneal dialysis within 6 months of randomization
- •Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- •Known to be HIV positive
- •Prisoner, mentally incompetent, and/or current alcohol or drug abuser
研究组 & 干预措施
Treatment Arm
Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).
干预措施: Sirolimus (Drug)
结局指标
主要结局
Clinical Fistula Maturation (FM)
时间窗: 6 Months
Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is \<300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization. The primary endpoint will be summarized as a time-to-event endpoint for the SeCI (Sirogen) and control groups by reporting the cumulative proportion of AVF that achieve FM over time \[defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)\].
次要结局
- Fistula Suitability for Dialysis at 12 months (FSD12)(1 year)
- Secondary Patency (SP)(1 year)
- Time To First Dialysis (TTFD)(1 year)
- Mature Fistula with Preserved Function at 12 Months (MFPF)(1 year)
- Durable Fistula Maturation (DFM)(1 year)
- Cumulative Fistula Use (CFU)(1 year)
- Cumulative Catheter Exposure (CCE)(1 year)