Actively Recruiting
Testosterone Treatment in Men With Chronic Kidney Disease
Led by St. Louis University · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
350 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
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).
CONDITIONS
Official Title
Testosterone Treatment in Men With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men between ages of 18-85 years
- eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation
- Subnormal total serum testosterone concentrations (<300 ng/dl) on two separate morning tests
- Symptoms of hypogonadism such as low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, or loss of body hair
- Normal iron stores defined by serum ferritin 6100 ng/mL and transferrin saturation 620%
You will not qualify if you...
- Current or past 6 months use of testosterone replacement therapy or androgen-containing supplements
- Hematocrit greater than 48%
- Treatment with erythropoiesis stimulating agents
- Uncontrolled blood pressure over 180/100 mm Hg
- Heart failure class III or IV
- Heart attack, stroke, or heart surgery within the past 3 months
- Breast cancer
- History of prostate cancer
- Prostate specific antigen (PSA) over 4 ng/ml unless prostate cancer has been ruled out
- HIV or untreated hepatitis C infection
- Untreated severe obstructive sleep apnea
- Started iron replacement therapy in the last 3 months
- Deep venous thrombosis or pulmonary embolism in the last 3 months
- Recurrent deep venous thrombosis or pulmonary embolism
- Use of warfarin
- Planning to have children in the next year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Saint Louis Univeristy
St Louis, Missouri, United States, 63104
Actively Recruiting
Research Team
S
Sandeep Dhindsa, MD
CONTACT
J
Jennifer Newman, RN
CONTACT
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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