NCT02712944终止1 期
Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in dosage of Erythropoietin stimulating agents (ESA)
研究概览
简要总结
The purpose of this trial is to evaluate the effect of testosterone replacement in men with renal failure (on dialysis) who also have low testosterone. Specifically, the investigators will assess the change in requirement of Erythropoietin Stimulating agents.
详细描述
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men between ages of 18-80 years of age.
- •Renal failure on hemodialysis
- •Free testosterone <5 ng/dl.
- •Willing to be randomized to intramuscular (IM) testosterone or placebo
- •Currently getting intravenous Epoetin alfa
排除标准
- •Use of testosterone treatment currently or in the past 6 months, including use of over the counter androgen containing health supplements.
- •Congestive heart Failure, class III or IV.
- •Baseline hemoglobin of > 12 g/dl.
- •Allergic reactions to testosterone Vehicle (i.e. Peanut oil)
- •prostate specific antigen>4 ng/ml.
- •History of Prostate Cancer.
- •Liver enzymes >twice the upper limit of normal.
- •HIV or hepatitis C.
- •Severe untreated obstructive sleep apnea (defined as apnea-hypopnea index> 30).
- •Subjects on warfarin or other blood thinners.
- •Active infection (such as foot ulcer)
- •History of adverse events with testosterone use in past.
研究组 & 干预措施
Saline
Placebo Comparator
Saline intramuscular every 2 weeks
干预措施: Saline (Drug)
Testosterone
Active Comparator
Testosterone intramuscular every 2 weeks
干预措施: Testosterone (Drug)
结局指标
主要结局
Change in dosage of Erythropoietin stimulating agents (ESA)
时间窗: primary outcome will be measured at months 5 and 6.
Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.
次要结局
未报告次要终点
研究者
研究点 (1)
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