NCT05249634 · St. Louis University
Testosterone Treatment in Men With Chronic Kidney Disease
What this study 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 taken by mouth testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).
View original scientific description
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).
Interventions
DRUG
Jatenzo Pill
oral tablet daily
Primary outcome measures
Testosterone concentrations
Time frame: 6 months
Testosterone concentrations in serum measured multiple times during the study
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- St Louis, Missouri
Collaborators
Clarus Therapeutics, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations