Testosterone Treatment in Men With Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
SponsorSt. Louis University
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Jatenzo Pill
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
St. Louis University
Lead sponsor
Clarus Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov