A Phase 1/2 interventional study of Testosterone Replacement Therapy in Hypogonadism, Male, End Stage Renal Disease (ESRD) and Kidney Transplant, sponsored by University of California, Los Angeles. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University of California, Los Angeles · Phase 1/2, Interventional, and Treatment
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.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 55 interventional studies indexed under Eunuchism.
Browse Eunuchism studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any to testosterone therapy, including:
An unevaluated PSA >4.0 ng/mL or a PSA >3.0 ng/mL in individuals with risk factors for prostate cancer defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Testosterone Replacement Therapy
Testosterone Replacement Therapy
Adverse Events
Complications categorized by the CTCAE classification (grades 1-5)
Time frame: 18 months
Overall Survival
measured as a rate
Time frame: 18 months
Death-Censored- Graft Survival
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
Time frame: 18 months
Healthcare Utilization Metrics
Hospital readmission rates
Time frame: 18 months
Length of hospitalization
days
Time frame: 18 months
Serum Creatinine Levels
measured as mg/dL
Time frame: At 3-, 6-, and 12-months post-transplantation
estimated glomerular filtration rate (eGFR)
ml/min/1.73 m\^2
Time frame: At 3-, 6-, and 12-months post-transplantation
Rate of delayed graft function
Defined as the need for dialysis within the first week post-transplant.
Time frame: 1 week following transplant
Tacrolimus trough level
ng/mL
Time frame: 1 month after TRT initiation, and at 3-, 6-, and 12-months post-transplant
Follicle-Stimulating Hormone (FSH)
mIU/mL
Time frame: Once prior to initiation of TRT surgery
Serum Testosterone Panel
Total, Free, and Bioavailable Testosterone Levels, measured as ng/dL
Time frame: Every 3 months after starting TRT; at the time of transplantation; 30-, 90-, 180-, 270-, and 360-days post transplantation
Prostate Specific Antigen (PSA)
ng/mL
Time frame: at baseline prior to TRT therapy, and every 3-6 months during active hormone therapy.
Luteinizing Hormone (LH)
mIU/mL
Time frame: Once prior to initiation of TRT surgery
Prolactin
ng/mL
Time frame: Once prior to initiation of TRT surgery
Hemoglobin
To assess for polycythemia, measured as g/dL
Time frame: 1 month after TRT initiation, and at 3-, 6-, and 12-month intervals
Hematocrit
To assess for polycythemia, measured as L/L, read as a percentage
Time frame: 1 month after TRT initiation, and at 3-, 6-, and 12-month intervals
Muscle Body Composition Analysis
SECA Body Analysis is a non-invasive scan measuring BMI, Fat-Mass Index, Fat Mass Percentage, Skeletal Muscle Mass, and Skeletal Muscle Mass Percentage
Time frame: at time of consent, 30 days, 180-days, and 360 days after transplantation
Qualitative Assessment of Hypogonadal Symptoms
qADAM is a validated questionnaire of 10 questions to assess hypogonadal symptoms
Time frame: at time of consent; every 3-6 months starting TRT; 30- and 90-days following transplantation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Jun 2026, 11 months after the start.
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