Actively Recruiting
Effect of JATENZO Therapy on Testosterone and Hemoglobin Levels in Men with Low Testosterone and Chronic Kidney Disease
Led by St. Louis University · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
St. Louis University
Lead Sponsor
C
Clarus Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying men with low testosterone and chronic kidney disease to evaluate the effects of an oral testosterone medication called JATENZO. The study aims to see if JATENZO can increase testosterone levels and improve hemoglobin (red blood cells), as well as muscle strength, lean mass, and sexual function. This is a Phase 2 clinical trial focused on men with hypogonadism and kidney issues. Participants will take the JATENZO pill daily for six months. Every 2 to 4 weeks, they will visit the study site for assessments. During these visits, blood samples will be collected, physical exams will be done, vital signs such as height, weight, and blood pressure will be measured, and questionnaires will be completed. Body composition will be measured by a scan, muscle strength will be tested, and the dose of JATENZO may be adjusted based on testosterone levels. Throughout the study, participants will be closely monitored with regular visits to track hormone levels, hemoglobin, muscle strength, lean mass, and sexual function. The main outcome measured is testosterone concentration after six months. Safety and health will be checked with blood tests and physical exams to ensure participant well-being during the trial, which may last up to six months of treatment plus follow-up.
CONDITIONS
Brief Title
Testosterone Treatment in Men With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 to 85 years
- Chronic kidney disease with eGFR between 15 and 45 ml/min/1.73m2
- Low total serum testosterone levels below 300 ng/dl on two morning tests
- Symptoms of low testosterone such as low libido, erectile dysfunction, fatigue, irritability, or decreased muscle mass
- Normal iron stores with serum ferritin of at least 100 ng/mL and transferrin saturation of at least 20%
You will not qualify if you...
- Use of testosterone replacement therapy or androgen supplements in the past 6 months
- Hematocrit over 48%
- Treatment with erythropoiesis stimulating agents
- Uncontrolled blood pressure over 180/100 mm Hg
- Heart failure class III or IV
- Recent (within 3 months) heart attack, stroke, or heart surgery
- Breast cancer or history of prostate cancer
- Prostate specific antigen over 4 ng/ml unless prostate cancer is ruled out
- HIV infection or untreated hepatitis C
- Untreated severe obstructive sleep apnea
- Started iron replacement therapy in the last 3 months
- Recent or recurrent deep vein thrombosis or pulmonary embolism
- Use of warfarin
- Planning to have children within the next year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take the JATENZO pill daily to help increase testosterone levels and possibly improve hemoglobin, muscle strength, lean mass, and sexual function.
Visits every 2 to 4 weeks (in-person) for blood samples, physical exams, vital signs, questionnaires, body scans, and muscle strength tests. Dose may be adjusted based on testosterone levels.
Trial Site Locations
Total: 1 location
1
Saint Louis Univeristy
St Louis, Missouri, United States, 63104
Actively Recruiting
Research Team
S
Sandeep Dhindsa, MD
J
Jennifer Newman, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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