Testosterone Treatment in Men With Chronic Kidney Disease

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Collaborator: Clarus Therapeutics
• Treatments: Testosterone

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