Testosterone Treatment in Men with Chronic Kidney Disease

Launched by ST. LOUIS UNIVERSITY · Feb 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of an oral testosterone treatment called JATENZO in men who have low testosterone levels and chronic kidney disease. The goal is to see how this treatment can improve testosterone levels and increase hemoglobin, which is important for making red blood cells. The study is currently looking for participants who are males between the ages of 18 and 85, have specific kidney function measurements, and show symptoms of low testosterone, such as fatigue or low libido.

If you or someone you know is interested in participating, it's important to be aware of the eligibility criteria. Participants should not have used testosterone treatments recently, should have normal iron levels, and must not have certain health conditions like uncontrolled high blood pressure or recent heart problems. Those who join the trial can expect to receive the testosterone treatment and will be monitored for its effects. This study could provide valuable information about treating low testosterone in men with chronic kidney disease.

Gender

MALE

Eligibility criteria

• 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