NCT04511338已完成不适用
A Randomized, Open Label, Cross-over Feasibility Study for Heparin-free Hemodialysis With the Dialyzer With Endexo™ in End-Stage Renal Disease (ESRD) Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit.
研究概览
简要总结
This study will assess the safety and efficacy of heparin free hemodialysis (HD) performed with dialyzers with Endexo in adult end-stage renal disease (ESRD) subjects on thrice-weekly in-center HD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be an adult, defined as having had a 22nd birthday on or before the date of signed informed consent
- •Has been prescribed in center thrice weekly HD for at least 180 days prior to the date of signed informed consent
- •Has been on Conventional HD for at least 30 days prior to the date of signed informed consent. Conventional HD includes: Optiflux dialyzer (F160NR or F180NR), standard of care (SOC) bloodline, Citrasate dialysate, and regularly prescribed heparin dose.
- •Has a prescribed HD treatment duration ≥ 180 minutes (3 hours) and ≤ 270 minutes (4.5 hours) at the time of signed informed consent
- •Has a well-established functional permanent vascular access (AVF, AVG) that can allow a blood flow of at least 250 mL/min
- •Has been on a regularly prescribed heparin dose for HD and has had no change in heparin prescription within 14 days prior to the date of signed informed consent
- •Has the following most recently available laboratory results within 45 days prior to the date of signed informed consent:
- •Single pool Kt/V (spKt/V) ≥ 1.2
- •Hemoglobin ≥ 9 g/dL
- •Platelet count ≥ 100,000/mm3
- •A female of childbearing potential must have a negative serum pregnancy test at the time of screening and agree to use an acceptable method of contraception during the study
排除标准
- •Known allergic reactions to Endexo
- •Known heparin contraindications
- •Hospitalization within 30 days prior to the date of signed informed consent
- •Presence of active malignancy, congestive heart failure New York Heart Association (NYHA) Class III or IV (see Appendix II. A New York Heart Association Functional Classification), or liver cirrhosis
- •Is receiving or has received chemotherapy/radiation therapy/immunotherapy/plasmapheresis therapy within 90 days prior to the date of signed informed consent
- •Is receiving oral or/and intravenous (IV) antibiotics or has used oral or/and IV antibiotics within 14 days prior to the date of signed informed consent
- •Is currently enrolled in or has completed any other investigational product study within 30 days prior to the date of signed informed consent
- •Is receiving anticoagulants including vitamin K antagonists
- •Is receiving a glycoprotein platelet inhibitor
- •Is receiving more than one anti-platelet medication
- •Is receiving systemic heparin therapy for prevention or treatment besides heparin prescribed for dialysis
- •Requiring blood and other labile blood products (for e.g., fresh frozen plasma, platelets) transfusion during HD treatments
- •Has history of clotting or bleeding disorders
- •Has history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's ability to follow the requirements of the study and participate for the full duration of the study, or is not in the best interest of the subjects to participate, in the opinion of the investigator.
结局指标
主要结局
The Primary Endpoint is the Number and Percent (%) of Successful Heparin-free HD Sessions for Each Subject in Each Circuit.
时间窗: Approximately 5 weeks, Period 1: two weeks with either Circuit A or Circuit B; Washout: 1 week; Period 2: two weeks with the circuit other than Period 1.
Each participant was expected to receive 3 heparin-free HD sessions. The number and percentage of successful HD sessions were derived based on the 3 heparin-free HD sessions for each participant in each circuit. A successful HD session must meet all the following criteria: 1. Absence of complete HD circuit occlusion (Grade 4) rendering dialysis impossible 2. Absence of the need to replace dialyzers or bloodlines due to clotting 3. Absence of saline flushes to maintain blood flow through the circuit during the HD session 4. Absence of any additional heparin beyond what is allowed per study visits 5. Single pool Kt/V (spKt/V) ≥ 1.2
次要结局
- The Secondary Endpoints Include Device-related Adverse Events.(two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2))
- The Secondary Endpoints Include Adverse Events .(two weeks each period (10 weeks per subject: 4 weeks for screening, 2 weeks for Period 1, 1 week for Washout, and 2 weeks for Period 2))
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
3 期
Hemodialysis Without Anticoagulation in Intensive Care UnitKidney FailureCritically IllHemorrhageNCT00242398Centre Hospitalier Départemental120
已完成
4 期
HepZero study: Heparin Free dialysis with Evodial: A prospective multicenter, open, randomized, controlled clinical study with parallel groupsChronic end-stage renal disease'renal failure' - 'chronic end-stage renal disease'NL-OMON36007Gambro Lundia AB26
已完成
不适用
HepZero:Heparin Free Dialysis With EvodialPatients Requiring Heparin Free Dialysis TreatmentsChronic Kidney DiseaseNCT01318486Vantive Health LLC265
已完成
2 期
Anemia Study in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Blood Pressure (ASCEND-BP)AnaemiaNCT03029247GlaxoSmithKline105
Unknown
不适用
Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-HemodiafiltrationChronic Kidney Disease Requiring Chronic DialysisNCT03714386Fundación Senefro700