PHASE II TRIAL OF DHEA IN CHRONIC RENAL FAILURE

我们在之前的GCRC赞助的慢性肾功能衰竭患者研究中观察到，进展与血清脱氢表雄酮-S水平呈负相关；即这种激素水平相对较低的患者(就他们的年龄和性别而言)进展较快，而水平相对较高的患者进展较慢。基于这一发现，我们对慢性肾功能衰竭患者进行了DHEA补充的双盲、随机、交叉、剂量调整试验。在(通过连续测定肾小球滤过率)(GFR)确定进展正在发生后，我们将患者随机分为两个相等的观察期，首先接受安慰剂或DHEA，然后接受相反的治疗，观察时间从2个月到6个月不等(取决于先前的进展速度)。在这两个周期的前四周，每周测量一次脱氢表雄酮-S的血清浓度，并向一名非盲人报告，该名非盲人调整脱氢表雄酮胶囊与安慰剂胶囊的剂量，以使血清脱氢表雄酮-S的浓度接近12ug/ml(接受脱氢表雄酮的人)。

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).