NCT04527328已完成不适用
A Randomized, Double-Blind, Phase 2a Study to Evaluate the Tolerability, Feasibility, and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment Associated With End-Stage Renal Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity
研究概览
简要总结
This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.
详细描述
In this study, approximately 26 men and women on dialysis due to end stage renal disease and who have cognitive impairment will be randomly assigned to receive AKST1210 or control during each hemodialysis session for 3 months. The primary objective is to assess the safety and tolerability of AKST1210, and secondary objectives include changes in cognitive assessments as well as the feasibility of using AKST1210 in this setting.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On chronic hemodialysis due to end-stage renal disease for ≥ 12 months.
- •Score on the Montreal Cognitive Assessment (MoCA) ≥ 16 and ≤
- •Body mass index (BMI) ≥ 20 and ≤
- •The subject must be able to follow the study protocol, receive the treatment in the established timeframe, and continue during the follow-up interval.
- •The subject must have sufficient visual and auditory acuity to reliably complete all study assessments.
- •Provided a signed and dated informed consent form.
排除标准
- •Subjects for whom adequate anticoagulation cannot be achieved. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is allowed.
- •History of hypersensitivity to heparin.
- •Pregnant or breast-feeding women or women who are planning to become pregnant.
- •Clinically significant abnormalities on Screening ECG including QT interval corrected for heart rate (QTc) (using Fridericia's correction formula) of ≥ 500 ms in men and ≥ 520 ms in women.
- •Clinically significant and unexpected abnormalities in this patient population in complete blood count, complete metabolic panel, coagulation, and thyroid stimulating hormone (TSH).
- •Subjects with a hemoglobin level < 9.0 g/dL.
- •Concurrent or recent participation in another investigational clinical trial. Prior clinical trial subjects must have discontinued investigational agents at least 30 days prior to Screening.
- •Subjects planning to receive renal transplantation during the study.
- •Any other condition and/or situation that the investigator believes may interfere with the safety of the subject, study conduct, or interpretation of study data.
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events Assessed by Intensity
时间窗: Baseline to Week 14
Number of participants with Treatment-Emergent Adverse Events (TEAE) assessed by Intensity (mild, moderate, or severe) coded by the Medical Dictionary for Regulatory Activities (MedDRA)
次要结局
- Tolerability as Measured by the Number of Subjects Who Complete Each Treatment Period(Baseline to Week 12)
- Change From Baseline in Sleep Quality Per the Pittsburgh Sleep Quality Index (PSQI)(Baseline to Week 12)
- Number of Participants Who Discontinued Due to Intradialytic Hypotension (IDH)(Baseline to Week 12)
- Change From Baseline in Quality of Life Per the Short-Form Health Survey (SF-36)(Baseline to Week 12)
- Change From Baseline in Fatigue Per the Fatigue Questionnaire - Functional Assessments of Chronic Illness Therapy (FACIT)(Baseline to Week 12)
- Tolerability as Measured by the Number of Subjects Who Complete the Run-In Period.(Week -2 (Day -14) to Week -1 (Day -1))
- Tolerability as Measured by the Percentage of Subjects Who Completed All Visits.(Baseline to Week 14)
- Change From Baseline in Montreal Cognitive Assessment (MoCA)(Screening to Week 14)
- Tolerability as Measured by the Percentage of Subjects Who Complete Each Treatment Period(Baseline to Week 12)
- Tolerability as Measured by the Percentage of Subjects Who Complete the Run-in Period(Week -2 (Day -14) to Week -1 (Day -1))
- Tolerability as Measured by the Number of Subjects Who Completed All Visits.(Baseline to Week 14)
- Change From Baseline in Computer-based Cognitive Assessment (CogState) Composite Score(Baseline to Week 12)
- Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9)(Baseline to Week 14)
- Number of Participants Who Discontinued Due to Anemia.(Baseline to Week 12)
研究者
研究点 (8)
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