NCT05249634招募中2 期
Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Testosterone concentrations
研究概览
简要总结
This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).
详细描述
- Purpose. The purpose of this research is to find out if JATENZO will help increase testosterone levels in men with hypogonadism and chronic kidney disease, determine if there is any improvement in testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass and sexual function.
- The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also involves completing questionnaires, measuring body composition by a scan and testing muscle strength. The dose of JATENZO may be adjusted based on the testosterone levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men between ages of 18-85 years of age
- •eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation
- •Subnormal total serum T concentrations (<300 ng/dl) on two separate occasions in morning
- •Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15)
- •Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%.
排除标准
- •Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)
- •Hematocrit >48% (as per Endocrine Society guidelines)(15)
- •Treatment with erythropoiesis stimulating agents (ESA)
- •Uncontrolled blood pressure (>180/100 mm Hg)
- •Heart Failure, class III or IV
- •Myocardial infarction, stroke, or heart surgery in the past 3 months
- •Breast cancer
- •History of prostate cancer
- •Prostate specific antigen (PSA) >4 ng/ml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)
- •HIV or untreated hepatitis C
- •Untreated, severe obstructive sleep apnea
- •Initiated iron replacement in the last 3 months
- •deep venous thrombosis or pulmonary embolism in the last 3 months
- •recurrent (more than once) deep venous thrombosis or pulmonary embolism
- •use of warfarin
- •Planning to have children in the next one year
研究组 & 干预措施
treatment
Experimental
JATENZO daily for 6 months
干预措施: Jatenzo Pill (Drug)
结局指标
主要结局
Testosterone concentrations
时间窗: 6 months
Testosterone concentrations in serum measured multiple times during the study
次要结局
- Lean mass(6 months)
- sexual function(6 months)
- Hemoglobin(6 months)
- muscle strength(6 months)
研究者
Sandeep Singh Dhindsa, M.D.
Professor of Medicine
St. Louis University
研究点 (2)
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