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

University of California, Los Angeles (UCLA)

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Kidney Transplant

Hypogonadism, Male

End Stage Renal Disease (ESRD)

Treatments

Drug: Testosterone Replacement Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07287800

PATS 20252050 (Other Grant/Funding Number)

IRB-24-5575

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.