Testosterone Treatment for Chronic Kidney Disease

Overseen by Sandeep Dhindsa, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: St. Louis University

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

Disqualifiers: Heart failure, Prostate cancer, HIV, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study in being conducted in 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).

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.

What data supports the effectiveness of the drug Jatenzo for treating chronic kidney disease?

Testosterone replacement therapy, like Jatenzo, can help improve symptoms in chronic kidney disease patients by increasing muscle mass, improving mood, and enhancing sexual function. Research shows that testosterone therapy can effectively address low testosterone levels, which are common in chronic kidney disease, and improve related symptoms. ^{1 2 3 4 5}

Is oral testosterone undecanoate (Jatenzo) safe for humans?

Oral testosterone undecanoate (Jatenzo) has been shown to be a safe option for testosterone replacement therapy, with no evidence of liver dysfunction and a good safety profile in maintaining normal testosterone levels without adverse effects on lipid profiles or prostate safety. ^{1 2 3 6 7}

How does the drug Jatenzo differ from other treatments for chronic kidney disease?

Jatenzo is unique because it is the first oral testosterone formulation approved by the FDA, using a special delivery system that avoids liver damage, unlike other testosterone treatments that are typically gels, patches, or injections. ^{1 2 3 4 5}

Research Team

Sandeep Dhindsa, MD

Principal Investigator

St. Louis University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Jatenzo (Androgen)

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.

Participant Groups

Group I: treatment Experimental Treatment 1 Intervention

JATENZO daily for 6 months

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

Dr. Laura Simpson

St. Louis University

Chief Medical Officer since 2023

PhD in Molecular and Cellular Biology from Tulane University

Dr. Keith Vendola

St. Louis University

Chief Executive Officer since 2023

PhD in Molecular Biology from Washington University in St. Louis

Clarus Therapeutics, Inc.

Industry Sponsor

Trials

14

Recruited

1,100+

Clarus Therapeutics

Collaborator

Trials

3

Recruited

90+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. [2023]

3. England pubmed.ncbi.nlm.nih.gov

JATENZO®: Challenges in the development of oral testosterone. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Testosterone Deficiency as One of the Major Endocrine Disorders in Chronic Kidney Disease. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Testosterone Replacement Therapy in Chronic Kidney Disease Patients. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Hypogonadal men treated with oral testosterone undecanoate. [2019]