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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: End Stage Renal Disease (ESRD); Hypogonadism, Male; Kidney Transplant
• Intervention / Treatment: Drug: Testosterone Replacement Therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Testosterone Replacement Therapy	Drug: Testosterone Replacement Therapy; Testosterone Replacement Therapy
No Intervention: No Testosterone Replacement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Complications categorized by the CTCAE classification (grades 1-5)	18 months
Overall Survival	measured as a rate	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	18 months
Healthcare Utilization Metrics	Hospital readmission rates	18 months
Length of hospitalization	days	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Creatinine Levels	measured as mg/dL	At 3-, 6-, and 12-months post-transplantation
estimated glomerular filtration rate (eGFR)	ml/min/1.73 m^2	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.	1 week following transplant
Tacrolimus trough level	ng/mL	1 month after TRT initiation, and at 3-, 6-, and 12-months post-transplant
Follicle-Stimulating Hormone (FSH)	mIU/mL	Once prior to initiation of TRT surgery
Serum Testosterone Panel	Total, Free, and Bioavailable Testosterone Levels, measured as ng/dL	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	at baseline prior to TRT therapy, and every 3-6 months during active hormone therapy.
Luteinizing Hormone (LH)	mIU/mL	Once prior to initiation of TRT surgery
Prolactin	ng/mL	Once prior to initiation of TRT surgery
Hemoglobin	To assess for polycythemia, measured as g/dL	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	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	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	at time of consent; every 3-6 months starting TRT; 30- and 90-days following transplantation

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ESRD; kidney transplant; hypogonadal; testosterone replacement therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Gonadal Disorders; Renal Insufficiency; Renal Insufficiency, Chronic; Hypogonadism; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Eunuchism
• Other Study ID Numbers: IRB-24-5575; PATS 20252050 (Other Grant/Funding Number: American Urologic Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No