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基于尿外泌体蛋白质组学研究羟氯喹促进早期高尿酸血症患者肾脏尿酸排泄和改善肾损伤易感性的作用
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注册号:

Registration number:

ChiCTR2000035495 

最近更新日期:

Date of Last Refreshed on:

2020-08-12 

注册时间:

Date of Registration:

2020-08-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于尿外泌体蛋白质组学研究羟氯喹促进早期高尿酸血症患者肾脏尿酸排泄和改善肾损伤易感性的作用 

Public title:

Effect of hydroxychloroquine on renal uric acid excretion in patients with early hyperuricemia based on urinary exosomes proteomics 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于尿外泌体蛋白质组学研究羟氯喹促进早期高尿酸血症患者肾脏尿酸排泄和改善肾损伤易感性的作用 

Scientific title:

Effect of hydroxychloroquine on renal uric acid excretion in patients with early hyperuricemia based on urinary exosomes proteomics 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

肖婧 

研究负责人:

肖婧 

Applicant:

Xiao Jing 

Study leader:

Xiao Jing 

申请注册联系人电话:

Applicant telephone:

+86 13817100256 

研究负责人电话:

Study leader's telephone:

+86 13817100256 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

jingxiao13@fudan.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

jingxiao13@fudan.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市延安西路221号华东医院6号楼10楼肾内科 

研究负责人通讯地址:

上海市延安西路221号华东医院6号楼10楼肾内科 

Applicant address:

221 West Yan'an Road, Jin'an District, Shanghai, China 

Study leader's address:

221 West Yan'an Road, Jin'an District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

复旦大学附属华东医院肾内科 

Applicant's institution:

Huadong Hospital Affiliated to Fudan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2020K118 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

复旦大学附属华东医院伦理审查委员会 

Name of the ethic committee:

Ethical committe of Huadong hospital affliatted to Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-11 

伦理委员会联系人:

沙颖豪 

Contact Name of the ethic committee:

Dr. SHA Yinghao 

伦理委员会联系地址:

上海市延安西路318号复旦大学附属华东医院伦理办公室 

Contact Address of the ethic committee:

318 West Yan'an Road, Ethical office of Huadong hospital affiliated to Fudan University 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-62483180-720322 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

hdyyll@126.com 

研究实施负责(组长)单位:

复旦大学附属华东医院 

Primary sponsor:

Huadong Hospital Affiliated to Fudan University 

研究实施负责(组长)单位地址:

上海市延安西路221号华东医院6号楼10楼肾内科 

Primary sponsor's address:

221 West Yan'an Road, Jin'an District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华东医院

具体地址:

上海市延安西路221号华东医院6号楼10楼肾内科

Institution
hospital:

Huadong Hospital Affiliated to Fudan University

Address:

221 West Yan'an Road, Jin'an District

经费或物资来源:

上海申康医院发展中心促进市级医院临床技能与临床创新三年行动计划(2020-2022年)重大临床研究项目 

Source(s) of funding:

Major clinical research projects of Shanghai Shenkang hospital development center to promote clinical skills and clinical innovation of municipal hospitals (2020-2022) 

研究疾病:

高尿酸血症 

Target disease:

Hyperuricemia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

在早期(发病2年内)男性肾脏排泄不良型的原发性高尿酸血症患者中进行随机对照平行双盲试验,应用羟氯喹治疗6月(4-5mg/kg/d),与安慰剂对照,评估疗效(尿尿酸排泄、血尿酸和血羟氯喹代谢产物水平)和安全性(肝肾功能,血尿常规,心电图),以及尿外泌体蛋白质组学差异,评估其对肾损伤易感性的改善作用。 

Objectives of Study:

A randomized controlled, parallel, double-blind trial will be conducted in male patients with primary hyperuricemia with renal under excretion in the early stage (within 2 years of onset). Hydroxychloroquine will be used for 6 months (4-5 mg /kg/d) and compared with placebo to evaluate the efficacy (urinary urate excretion, serum uric acid and serum hydroxychloroquine metabolite levels) and safety (liver and kidney function, routine blood test and urinalysis, electrocardiogram), and urinary exosome proteomics differences to evaluate the improvement of hydroxychloroquine on renal susceptibility to hyperuricemia injury. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)了解试验全过程,自愿参加并签署知情同意书 (2)年龄18~75岁,男性; (3)患者在停止高嘌呤、高蛋白饮食2周或停用降尿酸药物2周后,非同日2次空腹血尿酸测定:420μmol/L(7mg/dL)~ 540μmol/L(9mg/dL); (4)无症状的高尿酸血症患者,未出现过痛风性关节炎、痛风石、尿酸性肾结石等痛风临床表现,且病程在2年内; (5)能够理解和配合研究相关内容。 

Inclusion criteria

(1) Understand the whole process of the experiment and sign the informed consent; (2) The age ranged from 18 to 75 years old, male; (3) After stopping high purine and high protein diet for 2 weeks or antiuricemic drugs for 2 weeks, fasting blood uric acid was measured twice on different days: 420 umol/L (7Mg / dl) 540 umol/L (9mg/dl); (4) Asymptomatic hyperuricemia patients had no gout arthritis, gout stone, uric acid kidney stone and other gout clinical manifestations, and the course of disease was within 2 years; (5) Be able to understand and cooperate with relevant research contents. 

排除标准:

(1)继发性高尿酸血症患者,如白血病、骨髓瘤、肾衰、多囊肾、某些内分泌疾病、某些药物如利尿剂、阿司匹林、抗结核药等引起的高尿酸; (2)合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病; (3)患急性和或慢性传染性疾病者; (4)过敏体质或对本药成分过敏者,体质虚弱者; (5)不符合纳入标准,未按规定用药、完成治疗,无法判断疗效或资料不全等影响疗效或安全性判断者; (6)患恶性肿瘤者; (7)心电图检查严重心律失常者; (8)有精神疾患,酗酒史,药物或其他物品滥用者; (9)筛查时平均坐位收缩压(SBP)≥140mmHg,平均坐位舒张压(DBP)≥90mmHg,或导入观察期平均坐位收缩压(SBP)≥160mmHg,平均坐位舒张压(DBP)≥100mmHg; (10)临床诊断射血分数降低的心力衰竭(HfrEF),且在导入观察其有持续临床症状; (11)在导入观察期前半年内出现脑卒中、短暂性脑缺血发作、急性冠脉综合征或需住院治疗的心脏衰竭恶化; (12)先天性或获得性孤立肾; (13)随机化前3月参与其他临床试验; (14)受试者血白细胞<3.0×10^9/L,或有明确的贫血(血红蛋白小于80g/L),或血小板<80×10^9/L,或有其他血液系统疾病者; (15)近1年内有慢性腹泻或消化性溃疡病史者; (16)有视网膜病变或角膜病变的患者; (17)有迟发性皮肤卟啉症、银屑病等皮肤病患者; (18)有半乳糖不耐受、Lapp乳糖酶缺陷或葡萄糖-半乳糖吸收不良的罕见的遗传疾病的患者; (19)任何其他可能会导致患者不适合该项临床研究的状况或治疗。 

Exclusion criteria:

(1) Patients with secondary hyperuricemia, such as leukemia, myeloma, renal failure, polycystic kidney disease, some endocrine diseases, some drugs such as diuretics, aspirin, antituberculosis drugs, etc; (2) Combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases; (3) Patients with acute or chronic infectious diseases; (4) Allergic constitution or allergic to the components of this drug, weak constitution; (5) Those who do not meet the inclusion criteria, fail to use drugs and complete the treatment according to the regulations, cannot judge the curative effect or incomplete data, which affects the judgment of efficacy or safety; (6) Patients with malignant tumor; (7) ECG examination showed serious arrhythmia; (8) Mental illness, alcohol abuse, drug or other substance abusers; (9) The mean sitting systolic pressure (SBP) >=140mmHg, DBP >=90mmHg, or SBP >=160mmhg and DBP >=100mmhg during the observation period; (10) Heart failure with reduced ejection fraction (hfref) was clinically diagnosed and had persistent clinical symptoms; (11) Stroke, transient ischemic attack, acute coronary syndrome or deterioration of heart failure requiring hospitalization occurred in the first half of the observation period; (12) Congenital or acquired solitary kidney; (13) Three months before randomization, they participated in other clinical trials; (14) Subjects with WBC < 3.0x10^9/L, anemia (hemoglobin < 80 g/L), platelets < 80x10^9/L, or other blood system diseases; (15) Patients with history of chronic diarrhea or peptic ulcer in recent 1 year; (16) Patients with retinopathy or keratopathy; (17) There were patients with delayed porphyria and psoriasis; (18) Patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption; (19) Any other condition or treatment that may result in the patient not being suitable for the clinical study. 

研究实施时间:

Study execute time:

From2020-10-01To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2020-10-01To 2021-09-30 

干预措施:

Interventions:

组别:

羟氯喹组

样本量:

60

Group:

hydroxychloroquine

Sample size:

干预措施:

羟氯喹+生活方式

干预措施代码:

Intervention:

hydroxychloroquine+life style management

Intervention code:

组别:

安慰剂组

样本量:

60

Group:

placebo

Sample size:

干预措施:

生活方式

干预措施代码:

Intervention:

life style management

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属华东医院 

单位级别:

三甲医院 

Institution
hospital:

Huadong hospital affiliated to Fudan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

尿尿酸排泄

指标类型:

主要指标 

Outcome:

urinary urate excretion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿酸

指标类型:

主要指标 

Outcome:

serum urate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

羟氯喹代谢产物

指标类型:

主要指标 

Outcome:

hydroxychloroquine metabolite

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿外泌体蛋白质组学

指标类型:

主要指标 

Outcome:

Urinary exosome proteomics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

完全随机化分组,将120例原发性高尿酸血症患者按照就诊先后顺序编为1-120号,从随机数字表中的第10行第34列开始,依次读取三位数作为一个随机数录于编号下,然后将全部112个随机数从小到大编序号(数据相同的按先后顺序编序号),规定所编序号1-60号为治疗组,61-120号为对照组。

Randomization Procedure (please state who generates the random number sequence and by what method):

Totally randomized grouping, 120 patients with primary hyperuricemia were numbered 1-120 according to the order of treatment. Starting from the 10th row and the 34th column of the random number table, three digits were read as a random number and recorded under the number.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

ResMan临床试验公共管理平台

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

ResMan Clinical Trial Management Public Platform

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表+ResMan临床试验公共管理平台

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case Record Form+ ResMan Clinical Trial Management Public Platform

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-12
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