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

NCT07287800 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB-24-5575PATS 20252050
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypogonadism, Male; Kidney Transplant; End Stage Renal Disease (ESRD)

Keywords

ESRD; testosterone replacement therapy; hypogonadal; kidney transplant

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (13)

• Serum Creatinine Levels

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

• estimated glomerular filtration rate (eGFR)

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

• Rate of delayed graft function

  1 week following transplant

• Tacrolimus trough level

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

• Follicle-Stimulating Hormone (FSH)

  Once prior to initiation of TRT surgery

Study Arms (2)

Testosterone Replacement Therapy

EXPERIMENTAL

Drug: Testosterone Replacement Therapy

No Testosterone Replacement Therapy

NO INTERVENTION

Interventions

Testosterone Replacement Therapy DRUG

Testosterone Replacement Therapy

Testosterone Replacement Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Eunuchism; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Urology

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)