Testosterone Treatment for Low Testosterone in Kidney Disease
Testosterone Treatment in Men With Chronic Kidney Disease
Recruiting
Phase 2Interventional Study
Hypogonadism, MaleKidney Disease, Chronic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
St. Louis University · Other
Who this trial is looking for
This trial is looking for men with low testosterone and chronic kidney disease. Participants will take an oral testosterone medication and have their testosterone levels and red blood cells tested.
Are You a Good Fit for This Trial?
You may be able to join if
I am a man aged 18 to 85 years old.
I have chronic kidney disease with eGFR between 15-45.
I have low testosterone levels on two separate morning tests.
I have symptoms of low testosterone such as low libido or fatigue.
I have normal iron levels in my blood.
You may not be able to join if
I have used testosterone treatment or supplements in the last 6 months.
My hematocrit level is over 48%.
I have uncontrolled high blood pressure.
I have heart failure class III or IV.
I have had a heart attack or stroke in the last 3 months.
I have breast cancer or a history of prostate cancer.
I have untreated HIV or hepatitis C.
I am planning to have children in the next year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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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 guideline…
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
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