今天是:2018-04-21 星期六

前瞻性研究改良意大利方案与足量激素治疗IgA肾病的疗效及安全性分析
下载XML文档

注册号:

Registration number:

ChiCTR1800014442 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

前瞻性研究改良意大利方案与足量激素治疗IgA肾病的疗效及安全性分析 

Public title:

Prospective Study of the Efficacy and Safety of Improved Italy‘scheme therapy for IgA Nephropathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

前瞻性研究改良意大利方案与足量激素治疗IgA肾病的疗效及安全性分析 

Scientific title:

Prospective Study of the Efficacy and Safety of Improved Italy‘scheme therapy for IgA Nephropathy 

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:

李艳 

研究负责人:

付荣国 

Applicant:

Li Yan 

Study leader:

Fu RongGuo 

申请注册联系人电话:

Applicant telephone:

+86 18792559496 

研究负责人电话:

Study leader's telephone:

+86 15291185506 

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:

1047795205@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

pipifu@126.com 

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:

陕西省西安市西五路157号 

研究负责人通讯地址:

陕西省西安市西五路157号 

Applicant address:

157 Xiwu Road, Xi'an, Shaanxi, China 

Study leader's address:

157 Xiwu Road, Xi'an, Shaanxi, 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:

西安交通大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Xi'an JiaoTong University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

西安交通大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Xi'an JiaoTong University 

研究实施负责(组长)单位地址:

陕西省西安市西五路157号 

Primary sponsor's address:

157 Xiwu Road, Xi'an, Shaanxi, 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):

陕西省

市(区县):

Country:

China

Province:

Shaanxi

City:

单位(医院):

西安交通大学第二附属医院

具体地址:

陕西省西安市西五路157号

Institution
hospital:

The Second Affiliated Hospital of Xi'an JiaoTong University

Address:

157 Xiwu Road, Xi'an, Shaanxi, China

经费或物资来源:

自费 

Source(s) of funding:

Self-supporting 

研究疾病:

IgA肾病 

Target disease:

IgA nephropathy 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

研究改良意大利方案对治疗IgA肾病的有效性及安全性。 

Objectives of Study:

To study the efficacy and safety of improved Italyscheme for IgA nephropathy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1. 病理诊断为IgA肾病(免疫荧光检查可见肾小球系膜区IgA沉积); 2. 年龄15-75岁; 3. 尿蛋白定量0.5g/24h-3.5g/24h; 4. 血肌酐≤171umol/L(2mg/dL). 

Inclusion criteria

1. The entry criteria were a histological diagnosis of IgA 2. nephropathy with immunofluorescence showing mesangial IgA 3. deposits, age 15–75years, urinary protein excretion of 0.5–3.5 g daily, and plasma creatinine concentrations of 171mol/L (2 mg/dL) or less. 

排除标准:

1. 3年内使用过类固醇或细胞毒药物; 2. 存在过敏性紫癜、系统性红斑狼疮、糖尿病等可能引起继发性肾脏病; 3. 孕妇及肿瘤患者; 4. 有活动性消化道溃疡; 5. 存在病毒性肝炎或其他严重感染; 6. 存在其他自身免疫性疾病或心、肺、肝等重要脏器功能不全。 

Exclusion criteria:

Exclusion criteria were treatment with steroids or cytotoxic drugs during the previous 3 years, pregnancy, or clinical or biological evidence of Henoch-Schinlein purpura, lupus erythematosus, diabetes mellitus, neoplasia, active peptic-ulcer disease, viral hepatitis, or other infections. 

研究实施时间:

Study execute time:

From2018-01-15To 2019-01-15 

干预措施:

Interventions:

组别:

甲强龙冲击治疗组

样本量:

40

Group:

Methylpredinisolne pluse

Sample size:

干预措施:

甲强龙冲击治疗+强的松小剂量口服

干预措施代码:

Intervention:

Methylpredinisolne pluse therapy+low dose oral glucocorticoids

Intervention code:

组别:

足量激素组

样本量:

40

Group:

Sufficient corticosteroids

Sample size:

干预措施:

足量激素

干预措施代码:

Intervention:

Sufficient corticosteroids

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

陕西 

市(区县):

 

Country:

China 

Province:

Shaanxi 

City:

 

单位(医院):

西安交通大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The second affiliated hospital of Xian JiaoTong university  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

24h尿蛋白定量

指标类型:

主要指标 

Outcome:

24 hours urinary protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾小球滤过率

指标类型:

主要指标 

Outcome:

eGFR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血肌酐

指标类型:

主要指标 

Outcome:

cCr

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白蛋白

指标类型:

主要指标 

Outcome:

albumin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

triglycerides

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胆固醇

指标类型:

主要指标 

Outcome:

cholesterol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

Fasting plasma glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿酸

指标类型:

主要指标 

Outcome:

Uric acid

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标 

Outcome:

blood routine test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

主要指标 

Outcome:

routine urine

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:

肾活检

组织:

肾脏

Sample Name:

renal biopsy

Tissue:

renal

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 15 years
最大 Max age 75 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由实验负责人采用区组随机法随机将病人分为甲强龙冲击治疗组和足量激素组,不采用盲法。

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

The experiment leader randomly divided the patients into methylprednisolone treatment group and enough hormone group using block randomization method, instead of using blind method.

盲法:

Blinding:

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):

2019年6月公布,透过ResMan

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

The data will be shared through ResMan

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:

采用Excel保持患者数据

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

Using Excel to maintain patient data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-01-13
返回列表