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Active, Not Recruiting

NCT Number: NCT07287800

TRT as an Adjunctive ERAS Therapy in ESRD Patients Undergoing Kidney Transplantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypogonadism, Male Chronic Disease Disease Attributes End Stage Renal Disease (ESRD) Endocrine System Diseases Eunuchism Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gonadal Disorders Hypogonadism Kidney Diseases Kidney Failure, Chronic Kidney Transplant Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Testosterone Replacement Therapy

Drug

Testosterone Replacement Therapy

Primary outcomes

  1. Adverse Events

    Time frame: 18 months

    Complications categorized by the CTCAE classification (grades 1-5)

  2. Overall Survival

    Time frame: 18 months

    measured as a rate

  3. Death-Censored- Graft Survival

    Time frame: 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

  4. Healthcare Utilization Metrics

    Time frame: 18 months

    Hospital readmission rates

  5. Length of hospitalization

    Time frame: 18 months

    days

Secondary outcomes

  1. Serum Creatinine Levels

    Time frame: At 3-, 6-, and 12-months post-transplantation

    measured as mg/dL

  2. estimated glomerular filtration rate (eGFR)

    Time frame: At 3-, 6-, and 12-months post-transplantation

    ml/min/1.73 m^2

  3. Rate of delayed graft function

    Time frame: 1 week following transplant

    Defined as the need for dialysis within the first week post-transplant.

  4. Tacrolimus trough level

    Time frame: 1 month after TRT initiation, and at 3-, 6-, and 12-months post-transplant

    ng/mL

  5. Follicle-Stimulating Hormone (FSH)

    Time frame: Once prior to initiation of TRT surgery

    mIU/mL

  6. Serum Testosterone Panel

    Time frame: Every 3 months after starting TRT; at the time of transplantation; 30-, 90-, 180-, 270-, and 360-days post transplantation

    Total, Free, and Bioavailable Testosterone Levels, measured as ng/dL

  7. Prostate Specific Antigen (PSA)

    Time frame: at baseline prior to TRT therapy, and every 3-6 months during active hormone therapy.

    ng/mL

  8. Luteinizing Hormone (LH)

    Time frame: Once prior to initiation of TRT surgery

    mIU/mL

  9. Prolactin

    Time frame: Once prior to initiation of TRT surgery

    ng/mL

  10. Hemoglobin

    Time frame: 1 month after TRT initiation, and at 3-, 6-, and 12-month intervals

    To assess for polycythemia, measured as g/dL

  11. Hematocrit

    Time frame: 1 month after TRT initiation, and at 3-, 6-, and 12-month intervals

    To assess for polycythemia, measured as L/L, read as a percentage

  12. Muscle Body Composition Analysis

    Time frame: at time of consent, 30 days, 180-days, and 360 days after transplantation

    SECA Body Analysis is a non-invasive scan measuring BMI, Fat-Mass Index, Fat Mass Percentage, Skeletal Muscle Mass, and Skeletal Muscle Mass Percentage

  13. Qualitative Assessment of Hypogonadal Symptoms

    Time frame: at time of consent; every 3-6 months starting TRT; 30- and 90-days following transplantation

    qADAM is a validated questionnaire of 10 questions to assess hypogonadal symptoms

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

A Prospective Study of Testosterone Supplementation in Hypogonadal Patients Receiving a Renal Transplant

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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