Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
Study NCT ID:
NCT05249634
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2022-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testosterone Treatment in Men with Chronic Kidney Disease
Sponsor:
St. Louis University
Organization:
Study Overview
Official Title:
Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men with Chronic Kidney Disease
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 levels and hemoglobin (red blood cells).
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 testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass and sexual function.
* The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also involves completing questionnaires, measuring body composition by a scan and testing muscle strength. The dose of JATENZO may be adjusted based on the testosterone levels.
* The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also involves completing questionnaires, measuring body composition by a scan and testing muscle strength. The dose of JATENZO may be adjusted based on the testosterone levels.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: