Testosterone Treatment for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how an oral testosterone treatment called JATENZO affects testosterone levels and red blood cells in men with both low testosterone and chronic kidney disease. Researchers aim to determine if taking JATENZO daily for six months can improve these conditions. Suitable candidates for this trial have chronic kidney disease, low testosterone levels (less than 300 ng/dl), and symptoms such as low sex drive, tiredness, or mood changes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot participate if you are using testosterone replacement therapy or certain other treatments like erythropoiesis stimulating agents or warfarin.
Is there any evidence suggesting that Jatenzo is likely to be safe for humans?
Research has shown that Jatenzo, a pill for increasing testosterone, is usually well-tolerated by patients. In earlier studies, very few participants experienced side effects. For instance, only one participant left a study due to a pre-existing kidney problem.
The FDA has approved Jatenzo for treating low testosterone in men, indicating a certain level of safety. However, limited information exists about its long-term safety, such as potential risks for heart issues or prostate cancer. Participants should consider this when deciding to join a trial.
Overall, current research suggests Jatenzo is safe for short-term use to increase testosterone levels, but the long-term effects remain under study.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for chronic kidney disease, which often focus on managing symptoms or slowing disease progression through medications like ACE inhibitors and ARBs, Jatenzo offers a novel approach by utilizing testosterone therapy. Researchers are excited about Jatenzo because it is an oral testosterone replacement, which could improve energy levels and muscle mass in patients with chronic kidney disease, who often suffer from low testosterone levels. This treatment's unique delivery as a pill is particularly appealing, as it offers a convenient alternative to testosterone injections or gels, making it easier for patients to adhere to the treatment regimen.
What evidence suggests that Jatenzo might be an effective treatment for chronic kidney disease?
Research has shown that Jatenzo, a pill for boosting testosterone, can help men with low testosterone and chronic kidney disease. Studies found that men taking Jatenzo had higher testosterone levels, which can increase energy and muscle strength. Long-term use of testosterone therapy has also been linked to improved kidney function in these men. Most patients report feeling healthier and more satisfied after using Jatenzo for a few months. These findings suggest that Jatenzo could be a promising treatment for men with low testosterone and chronic kidney disease.13456
Who Is on the Research Team?
Sandeep Dhindsa, MD
Principal Investigator
St. Louis University
Are You a Good Fit for This Trial?
Men aged 18-85 with low testosterone and chronic kidney disease (eGFR 15-45 ml/min/1.73m2) can join this trial. They should have symptoms like low sex drive, mood changes, or loss of muscle. Men on warfarin, those who've had recent heart issues or blood clots, or with untreated severe conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive JATENZO daily for 6 months to evaluate effects on testosterone levels, hemoglobin, muscle strength, lean mass, and sexual function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Jatenzo
Jatenzo is already approved in United States for the following indications:
- Hypogonadism, Male
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Louis University
Lead Sponsor
Clarus Therapeutics, Inc.
Industry Sponsor
Clarus Therapeutics
Collaborator