RecruitingPhase 2NCT05249634

Testosterone Treatment in Men with Chronic Kidney Disease

Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men with Chronic Kidney Disease

Sponsor

St. Louis University

Enrollment

20 participants

Start Date

Mar 15, 2022

Study Type

INTERVENTIONAL

Conditions

Hypogonadism, Male Kidney Disease, Chronic

Summary

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).

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria16

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