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: 6218292
• 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/6218292
• 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-sponsored 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).

我们已经观察到，在先前GCRC申办的慢性肾衰竭患者的研究中，进展与DHEA-S的血清水平呈负相关;即，这种激素水平相对较低的患者（相对于他们的年龄和性别）进展迅速，而水平相对较高的患者进展缓慢。 基于这一发现，我们在慢性肾功能衰竭患者中开展了一项双盲、随机、交叉、剂量调整的DHEA补充试验。 在确定（通过连续测定肾小球滤过率）（GFR）进展发生后，我们将患者随机分为两组，首先接受安慰剂或DHEA，然后是相反的，在两个相等的观察期内，长度从2到6个月不等（取决于先前的进展速度）。 在两个时期的前四周每周测量DHEA-S的血清水平，并报告给非盲个体，其调整DHEA胶囊相对于安慰剂胶囊的剂量，以达到接近12 μ g/ml的血清DHEA-S水平（在接受DHEA的那些中）。