CTRI/2019/03/018081尚未招募2 期
Pivotal phase-2 trials of the first Indian hemodialysis device with a telenephrology based rural care delivery model
Renalyx Health Systems Pvt Ltd1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年6月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and Efficacy of device
研究概览
简要总结
This is a prospective study, open labelled, controlled crossover interventional study designed to provide the phase-2 trial data of the first Indian hemodialysis device (RxT17). One hundred and thirty sessions of hemodialysis involving stable chronic kidney disease (CKD) stage -V subjects, receiving regular intermittent hemodialysis (HD) treatment via an arteriovenous fistula as vascular access, will be studied. The RxT17 device is intended to potentially respond to the unmet public health needs of the rural Indian CKD-V patients. The patients will also be monitored using a remote care delivery model in addition to the conventional care using the Fresenius 4008S machine for comparision of primary outcomes. It is expected to improve outcomes, reduce costs and provide treatment access to patients with end stage renal disease (ESRD), especially in rural India and developing world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing and competent to sign the approved informed consent.
- •Patient must be at least 21 years of age or older.
- •Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 2 times a week for at least 3 months prior to being enrolled.
- •Vascular access must be through a functioning arteriovenous fistula (AVF) with no thrombolytic therapy or clotting of the AVF within the past 4 weeks.
- •Willing to comply with the requirements of experimental treatment with the follow-up after 24 hours.
- •Expected survival of no less than 6 months.
- •Consent to allow review of their medical records by the investigators, and monitors.
- •Hemoglobin level ≥ 8.0 g/dL prior to hemodialysis treatment.
排除标准
- •Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.
- •History (within the 12 weeks prior to the study) of cardiovascular events including.
- •Unstable angina Myocardial Infarction Stroke Clinical Significant Arrhythmia.
- •Life threatening arrhythmia within the past 30 days.
- •Severe intra-dialytic hypotension within the last 30 days.
- •Shock within the last 30 days.
- •Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient.
- •Seizure disorder requiring active treatment for a seizure episode during the last 6 months.
- •Major Surgery (excluding vascular access surgery) within the past 30 days.
- •Currently receiving intravenous antibiotic therapy for systemic infection.
- •Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days.
- •Active bleeding.
- •Hematological disease (e.g. malignancies, hemolytic anemia, thrombocytopenia), and other conditions that may interfere with data.
- •Current enrollment in another investigational device or drug trial.
- •Subject is pregnant (e.g., positive HCG test) or is breast-feeding.
- •Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.
- •Allergy to heparin or ethylene oxide.
- •Hypertension deemed uncontrolled, at the discretion of the investigator, within the past 30 days.
- •Has an implantable electronic device (e.g. pacemaker).
- •Has no positive viral serology.
结局指标
主要结局
Safety and Efficacy of device
时间窗: 4 hours per session
次要结局
- Effectiveness of remote monitoring(Costs (direct and indirect))
研究者
研究点 (1)
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