Testosterone Treatment in Men With Chronic Kidney Disease
Recruiting · NCT05249634 · Interventional (participants receive a specific treatment) · Lead sponsor: St. Louis University
View the official record on ClinicalTrials.gov →Interventions studied
Jatenzo Pill
What this trial is 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).
Who can take part
Age range
18 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Saint Louis Univeristy - St Louis, Missouri, United States