New pill could boost testosterone in men with kidney disease
NCT ID NCT05249634
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests an oral testosterone pill called JATENZO in 20 men who have both low testosterone and chronic kidney disease. The goal is to see if the pill can raise testosterone levels and improve red blood cell counts, muscle strength, lean body mass, and sexual function. Participants take the pill daily for several weeks, and researchers monitor their blood and overall health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JATENZO (oral testosterone)
- What this could lead to
- If successful, this could offer a convenient oral treatment option for low testosterone in men with chronic kidney disease, potentially improving energy, muscle strength, and sexual function.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply to everyone. Oral testosterone may have side effects like liver strain or blood pressure changes, and it is not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Saint Louis Univeristy
RECRUITINGSt Louis, Missouri, 63104, United States
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