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Hypogonadism, MalePhase 1/2NCT07287800

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

A Phase 1/2 study testing Testosterone Replacement Therapy in people with Hypogonadism, Male and End Stage Renal Disease (ESRD), run by University of California, Los Angeles at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Testosterone Replacement Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Jul 2025to Jun 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, Los Angeles

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: 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.

Being tested
Testosterone Replacement Therapy
Keywords
ESRD, testosterone replacement therapy, hypogonadal, kidney transplant
Medical subject headings
Eunuchism, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone Replacement TherapyDrug

    Testosterone Replacement Therapy

Study groups in NCT07287800
Study groupRoleWhat they receive
Testosterone Replacement TherapyExperimentalNot described
Receives: Drug: Testosterone Replacement Therapy
No Testosterone Replacement TherapyNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

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

    Measured: 18 months

  2. Overall Survival

    measured as a rate

    Measured: 18 months

  3. 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

    Measured: 18 months

  4. Healthcare Utilization Metrics

    Hospital readmission rates

    Measured: 18 months

  5. Length of hospitalization

    days

    Measured: 18 months

Secondary outcomes (13)

  1. Serum Creatinine Levels

    measured as mg/dL

    Measured: At 3-, 6-, and 12-months post-transplantation

  2. estimated glomerular filtration rate (eGFR)

    ml/min/1.73 m^2

    Measured: At 3-, 6-, and 12-months post-transplantation

  3. Rate of delayed graft function

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

    Measured: 1 week following transplant

  4. Tacrolimus trough level

    ng/mL

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

  5. Follicle-Stimulating Hormone (FSH)

    mIU/mL

    Measured: Once prior to initiation of TRT surgery

  6. Serum Testosterone Panel

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

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

  7. Prostate Specific Antigen (PSA)

    ng/mL

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

  8. Luteinizing Hormone (LH)

    mIU/mL

    Measured: Once prior to initiation of TRT surgery

  9. Prolactin

    ng/mL

    Measured: Once prior to initiation of TRT surgery

  10. Hemoglobin

    To assess for polycythemia, measured as g/dL

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

  11. Hematocrit

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

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

  12. 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

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

  13. Qualitative Assessment of Hypogonadal Symptoms

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start1 Jul 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287800
Sponsor's protocol ID
IRB-24-5575
Other IDs
PATS 20252050
Status last verified
Dec 2025
First submitted
1 Dec 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Testosterone Replacement Therapy in people with Hypogonadism, Male and End Stage Renal Disease (ESRD), run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07287800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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