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

December 12, 2025 updated by: Nima Nassiri, University of California, Los Angeles

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 18 months
Complications categorized by the CTCAE classification (grades 1-5)
18 months
Overall Survival
Time Frame: 18 months
measured as a rate
18 months
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
18 months
Healthcare Utilization Metrics
Time Frame: 18 months
Hospital readmission rates
18 months
Length of hospitalization
Time Frame: 18 months
days
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum Creatinine Levels
Time Frame: At 3-, 6-, and 12-months post-transplantation
measured as mg/dL
At 3-, 6-, and 12-months post-transplantation
estimated glomerular filtration rate (eGFR)
Time Frame: At 3-, 6-, and 12-months post-transplantation
ml/min/1.73 m^2
At 3-, 6-, and 12-months post-transplantation
Rate of delayed graft function
Time Frame: 1 week following transplant
Defined as the need for dialysis within the first week post-transplant.
1 week following transplant
Tacrolimus trough level
Time Frame: 1 month after TRT initiation, and at 3-, 6-, and 12-months post-transplant
ng/mL
1 month after TRT initiation, and at 3-, 6-, and 12-months post-transplant
Follicle-Stimulating Hormone (FSH)
Time Frame: Once prior to initiation of TRT surgery
mIU/mL
Once prior to initiation of TRT surgery
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
Every 3 months after starting TRT; at the time of transplantation; 30-, 90-, 180-, 270-, and 360-days post transplantation
Prostate Specific Antigen (PSA)
Time Frame: at baseline prior to TRT therapy, and every 3-6 months during active hormone therapy.
ng/mL
at baseline prior to TRT therapy, and every 3-6 months during active hormone therapy.
Luteinizing Hormone (LH)
Time Frame: Once prior to initiation of TRT surgery
mIU/mL
Once prior to initiation of TRT surgery
Prolactin
Time Frame: Once prior to initiation of TRT surgery
ng/mL
Once prior to initiation of TRT surgery
Hemoglobin
Time Frame: 1 month after TRT initiation, and at 3-, 6-, and 12-month intervals
To assess for polycythemia, measured as g/dL
1 month after TRT initiation, and at 3-, 6-, and 12-month intervals
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
1 month after TRT initiation, and at 3-, 6-, and 12-month intervals
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
at time of consent, 30 days, 180-days, and 360 days after transplantation
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
at time of consent; every 3-6 months starting TRT; 30- and 90-days following transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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