Testosterone Treatment for Chronic Kidney Disease

Recruiting at 1 trial location

Overseen By Jennifer Newman, RN

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: St. Louis University

Must not be taking: TRT, ESA, Warfarin, DHEA

Disqualifiers: Heart failure, Prostate cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

20 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 4 5 6}

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

My kidney function is moderately to severely reduced.

I am a man aged between 18 and 85.

My morning testosterone levels were below 300 ng/dl twice.

Exclusion Criteria

I have not had a blood clot in my veins or lungs in the last 3 months.

I have used testosterone replacement therapy or androgen supplements in the last 6 months.

I started iron replacement therapy within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JATENZO daily for 6 months to evaluate effects on testosterone levels, hemoglobin, muscle strength, lean mass, and sexual function

6 months

Every 2-4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Jatenzo

Trial Overview The study is testing Jatenzo Pill's effect on men with low testosterone and kidney disease to see if it improves their hormone levels and red blood cell count.

How Is the Trial Designed?

Group I: treatment Experimental Treatment 1 Intervention

JATENZO daily for 6 months

Jatenzo is already approved in United States for the following indications:

Approved in United States as Jatenzo for:

• Hypogonadism, Male

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

Clarus Therapeutics, Inc.

Industry Sponsor

Trials

14

Recruited

1,100+

Clarus Therapeutics

Collaborator

Trials

3

Recruited

90+

Published Research Related to This Trial

JATENZO® (testosterone undecanoate) is the first oral testosterone therapy approved by the US FDA for treating testosterone deficiency, addressing the long-standing absence of oral options due to safety concerns like hepatotoxicity.

The article discusses the historical challenges in developing a safe and effective oral testosterone formulation, highlighting how JATENZO® overcomes these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

JATENZO®: Challenges in the development of oral testosterone. Patel, M., Muthigi, A., Ramasamy, R.[2022]

Testosterone replacement therapy (TRT) significantly increased total and free testosterone levels in men with chronic kidney disease and hypogonadism after 3 months, improving symptoms of hypogonadism and erectile dysfunction without significant risks.

The study involved 119 men across different groups (38 on hemodialysis, 46 with chronic kidney disease, and 35 controls), and TRT was found to be safe, showing no significant changes in PSA levels or overhydration risks over 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy in Chronic Kidney Disease Patients. Skiba, R., Rymarz, A., Matyjek, A., et al.[2022]

Reduced testosterone levels are a significant endocrine issue in chronic kidney disease (CKD), leading to various health problems such as infertility, muscle loss, and increased mortality rates.

Testosterone supplementation in CKD patients can improve multiple health aspects, including sexual function, muscle mass, insulin sensitivity, and overall well-being, using methods like injections, pellets, or gels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone Deficiency as One of the Major Endocrine Disorders in Chronic Kidney Disease. Romejko, K., Rymarz, A., Sadownik, H., et al.[2022]

In a 24-month study involving 69 hypogonadal men, oral testosterone undecanoate (TU) significantly increased total testosterone levels into the normal range and improved sexual function across multiple domains, indicating its efficacy as a testosterone replacement therapy.

The treatment was found to be safe, with no significant adverse effects on liver function or prostate health, although there were minor increases in blood pressure and hematocrit levels, which remained within acceptable limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. Honig, S., Gittelman, M., Kaminetsky, J., et al.[2023]

Testosterone undecanoate offers a more stable and effective treatment for androgen deficiency compared to traditional injectable testosterone, with injections spaced 12 weeks apart after an initial loading phase, maintaining plasma testosterone levels within the normal range.

This new formulation has an excellent safety profile, showing no adverse effects on blood parameters, lipid profiles, or prostate health, while effectively reversing symptoms of hypogonadism in bone, muscle, and sexual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone depot injection in male hypogonadism: a critical appraisal. Yassin, AA., Haffejee, M.[2021]

In a study involving three hypogonadal male subjects, oral testosterone undecanoate (120 mg daily for 3 weeks) effectively raised plasma testosterone levels to normal ranges, demonstrating its efficacy as a replacement therapy.

The treatment also led to increased levels of plasma androstenedione and a reduction in sex hormone binding globulin, with patients reporting satisfactory clinical responses, indicating a positive impact on their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypogonadal men treated with oral testosterone undecanoate. Sarris, S., Swyer, GI., Lawrence, DM.[2019]

Male hypogonadism affects a significant portion of the male population (10-30%) and is often not adequately recognized or treated, highlighting the need for effective treatment options.

JATENZO and TLANDO are the first oral testosterone formulations approved by the FDA, utilizing a unique delivery system that allows for safe absorption without causing liver dysfunction, addressing limitations of traditional testosterone replacement therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. Bhat, SZ., Dobs, AS.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05249634

Testosterone Treatment in Men with Chronic Kidney Disease 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, ...

2. biospace.com biospace.com/clarus-announces-initiation-of-phase-4-clinical-trial-of-jatenzo-testosterone-undecanoate-for-the-treatment-of-hypogonadal-men-with-chronic-kidney-disease

Clarus Announces Initiation of Phase 4 Clinical Trial ... JATENZO is the first and only FDA-approved oral softgel for testosterone (T) replacement therapy in adult males who have deficient T due to certain medical ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2049080121006981

The impact of long-term Testosterone Therapy (TTh) in ... The results suggest that long-term TTh could improve renal function in hypogonadal men comparing to slight deterioration observed in patients without ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609522017805

Two-Year Analysis of a New Oral Testosterone ... Long-term data evaluating the efficacy and safety of oral testosterone undecanoate ... disease (eg, type 2 diabetes, chronic kidney disease). To ameliorate the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11439809/

Patient Satisfaction with Oral Testosterone Undecanoate in ... The improvements were observed at both the 3-month and 6-month assessments, with most patients (66.7% at 3 months and 76.0% at 6 months) ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/206089s009lbl.pdf

Jatenzo - accessdata.fda.gov Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer (8.5). See 17 for ...