Testosterone treatment for men with chronic kidney disease

Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease

This study tests if an oral testosterone treatment called JATENZO can help men with low testosterone and chronic kidney disease feel stronger and improve their overall health over six months.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: St. Louis University (other)
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT05249634 on ClinicalTrials.gov

What this trial studies

This research evaluates the effects of an oral testosterone preparation, JATENZO, in men suffering from low testosterone levels and chronic kidney disease. The study aims to determine if JATENZO can improve testosterone levels, hemoglobin, muscle strength, lean mass, and sexual function over a period of six months. Participants will attend in-person visits every 2-4 weeks for blood samples, physical exams, and questionnaires, with adjustments to the testosterone dose based on individual levels.

Who should consider this trial

Good fit: Ideal candidates are men aged 18-85 with chronic kidney disease and low testosterone levels who exhibit symptoms of hypogonadism.

Not a fit: Patients currently using testosterone replacement therapy or those with uncontrolled blood pressure or severe heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for men with hypogonadism and chronic kidney disease by enhancing testosterone levels and associated symptoms.

How similar studies have performed: Other studies have explored testosterone treatment in similar populations, showing promising results, but this specific approach with JATENZO is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Men between ages of 18-85 years of age
* eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation
* Subnormal total serum T concentrations (\<300 ng/dl) on two separate occasions in morning
* Symptoms of hypogonadism (as per Endocrine Society guidelines): low libido, erectile dysfunction, fatigue, irritability, depressed mood, poor concentration, increased body fat, decreased muscle bulk, reduced physical performance, sleep disturbance, loss of body hair (15)
* Normal iron stores as defined by serum ferritin ≥100 ng/mL and transferrin saturation (TSAT) ≥20%.

Exclusion Criteria:

* Use of TRT currently or in the past 6 months, including use of over-the-counter androgen containing health supplements (e.g., DHEA)
* Hematocrit \>48% (as per Endocrine Society guidelines)(15)
* Treatment with erythropoiesis stimulating agents (ESA)
* Uncontrolled blood pressure (\>180/100 mm Hg)
* Heart Failure, class III or IV
* Myocardial infarction, stroke, or heart surgery in the past 3 months
* Breast cancer
* History of prostate cancer
* Prostate specific antigen (PSA) \>4 ng/ml, unless prostate cancer has been ruled out by a urologist (documented in physician notes)
* HIV or untreated hepatitis C
* Untreated, severe obstructive sleep apnea
* Initiated iron replacement in the last 3 months
* deep venous thrombosis or pulmonary embolism in the last 3 months
* recurrent (more than once) deep venous thrombosis or pulmonary embolism
* use of warfarin
* Planning to have children in the next one year

Where this trial is running

St Louis, Missouri

• Saint Louis Univeristy — St Louis, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Sandeep Dhindsa, MD — St. Louis University
• Study coordinator: Sandeep Dhindsa, MD

Conditions: Hypogonadism, Male, Kidney Disease, Chronic, testosterone, CKD