Clinical Centers for the HALT-Polycystic Kidney Disease Trials (U01)

HALT-多囊肾病试验临床中心 (U01)

• 批准号: 7920520
• 负责人: RONALD D PERRONE
• 金额: $ 10.82万
• 依托单位: TUFTS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-21 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7920520
• 关键词: Adherence; Adverse effects; Albuminuria; Aldosterone; Antihypertensive Agents; Autosomal Dominant Polycystic Kidney; Blood Pressure; Cardiovascular system; Cessation of life; Clinical; Clinical Trials; Combined Modality Therapy; Dialysis procedure; Disease Progression; End stage renal failure; Enrollment; Excretory function; Frequencies; Glomerular Filtration Rate; Goals; Hospitalization; Hypotension; Individual; Kidney; Kidney Diseases; Kidney Failure; Left Ventricular Mass; Magnetic Resonance Imaging; Measures; Medical; Pain; Participant; Patients; Pharmaceutical Preparations; Phase; Polycystic Kidney Diseases; Principal Investigator; Procedures; Protocols documentation; Quality of life; Questionnaires; Randomized; Renal Blood Flow; Renal function; Research Personnel; Site; Symptoms; System; Time; Transplantation; Upper arm; blood pressure regulation; design; follow-up; meetings; safety study; urinary

DESCRIPTION (provided by applicant): The purpose of this limited competition is to continue patient follow-up and complete the two ongoing HALTPolycystic Kidney Disease (PKD) clinical trials. Tufts-NEMC and the subcontracted site at BIDMC are two of seven patient enrolling sites for HALT-PKD. The HALT-PKD Trials are comprised of two studies (A & B) and are both currently in the patient enrollment phase. HALT-PKD Study A is evaluating the impact of reninangiotensin- aldosterone system (RAAS) blockade on progression of disease in 548 hypertensive PKD patients with estimated glomerular filtration rate (GFR) > 60ml/min/1.73 m2. In Study A, the effect of study medication on structural progression at two different levels of blood pressure control is assessed using a 2x2 factorial design. Accordingly, 548 hypertensive ADPKD participants are randomized to one of four study arms: 1) combination ACE-I/ARB with standard blood pressure (BP) control (systolic 120-130 and diastolic 70-80 mm Hg); 2) ACE-I monotherapy with standard BP control; 3) combination ACEI/ ARB treated to a low BP target (systolic 95-110 and diastolic 60-75 mm Hg); and 4) ACE-I treated to the low BP goal. Other antihypertensive agents are added as needed to meet the BP goals. The primary endpoint of the study is the percent change in total kidney volume, as measured by magnetic resonance imaging (MRI) over time. HALT-PKD Study B is evaluating the impact of RAAS blockade on progression of disease in 472 hypertensive PKD patients with estimated GFR 30-60 ml/min/1.73 m2. The primary endpoint of Study B is a composite endpoint of time to the 50% reduction of baseline estimated GFR, ESRD (initiation of dialysis or preemptive transplant), or death. All 472 hypertensive ADPKD participants are treated to a standard level of blood pressure control (systolic 110-130 mm Hg and diastolic 80 mm Hg), with addition of other antihypertensive agents as needed. This application will describe in detail the two participating clinical centers including the investigators and study teams; adherence to the study protocol; quality and safety of study procedures; and efforts being made to achieve the targeted recruitment goal of 137 study A and 118 study B subjects.

描述（由申请人提供）：本次有限竞赛的目的是继续患者随访并完成两项正在进行的 HALT 多囊肾病 (PKD) 临床试验。 Tufts-NEMC 和 BIDMC 分包站点是 HALT-PKD 七个患者招募站点中的两个。 HALT-PKD 试验由两项研究（A 和 B）组成，目前均处于患者入组阶段。 HALT-PKD 研究 A 正在评估肾素血管紧张素-醛固酮系统 (RAAS) 阻断对 548 名估计肾小球滤过率 (GFR) > 60ml/min/1.73 m2 的高血压 PKD 患者疾病进展的影响。在研究 A 中，使用 2x2 析因设计评估研究药物对两个不同血压控制水平的结构进展的影响。因此，548 名高血压 ADPKD 参与者被随机分配到四个研究组之一：1) 联合 ACE-I/ARB 与标准血压 (BP) 控制（收缩压 120-130 毫米汞柱，舒张压 70-80 毫米汞柱）； 2) ACE-I单一疗法，标准血压控制； 3) 联合ACEI/ARB治疗至低血压目标（收缩压95-110毫米汞柱，舒张压60-75毫米汞柱）； 4) ACE-I 治疗达到低血压目标。根据需要添加其他抗高血压药物以达到血压目标。该研究的主要终点是通过磁共振成像 (MRI) 测量的肾脏总体积随时间变化的百分比。 HALT-PKD 研究 B 正在评估 RAAS 阻断对 472 名估计 GFR 30-60 ml/min/1.73 m2 的高血压 PKD 患者疾病进展的影响。研究 B 的主要终点是基线估计 GFR 降低 50% 的时间、ESRD（开始透析或先发性移植）或死亡的复合终点。所有 472 名高血压 ADPKD 参与者均接受标准血压控制水平（收缩压 110-130 mm Hg，舒张压 80 mm Hg），并根据需要添加其他抗高血压药物。该申请将详细描述两个参与的临床中心，包括研究者和研究团队；遵守研究方案；研究程序的质量和安全性；正在努力实现 137 名研究 A 和 118 名研究 B 受试者的定向招募目标。