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

Phase 2Active Not RecruitingNCT07287800

University of California, Los Angeles50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Adverse Events

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

Time frame: 18 months

Overall Survival

measured as a rate

Time frame: 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

Time frame: 18 months

Healthcare Utilization Metrics

Hospital readmission rates

Time frame: 18 months

Length of hospitalization

days

Time frame: 18 months

Secondary Outcomes

Serum Creatinine Levels

measured as mg/dL

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

estimated glomerular filtration rate (eGFR)

ml/min/1.73 m\^2

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

Rate of delayed graft function

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

Time frame: 1 week following transplant

Tacrolimus trough level

ng/mL

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

Follicle-Stimulating Hormone (FSH)

mIU/mL

Time frame: Once prior to initiation of TRT surgery

Serum Testosterone Panel

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

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

Prostate Specific Antigen (PSA)

ng/mL

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

Luteinizing Hormone (LH)

mIU/mL

Time frame: Once prior to initiation of TRT surgery

Prolactin

ng/mL

Time frame: Once prior to initiation of TRT surgery

Hemoglobin

To assess for polycythemia, measured as g/dL

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

Hematocrit

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

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

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

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

Qualitative Assessment of Hypogonadal Symptoms

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes