REFINED ALKALI TREATMENT OF NEPHROLITHIASIS

精碱治疗肾结石

• 批准号: 6105074
• 负责人: CHARLES Y.C PAK
• 金额: $ 16.65万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6105074
• 关键词: citrates; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; hypercalciuria; hyperkalemias; kidney disorder chemotherapy; magnesium; nephrolithiasis; pharmacokinetics; phosphates; potassium; thiazide

The overall goals of this project are to determine whether (a) a special orthophosphate preparation (slow-release potassium phosphate or UroPhos-K) would produce physiological-physicochemical correction, inhibit stone formation, and provide safety of usage in absorptive hypercalciuria, and (b) a novel citrate formulation (potassium-magnesium citrate or K-Mag) would inhibit stone formation and provide safety of usage in patients with calcium stones. In Aim 1, we shall examine the effect of UroPhos-K on the crystallization of stone-forming salts while patients are kept on a constant metabolic diet. Aim 2, to commense upon satisfactory completion of Aim 1, will be a long-term randomized trial between UroPhos-K and placebo on stone formation. In Aim 3, we shall continue ongoing randomized trial between K-Mag and placebo on stone formation. Finally, Aim 4 will assess the value of K-Mag in preventing hypokalemia and magnesium depletion in patients taking thiazide for hypercalciuric nephrolithiasis. This project is biomedically important, since it could lead to the development of UroPhos-K as a rational and effective treatment of absorptive hypercalciuria, and of K-Mag as a superior drug over potassium citrate.

该项目的总体目标是确定(A)是否有特别的 正磷酸盐制剂(缓释磷酸钾或UroPhos-K) 会产生生理-物理化学矫正，抑制结石 形成，并在吸收性高钙尿症中提供使用安全性，以及 (B)一种新的柠檬酸盐配方(柠檬酸钾-镁或K-Mag) 会抑制结石的形成并为患者提供安全的使用 钙结石。在目标1中，我们将研究UroPhos-K对 结石形成盐的结晶，而病人被留在 持续的新陈代谢饮食。目标2，在令人满意的完成后表彰 目标1将是UroPhos-K和UroPhos-K之间的长期随机试验 石层上的安慰剂。在目标3中，我们将继续进行随机 K-Mag和安慰剂在结石形成中的试验。最后，目标4将 评价K-MAg预防低血钾、低镁血症的价值 高钙尿性肾结石患者服用噻嗪的耗竭情况。 这个项目具有重要的生物医学意义，因为它可能导致 UroPhos-K作为一种合理有效的治疗手段的研究进展 吸收性高钙尿症，以及K-MAg作为一种优于钾的药物 柠檬酸盐。