A Prospective Study of Testosterone Supplementation in Hypogonadal Patients Receiving a Renal Transplant
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This prospective study aims to evaluate the safety and efficacy of testosterone replacement therapy (TRT) as an adjunct to an enhanced recover after surgery (ERAS) protocol in men with end-stage renal disease (ESRD) undergoing kidney transplantation.
Participants will be highly-listed hypogonadal men, defined as total testosterone level <300 on two occasions with clinical symptoms of hypogonadism, with ESRD who are expected to receive a kidney transplant within 6 months. Participants will be started on TRT, ideally for at least 3 months prior transplantation. The investigators will perform a subset analysis to evaluate if there is a significant difference in our endpoints by comparing these two subgroups (Three months or more receiving TRT vs. Less than three months receiving TRT). There will be no cut-off time for pre-transplant TRT. Following the intervention period, a historical control cohort of age-matched and health-matched patients will be identified, who have followed a standard transplant protocol that does not incorporate TRT. The primary outcome will evaluate safety, including 30- and 90-day adverse events, 3, 6, and 12-month allograft survival, and overall patient survival. Secondary outcomes will focus on (1) qualitative assessments of symptoms using validated questionnaires, (2) quantitative improvements in the hormonal profile before and after initiation of TRT and surgery, and (3) allograft function and incidence of delayed graft function. The results of this study could provide novel insights into the benefits of TRT in improving surgical outcomes in men with ESRD undergoing kidney transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients older than 18 years old with confirmed end-stage renal disease (ESRD).
- •Hypogonadal (testosterone level <300 ng/dL) with clinical symptoms of hypogonadism.
- •Expected to undergo kidney transplantation within a 6-month period.
- •Able and willing to comply with study procedures and follow-up visits.
排除标准
- •Women or non-hypogonadal men.
- •Any contraindications to testosterone therapy, including:
- •History of Breast Cancer
- •Severe untreated OSA
- •Polycythemia (Hct >54%)
- •Uncontrolled chronic heart failure (CHF)
- •A history of a Major Adverse Cardiac Event (MACE) within the past 6 months
- •Interest in fertility within 1 year
- •An unevaluated PSA >4.0 ng/mL or a PSA >3.0 ng/mL in individuals with risk factors for prostate cancer defined as:
- •Men with African ancestry
- •Men with first-degree relative with prostate cancer
- •Known genetic mutations including BRCA1/2
- •A history of Lynch Syndrome
- •Abnormal DRE
- •Participants already receiving testosterone or other androgen therapies.
- •Severe cardiovascular or pulmonary conditions that pose a high surgical risk.
- •Any condition that, in the opinion of the investigator, would make the subject ineligible for the study.
研究组 & 干预措施
Testosterone Replacement Therapy
干预措施: Testosterone Replacement Therapy (Drug)
结局指标
主要结局
Adverse Events
时间窗: 18 months
Complications categorized by the CTCAE classification (grades 1-5)
Overall Survival
时间窗: 18 months
measured as a rate
Death-Censored- Graft Survival
时间窗: 18 months
Graft Survival will be the duration from transplantation until graft failure. Graft failure defined as (1) resumption of dialysis (2) allograft removal or (3) need for retransplantation/relisted on the transplant list
Healthcare Utilization Metrics
时间窗: 18 months
Hospital readmission rates
Length of hospitalization
时间窗: 18 months
days
次要结局
- Serum Creatinine Levels(At 3-, 6-, and 12-months post-transplantation)
- estimated glomerular filtration rate (eGFR)(At 3-, 6-, and 12-months post-transplantation)
- Rate of delayed graft function(1 week following transplant)
- Tacrolimus trough level(1 month after TRT initiation, and at 3-, 6-, and 12-months post-transplant)
- Follicle-Stimulating Hormone (FSH)(Once prior to initiation of TRT surgery)
- Serum Testosterone Panel(Every 3 months after starting TRT; at the time of transplantation; 30-, 90-, 180-, 270-, and 360-days post transplantation)
- Prostate Specific Antigen (PSA)(at baseline prior to TRT therapy, and every 3-6 months during active hormone therapy.)
- Luteinizing Hormone (LH)(Once prior to initiation of TRT surgery)
- Prolactin(Once prior to initiation of TRT surgery)
- Hemoglobin(1 month after TRT initiation, and at 3-, 6-, and 12-month intervals)
- Hematocrit(1 month after TRT initiation, and at 3-, 6-, and 12-month intervals)
- Muscle Body Composition Analysis(at time of consent, 30 days, 180-days, and 360 days after transplantation)
- Qualitative Assessment of Hypogonadal Symptoms(at time of consent; every 3-6 months starting TRT; 30- and 90-days following transplantation)
研究者
Nima Nassiri
Assistant Clinical Professor of Urology
University of California, Los Angeles