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：
8518014
负责人：
Charity G Patterson (Moore)
金额：
$ 125万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
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 2015-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8518014
关键词：
Affect Aldosterone American Angiotensins Area Attenuated Autosomal Dominant Polycystic Kidney Blood Pressure Cessation of life Chymosin Clinical Clinical Data Clinical Trials Data Monitoring Committees Combined Modality Therapy Computer Retrieval of Information on Scientific Projects Database Contractor Data Data Analyses Data Coordinating Center Databases Disease Progression Doctor of Philosophy Drug Packaging End stage renal failure Enrollment Event Feedback Future Generations Genetic Glomerular Filtration Rate Health Healthcare Hypertension Hypotension Image Image Analysis Individual Information Systems Inherited Intervention Kidney Kidney Diseases Kidney Failure Laboratories Manuscripts Measures Monitor Morbidity - disease rate National Institute of Diabetes and Digestive and Kidney Diseases Online Systems Outcome Participant Patients Pharmacologic Substance Polycystic Kidney Diseases Protocols documentation Quality Control Randomized Controlled Trials Renal function Renin-Angiotensin-Aldosterone System Reporting Research Research Design Research Personnel Site Site Visit Specimen Structure System Testing Time Universities Work adjudication biobank blood pressure regulation clinical research site cohort cost effective data management design drug distribution efficacy testing follow-up meetings patient safety primary outcome repository satisfaction statistical center

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）：HALT-多囊肾病 (PKD) 试验包括 2 项完全入组的随机对照试验 (A 和 B)，在 7 个临床中心进行，由中央成像设施、药物配送中心和 2 个中心实验室支持。 HALT-PKD 研究 A 使用 2x2 析因设计来评估肾素-血管紧张素-醛固酮系统 (RAAS) 阻断和 2 级血压控制对 558 名估计肾小球滤过的高正常或高血压 PKD 患者的疾病结构进展的影响率 (GFR) >60 毫升/分钟/1.73 平方米。主要结局是在 0、24 和 48 个月时测量的肾总体积 (TKV)。 HALT-PKD 研究 B 评估了 486 名估计 GFR 为 30-60 ml/min/1.73m2 的高血压 PKD 患者中 RAAS 阻断对疾病进展的影响。主要结局是一个综合终点，定义为 eGFR、ESRD 或死亡降低 50% 以上。参与者被跟踪4-7年。对于研究 A，有强有力的证据表明 TKV 对肾功能 (GFR) 的影响需要数年时间才能显现，这意味着研究 A 的短期随访（48 个月）可能不足以看到肾功能的变化。对于研究 B，观察到的 5 年终点数量低于预期，导致结果降低 25%。由于这些新发现和中期分析，DSMB 批准将两项研究延长至 2014 年 7 月，以便对研究 A 采取额外措施（60 个月），并对研究 B 进行 5-8 年随访。我们建议继续作为 HALT-PKD DCC，1) 与研究研究者合作，管理方案和监管合规性，促进数据、图像和生物样本的传输，并支持 HALT-PKD 质量控制、终点活动裁决和血压管理； 2) 维护基于网络的数据管理系统，包括数据跟踪、输入、质量控制和报告生成； 3) 进行中期和最终统计分析以支持研究目标，包括研究 A 和研究 B 的未来初步分析。