Data Coordinating Center for the Halt-Polycystic Kidney Disease Trials

停止多囊肾病试验数据协调中心

• 批准号: 8658816
• 负责人: Kaleab Z Abebe
• 金额: $ 105万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 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: https://reporter.nih.gov/project-details/8658816
• 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

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）：停止的囊肿肾脏疾病（PKD）试验包括2个在7个由中央成像设施，药物分配中心和2个中央实验室支持的7个临床部位进行的全面招募的随机对照试验（A＆B）。 。 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患者的疾病结构进展的肾上腺素 - 血管紧张素 - 醛固酮系统（RAAS）阻断和2级水平的血压控制水平速率（GFR）> 60 mL/min/1.73m2。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，DSMB批准了这两项研究的扩展到2014年7月，以允许研究A（60个月）和5 - 8年的研究。 1）与研究调查人员合作作为Halt-PKD DCC，管理协议和监管合规性，促进数据，图像和生物特异性的转移，并支持HALT-PKD活动，以进行质量控制，终点裁决和血压管理; 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。