20 Participants Needed

Testosterone Treatment for Chronic Kidney Disease

SD
JN
Overseen ByJennifer Newman, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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.12345

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.12367

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.12345

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).

Research Team

SD

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.
See 4 more

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.
See 13 more

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
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
1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 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

Find a Clinic Near You

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+

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

References

Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. [2023]
Testosterone Replacement Therapy: A Narrative Review with a Focus on New Oral Formulations. [2023]
JATENZO®: Challenges in the development of oral testosterone. [2022]
Testosterone Deficiency as One of the Major Endocrine Disorders in Chronic Kidney Disease. [2022]
Testosterone Replacement Therapy in Chronic Kidney Disease Patients. [2022]
Testosterone depot injection in male hypogonadism: a critical appraisal. [2021]
Hypogonadal men treated with oral testosterone undecanoate. [2019]
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