NCT07287800Active, not recruitingPhase 1/2
TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation
A Prospective Study of Testosterone Supplementation in Hypogonadal Patients Receiving a Renal Transplant
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 1 Jul 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Chronic kidney disease
- NCT number
- NCT07287800
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From 1 Jul 2025 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants already receiving testosterone or other androgen therapies.
Other illness
- 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
- 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.
Other
- Women or non-hypogonadal men.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.