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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 study 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 assessment, 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, 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
Interested participants should contact the Saint Louis University School of Medicine at: [email protected] or 314-977-9320.
For more information about the trial, visit ClinicalTrials.gov. The study’s Clinical Trials Identifier is NCT05249634.
The study is sponsored and funded by Clarus Therapeutics and Saint Louis University.
Saint Louis University School of Medicine
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious diseases.
About Clarus Therapeutics Holdings, Inc.
Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus’ first commercial product is JATENZO® (testosterone undecanoate). For more information, visit www.clarustherapeutics.com and www.jatenzo.com. Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).
