EUCTR2016-000722-19-DE进行中（未招募）1 期
A Multicenter, Single-Arm Study of the Effects of Atrasentan on Spermatogenesis and Testicular Function
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Male subject 30 to 75 years of age, inclusive at the time of Screening.
- •Subject has type 1 or 2 diabetes and is receiving treatment with at least one anti-hyperglycemic medication and ACEi or ARB (RAS inhibitor).
- •Subject has an eGFR = 35 mL/min/1.73 m2 with the CKD-EPI formula and UACR = 30 to < 5,000 mg/g creatinine (= 3.4 mg/mmol and < 565 mg/mmol).
- •Subject is able to provide a semen specimen at the required intervals.
- •Subject has a baseline sperm concentration = 30 million per mL at Screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Subject has had treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids, glucocorticoids, ketoconazole, cyclosporine, or cancer chemotherapy within the 6 months prior to the initial screening visit or planned during the study.
- •Subject is currently receiving or has received hormone replacement therapy within the last 6 months prior to the Screening Period.
- •Subject has a history of severe peripheral edema or facial edema unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial screening visit.
- •Subject has a history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring either oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema).
- •Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.Subject has a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
研究者
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