PHASE II TRIAL OF DHEA IN CHRONIC RENAL FAILURE

DHEA 治疗慢性肾功能衰竭的 II 期试验

• 批准号: 6297554
• 负责人: MACKENZIE WALSER
• 金额: $ 0.23万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6297554
• 关键词: chronic renal failure; clinical research; dehydroepiandrosterone; dosage; drug administration rate /duration; drug screening /evaluation; hormone therapy; human subject; human therapy evaluation; kidney disorder chemotherapy; pathologic process

We have observed, in previous GCRC-supported studies of patients with chronic renal failure, that progression in negatively correlated with serum level of DHEA-S; i.e., patients with relatively low levels of this hormone (for their age and gender) progress rapidly while patients with relatively high levels progress slowly. Based on this finding, we have instituted a double-blind, randomized, crossover, dose- adjustment trial of DHEA supplementation in patients with chronic renal failure. After establishing (by sequential determinations of glomerular filtration rate) (GFR) that progression is occurring, we randomize patients to receive either placebo or DHEA first, followed by the opposite, in two equal periods of observation, varying in length from 2 to 6 months (depending on the prior rate of progression). Serum levels of DHEA-S are measured weekly for the first four weeks of both periods, and reported to an unblinded individual, who adjusts the dosage of DHEA capsules vs. placebo capsules so as to achieve a serum DHEA-S level approximating 12 ug/ml (in those receiving DHEA). So far 8 patients have entered this protocol. Two patients, one with non- insulin-dependent diabetes mellitus and one with IgA nephropathy, have shown accelerated progression during DHEA supplementation. One patient with insulin-dependent diabetes mellitus and one with polycystic kidney disease have shown slowed progression during DHEA supplementation. Our future studies will be limited to these latter two disorders. DHEA toxicity has not been noted otherwise.

我们已经观察到，在以前的GCRC支持的患者研究中， 慢性肾功能衰竭的进展与 与DHEA-S的血清水平有关;即，水平相对较低的患者 这种激素（对于他们的年龄和性别）的进展迅速， 水平相对较高的患者进展缓慢。 基于此 发现，我们已经建立了一个双盲，随机，交叉，剂量- 慢性肾病患者补充DHEA的调整试验 失败 在建立（通过连续测定 肾小球滤过率）（GFR），进展正在发生，我们 将患者随机分为安慰剂组和DHEA组， 相反，在两个相等的观察期内， 2至6个月（取决于之前的进展速度）。 血清 DHEA-S的水平在前四周每周测量， 周期，并报告给未设盲的个体，由其调整剂量 的DHEA胶囊与安慰剂胶囊，以实现血清DHEA-S 水平接近12微克/毫升（在那些接受DHEA）。 到目前为止8 患者已进入该方案。 两个病人，一个没有- 胰岛素依赖型糖尿病和伊加肾病， 在DHEA补充期间显示加速进展。 一名患者 患有胰岛素依赖型糖尿病和多囊肾 在DHEA补充期间，疾病进展缓慢。 我们 未来的研究将限于后两种疾病。 DHEA 另外未发现毒性。