Department of Nephrology, Sun Yat-sen University First Affiliated Hospital，National Health Commission Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, Guangdong, China.
Department of Medical Statistics, Clinical Trials Unit, Sun Yat-sen University First Affiliated Hospital, Guangzhou, Guangdong, China.
BMJ Open. 2020 Oct 10;10(10):e037842. doi: 10.1136/bmjopen-2020-037842.
The prevalence of hyperuricaemia in peritoneal dialysis patients is quite high. Studies have demonstrated a correlation between hyperuricaemia and cardiovascular disease and treatment of hyperuricaemia reportedly reduces cardiovascular risk in patients with chronic kidney disease. However, whether hyperuricaemia treatment benefits cardiovascular outcomes in continuous ambulatory peritoneal dialysis (CAPD) patients is not yet known.
This prospective, multicentre, double-blind, randomised controlled trial was designed to evaluate the effects of hyperuricaemia treatment on cardiovascular event risk in CAPD patients. Based on a power of 80%, with type I error α=0.05, two-sided test and 1:1 parallel control study, considering a dropout rate of 20%, a total of 548 eligible patients are expected to be randomly assigned to either the hyperuricaemia treatment group (febuxostat) or control group (placebo).
This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital, Sun Yat-sen University and the ethics committees of other participating institutions. Written informed consent will be obtained from potential trial participants or authorised surrogates.The findings of the study will be disseminated through publications in peer-reviewed journals, and presentations at national and international conferences.
NCT03200210. 25 June 2017. The trial was started on 13 July 2017, and is expected to end by 31 December 2022. Till 20 Jan 2020, a total of 548 patients have been recruited.
The protocol version number and date are YLT-1604-V2.0 and 15 December 2016.
腹膜透析患者高尿酸血症的患病率相当高。研究表明，高尿酸血症与心血管疾病之间存在相关性，且高尿酸血症的治疗据称可降低慢性肾脏病患者的心血管风险。然而，高尿酸血症的治疗是否有益于持续性不卧床腹膜透析（CAPD）患者的心血管结局尚不清楚。
本前瞻性、多中心、双盲、随机对照试验旨在评估高尿酸血症治疗对 CAPD 患者心血管事件风险的影响。根据 80%的效力、I 型错误α=0.05、双侧检验和 1:1 平行对照研究，考虑到 20%的脱落率，预计将有 548 名符合条件的患者被随机分配到高尿酸血症治疗组（非布司他）或对照组（安慰剂）。
本研究已获得中山大学第一附属医院医学伦理委员会和其他参与机构伦理委员会的批准。将从潜在的试验参与者或授权代理人那里获得书面知情同意。研究结果将通过发表在同行评议期刊上以及在国内外会议上的演讲来传播。
NCT03200210。2017 年 6 月 25 日。试验于 2017 年 7 月 13 日开始，预计于 2022 年 12 月 31 日结束。截至 2020 年 1 月 20 日，共招募了 548 名患者。
方案版本号和日期为 YLT-1604-V2.0 和 2016 年 12 月 15 日。
