Premarket Clinical Safety Assessment of the ELISIO™-HX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in serum level of albumin
研究概览
简要总结
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational dialyzer.
The primary efficacy objective is to evaluate the performance of the use of the high permeability hemodialyzer series ELISIO™-HX, by showing that the clearance rate of middle molecular weight lambda (λ) free light chain (FLC) is improved by using the investigational dialyzer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •End stage renal disease patients on hemodialysis age 22 and older, or between ages 18 and 21 with a weight ≥40 kg.
- •Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing.
- •Hemodialysis therapy with the ELISIO-H dialyzer for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months.
- •Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m
- •Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.
- •Able to give informed consent after an explanation of the proposed study, and willing to comply with the study requirements for therapy during the entire study treatment period.
- •Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter). Stable access should be confirmed by:
- •Kt/V ≥1.2 for past 2 measurements, and/or
- •Achievement of within 15% the prescribed blood flow rate (≥350 ml/min) over 3 treatments prior to study entry Note: must have a flow of ≥350 ml/min at the time of enrollment.
- •Participants who have given their informed consent in writing.
排除标准
- •Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female participants of childbearing potential, defined as a woman <55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Participants of childbearing potential must use a medically acceptable means of contraception during their participation in the study.
- •Have chronic liver disease.
- •Have a known paraprotein-associated disease.
- •Have known bleeding disorders (e.g., gastrointestinal bleeding, colonic polyps, small bowel angiodysplasia, and active peptic ulcers).
- •Have had a major bleeding episode (e.g., soft tissue bleeding, blood in stool, prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤12 weeks prior to enrolling.
- •Have had a blood (red blood cell) transfusion ≤12 weeks prior to enrollment.
- •Have had an acute infection ≤4 weeks prior to enrollment.
- •Have active cancer, except for basal cell or squamous cell skin cancer.
- •Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1
- •Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia).
- •Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition).
- •Have a positive serology test for human immunodeficiency virus or hepatitis infection.
- •Have a significant psychiatric disorder or mental disability.
- •Are scheduled for planned interventions requiring hospitalization >1 week.
- •Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to peritoneal dialysis (PD) therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located.
- •Are currently participating in another interventional clinical study or have participated in another interventional clinical study in the past 3 months.
- •Have a history of non-compliance with HD as assessed by an investigator.
- •Have had a major cardiovascular or cerebrovascular event within 3 months of enrollment.
- •Have a history with consistent evidence of intradialytic hypotension.
- •Have uncontrolled (systolic BP > 180 mmHg) hypertension.
- •Have had adverse reactions to dialyzer materials
- •Vulnerable participant populations (e.g., incarcerated or cognitively challenged adults)
研究组 & 干预措施
ELISIO™-HX Dialyzer
The ELISIO™-HX is a single use novel medium cut-off dialyzer that is intended for use as an artificial kidney for the treatment of participants with renal failure.
干预措施: ELISIO™-HX Dialyzer (Device)
结局指标
主要结局
Change in serum level of albumin
时间窗: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
Reduction ratio (RR) of lambda (λ) FLC
时间窗: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
Change in Serum Level of Albumin
时间窗: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
Reduction Ratio (RR) of Lambda (λ) FLC
时间窗: Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks of treatment with ELISIO-HX
RR (%) is derived as (\[post-baseline value - baseline value\] / baseline value) x 100. A negative mean RR indicates increased removal of λ FLC after treatment compared to baseline.
次要结局
- Change in Factor VII(Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks)
- Change in Protein C(Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks)
- Change in Factor II(Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks)
- Change in Vitamin A(Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks)
- Change in nPNA(nPCR) [normalized Protein equivalent of Nitrogen Appearance (normalized Protein Catabolic Rate)](Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks)
- Change in nPNA(nPCR) [Normalized Protein Equivalent of Nitrogen Appearance (Normalized Protein Catabolic Rate)](Baseline (last blood draw post-dialysis with ELISIO-H) to last blood draw post-dialysis after 12 weeks)