Data Coordinating Center for the Halt-Polycystic Kidney Disease Trials
停止多囊肾病试验数据协调中心
基本信息
- 批准号:8658816
- 负责人:
- 金额:$ 105万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2008
- 资助国家:美国
- 起止时间:2008-09-15 至 2017-07-31
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
DESCRIPTION (provided by applicant): The HALT-Polycystic Kidney Disease (PKD) trials comprise 2 fully enrolled randomized controlled trials (A & B) conducted at 7 clinical sites supported by a central imaging facility, a drug distribution center, and 2 central laboratories. HALT-PKD Study A uses a 2x2 factorial design to evaluate the impact of rennin-angiotensin-aldosterone system (RAAS) blockade and 2 levels of blood pressure control on structural progression of disease in 558 high-normal or hypertensive PKD patients with estimated glomerular filtration rate (GFR) >60 ml/min/1.73m2. The primary outcome is total kidney volume (TKV) measured at 0, 24, and 48 months. HALT- PKD Study B evaluates the impact of RAAS blockade on progression of disease in 486 hypertensive PKD patients with estimated GFR 30-60 ml/min/1.73m2. The primary outcome is a combined endpoint defined by >50 percent reduction in eGFR, ESRD, or death. Participants are followed for 4-7 years. For Study A, there is strong evidence to show the impact of TKV on kidney function (GFR) takes several years to manifest implying the short period of follow-up for Study A (48 months) may be insufficient to see changes on kidney function. For Study B, the observed number of endpoints at 5 years is lower than had been predicted to provide power for 25 percent reduction in outcome. As a result of these new findings and interim analyses, the DSMB approved extension of both studies through July 2014 to allow an additional measure for Study A (60 months) and 5-8 years follow-up for study B. We propose to continue to serve as the HALT-PKD DCC by 1) collaborating with study investigators, managing protocol and regulatory compliance, facilitating the transfer of data, images, and bio-specimens, and supporting HALT- PKD activities for quality control, endpoint adjudication, and blood pressure management; 2) maintaining the Web-based data management system that incorporates data tracking, entry, quality control, and report generation; 3) conducting interim and final statistical analyses to support the study aims including the future primary analyses for Study A and Study B. Public
描述(由申请人提供):停止的囊性肾脏疾病(PKD)试验包括2个全面招募的随机对照试验(A&B),该试验(A&B)在由中央成像设施,药物分配中心和2个中央实验室支持的7个临床部位进行。 HALT-PKD研究A使用2x2阶乘设计来评估558名高正常或高血压PKD患者估计肾小球过滤率(GFR)> 60 mL/MIN MIN/MIN/MIN/MIN/1.73M2的558例高正常或高血压PKD患者疾病结构进展的血压控制对疾病结构进展的影响。主要结果是在0、24和48个月测得的总肾脏体积(TKV)。 Halt-PKD研究B评估了486例GFR 30-60 mL/min/1.73m2的486例高血压PKD患者中RAAS封锁对疾病进展的影响。主要结果是EGFR,ESRD或死亡降低> 50%的合并终点。参与者持续了4 - 7年。对于研究A,有充分的证据表明TKV对肾脏功能(GFR)的影响需要几年才能表明研究A(48个月)的短期随访可能不足以看到肾脏功能的变化。对于研究B,观察到的5年端点数量低于预测的预测,预计降低了25%的结果。由于这些新发现和临时分析的结果,DSMB批准了两项研究到2014年7月的范围,以允许研究A(60个月)和5 - 8年的研究。质量控制,终点裁决和血压管理的活动; 2)维护基于Web的数据管理系统,该系统结合了数据跟踪,输入,质量控制和报告生成; 3)进行临时和最终统计分析以支持该研究的目的,包括未来研究和研究的主要分析。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

暂无数据
数据更新时间:2024-06-01
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