Investigational drug trial (JATENZO®) for hypogonadal men with CKD

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ST. LOUIS - Researchers at Saint Louis University School of Medicine are enrolling volunteers in an investigational drug trial for hypogonadal men with chronic kidney disease.

The Phase 4 clinical trial is designed to evaluate the efficacy and safety of JATENZO, an oral soft gel capsule for the treatment of adult hypogonadal men with chronic kidney disease (CKD).

Chronic kidney disease is a condition where the kidney gradually loses function over time and can result in serious health problems and sometimes even death. More than two million men with CKD also suffer from hypogonadism, a condition when the testes do not produce enough testosterone (T).


Other health problems associated with CKD can include anemia, loss of muscle mass, and a decrease in quality of life.

“We know in men suffering from CKD that T levels decrease as kidney function decreases. These men may also have a decrease in hemoglobin levels (anemia) that need to be treated with often expensive medications, such as epoetin,”
said Sandeep Dhindsa, M.D., a professor of endocrinology at Saint Louis University School of Medicine and primary investigator in this trial. “Because JATENZO increases T levels and has a positive impact on hemoglobin levels, our hypothesis is that JATENZO, with its flexible oral dosing options, could become an important treatment option for hypogonadal adult men with CKD.”

This Phase 4 clinical trial is an investigator-initiated, single-center, single-arm s
tudy to investigate if adult men with Stage 3b or Stage 4 CKD and hypogonadism will show improvement when treated with JATENZO twice daily for 26 weeks.

Researchers will measure hemoglobin, free T, lean mass, muscle strength, fat mass, sexual function, quality of life, and key safety variables from the start of the trial to after six months of treatment with JATENZO.


The SLU research team includes Kevin Martin, M.D., professor of nephrology; Marie Philipneri, Ph.D., professor of nephrology; Ezequiel Bellorin-Font, M.D., instructor in nephrology; Edward Weiss, Ph.D., professor of nutrition and dietetics; and Guoyu Ling, M.D., Ph.D. assistant professor of endocrinology.

To enroll, participants must be men aged 18-85 with symptoms of hypogonadism including low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, and loss of body hair, with normal iron stores. Men with heart or blood pressure issues and those with a history of prostate cancer or deep venous thrombosis are not eligible. Men who are planning to have children in the next year are also not eligible for participation.

Participants will be asked to:

  • Make two screening visits in the morning after fasting to the endocrinology research space in SLU’s Salus Center.
  • Make 9 research visits in person over 26 weeks. At the visits, participants will be given several weeks’ supply of JATENZO for at-home dosing.
  • Have blood drawn several times for safety monitoring and to measure serum T
  • Keep track of how they’re feeling
 
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Testosterone Treatment in Men With Chronic Kidney Disease


Study Description

Brief Summary:


This study is being conducted on 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, and determine if there is any improvement in testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass, and sexual function. The drug will be given 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, and 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 testosterone levels.
 
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