Testosterone Treatment in Men with Chronic Kidney Disease

Saint Louis University (SLU)

Status and phase

Enrolling

Phase 2

Conditions

Hypogonadism, Male

Kidney Disease, Chronic

Treatments

Drug: Jatenzo Pill

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05249634

32358

Details and patient eligibility

About

This study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).

Full description

Purpose. The purpose of this research is to find out if JATENZO will help increase testosterone levels in men with hypogonadism and chronic kidney disease, determine if there is any improvement in testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass and sexual function.
The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also involves completing questionnaires, measuring body composition by a scan and testing muscle strength. The dose of JATENZO may be adjusted based on the testosterone levels.

Enrollment

20 estimated patients

Sex

Male

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men between ages of 18-85 years of age
eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation
Subnormal total serum T concentrations (<300 ng/dl) on two separate occasions in morning
Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15)
Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%.

Exclusion criteria

Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)
Hematocrit >48% (as per Endocrine Society guidelines)(15)
Treatment with erythropoiesis stimulating agents (ESA)
Uncontrolled blood pressure (>180/100 mm Hg)
Heart Failure, class III or IV
Myocardial infarction, stroke, or heart surgery in the past 3 months
Breast cancer
History of prostate cancer
Prostate specific antigen (PSA) >4 ng/ml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)
HIV or untreated hepatitis C
Untreated, severe obstructive sleep apnea
Initiated iron replacement in the last 3 months
deep venous thrombosis or pulmonary embolism in the last 3 months
recurrent (more than once) deep venous thrombosis or pulmonary embolism
use of warfarin
Planning to have children in the next one year