TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation (NCT07287800) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation
United States50 participantsStarted 2025-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.