Study of JATENZO Oral Therapy to Improve Testosterone and Blood Health in Men with Low Testosterone and Chronic Kidney Disease

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.

Testosterone Treatment in Men With Chronic Kidney Disease