CTRI/2021/12/038373招募中1 期
A Phase I clinical study of locally administered AntiPlatelet, AntiCoagulant (APAC) at the time ofvascular surgery to create a radiocephalic arterio-venous fistula (RCAVF) in patients withchronic kidney disease (CKD) to facilitate hemodialysis access.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Determination of the highest safe dose by evaluating the safety and tolerability of of APAC during AVF creation in patients with CKD
研究概览
简要总结
A Phase I, prospective, open label, dose finding, First in Human clinical study to assess the safety and tolerability of either single (1 ml rinse pre surgery + 2 ml post surgery) dose APAC or control treatment at the time of RCAVF creation in 30 CKD patients (10 in each cohort) undergoing AVF creation to facilitate hemodialysis. Total 3 dose levels of APAC will be evaluated and patients participation duration will be of 4 week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Dialysis naïve patients with CKD stages 4 and 5 (defined as an eGFR less than 30 mL/min/1.73m2), ≥18 and <65 years of age of either gender, requiring hemodialysis access surgery.
- •2.Patient eligible to undergo AVF surgery as determined by the nephrologist and surgeon.
- •3.Patients with appropriate vessel diameters: a radial artery and a cephalic vein diameter ≥ 2 mm (inner-to-inner diameter), measured via duplex ultrasound.
- •4.Venous patency in the draining vein with no stenosis or thrombosis, with visible, palpable, and compressible (thrombus free) vein.
- •5.Life expectancy of at least 12 months and not likely to require kidney transplantation within 3 months of administration of study medication.
- •6.Patients able to provide written informed consent and willing to follow all study requirements.
排除标准
- •1.Patients already receiving hemodialysis or who have previously undergone dialysis, successful or otherwise.
- •2.Existing AVF at any anatomical site.
- •3.Patients in whom the intended site for surgical intervention is the only potential site for an AVF.
- •4.Patients taking a contraindicated medication which will interfere with the study outcome.
- •5.Patients receiving warfarin, unfractionated heparin, LMWH or any other systemic anticoagulant, such as direct oral anticoagulants at Screening 6.Patients who are taking or who have taken antiplatelet agents during 30 days prior to Screening, excluding aspirin.
- •7.Patients with a history of known sensitivity to heparin or aspirin.
- •8.Patients with APTT i.e., ≥1.5-fold prolongation, PT >1.5 of ULN, LFT >2.5 of ULN, Hb <7 g/dL 9.Patients with a history of myocardial infarction, stroke, peripheral arterial occlusive disease, angioplasty, previous venous thromboembolism, transient ischemic attack (TIA).
- •10.Patients with known medical history of nephrotic syndrome, arterial aneurysm, heparin-induced thrombocytopenia, inherited or acquired thrombophilic condition or symptoms of fever or active infection or any other medical condition or underlying cause for their CKD.
- •11.Patients demonstrating an absence of radial and/or ulnar arterial blood flow or non-patent palmer arch, as determined via a modified Allen test at Screening.
- •12.Patients with any systemic condition (as noted in their medical history at Screening) known to be associated with impaired hemostasis e.g., hemophilia, Von Willebrand’s disease or other bleeding disorders.
- •13.Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study.
- •14.Female patients who are pregnant, lactating or of childbearing potential and unwilling or unable to use adequate contraception 15.Patients who for any reason, in the investigator’s opinion, are unsuitable for enrolment into the study.
结局指标
主要结局
Determination of the highest safe dose by evaluating the safety and tolerability of of APAC during AVF creation in patients with CKD
时间窗: During the first 24-hours post-the AVF surgery and administration of APAC
次要结局
- Determination of AVF maturation rate, functional AVF patency rate and AVF failure rate(At Week 4 following surgery)
- To establish the safety and tolerability profile of APAC(During the 4 weeks post-surgery and treatment)
- To determine a Recommended Phase 2 Dose(s) (RP2D)(During 4 weeks post-surgery and treatment)
研究者
研究点 (6)
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