HYPERCALCIURIC NEPHROLITHIASIS TRIAL BETWEEN UROPHOS-K AND UROCIT-K

UROPHOS-K 和 UROCIT-K 之间的高钙肾结石试验

• 批准号: 6564156
• 负责人: HOWARD J HELLER
• 金额: $ 22.85万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-12-01 至 2002-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6564156
• 关键词: bone density; citrates; clinical research; human subject; human therapy evaluation; hypercalciuria; kidney disorder chemotherapy; longitudinal human study; nephrolithiasis; outcomes research; phosphates; potassium

Description: (Taken Directly from the application) Absorptive hypercalciuria is a stone-forming condition in which hypercalciuria is believed to result from the primary enhancement of intestinal calcium absorption. Absorptive hypercalciuria is probably heterogeneous in origin, and may be broadly categorized into vitamin D-independent and vitamin D-dependent forms. Thus, besides recurrent nephrolithiasis, absorptive hypercalciuria is not known, but we have implicated a potential role of the catabolic skeletal effect of calcitriol excess. Therefore, since current long-term treatment is far from satisfactory, an ideal treatment should be one which produces a sustained correction of excessive intestinal absorption and renal excretion of calcium, and averts bone loss. This need has led to our hypothesis that a special formulation of orthophosphate (slow-release neutral potassium phosphate or UroPhos-K) would correct hypercalciuria, prevent recurrent stone formation and provide safety of usage in hypercalciuric nephrolithiasis due to absorptive hypercalciuria. In a controlled randomized trial, the effect of UroPhos-K will be compared with that of Urocit-K (potassium citrate) in hypercalciuric patients with absorptive hypercalciuria. The hypothesis to be tested is that UroPhos-K would lower urinary calcium unlike Urocit-K, and would be more effective than Urocit-K in inhibiting new stone formation. The safety and positive physicochemical and physiological effects of UroPhos-K in inhibiting new stone formation. The safety and positive physicochemical and physiological effects of UroPhos-K disclosed from ongoing long-term non-randomized trial provided the impetus to initiate this randomized trial.

产品描述：吸收性高钙尿症是一种结石形成疾病，其中高钙尿症被认为是由肠道钙吸收的主要增强引起的。吸收性高钙尿症可能是异质性的起源，并可大致分为维生素D非依赖型和维生素D依赖型。因此，除了复发性肾结石，吸收性高钙尿症是未知的，但我们已经暗示了骨化三醇过量的分解代谢骨骼效应的潜在作用。因此，由于目前的长期治疗远不能令人满意，理想的治疗应该是持续纠正过度的肠吸收和肾排泄钙，并避免骨丢失。这种需求导致我们假设，一种特殊的正磷酸盐制剂（缓释中性磷酸钾或UroPhos-K）可以纠正高钙尿症，预防复发性结石形成，并为因吸收性高钙尿症引起的高钙尿症肾结石提供安全的使用。在一项对照随机试验中，将比较UroPhos-K与Urocit-K（柠檬酸钾）在吸收性高钙尿症患者中的作用。待检验的假设是，UroPhos-K与Urocit-K不同，会降低尿钙，并且在抑制新结石形成方面比Urocit-K更有效。UroPhos-K在抑制新结石形成方面的安全性和积极的理化和生理作用。正在进行的长期非随机试验中披露的UroPhos-K的安全性和积极的理化和生理作用为启动本随机试验提供了动力。