Status:
RECRUITING
Testosterone Treatment in Men with Chronic Kidney Disease
Lead Sponsor:
St. Louis University
Collaborating Sponsors:
Clarus Therapeutics, Inc.
Conditions:
Hypogonadism, Male
Kidney Disease, Chronic
Eligibility:
MALE
18-85 years
Phase:
PHASE2
Brief Summary
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 lev...
Detailed Description
* Purpose. The purpose of this research is to find out if JATENZO will help increase testosterone levels in men with hypogonadism and chronic kidney disease, determine if there is any improvement in t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05249634
Start Date
March 15 2022
End Date
December 1 2028
Last Update
March 30 2025
Active Locations (1)
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1
Saint Louis Univeristy
St Louis, Missouri, United States, 63104