Testosterone treatment for men with chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Saint Louis Univeristy
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Sandeep Dhindsa, MD — St. Louis University
• Study coordinator: Sandeep Dhindsa, MD
• Email: sandeep.dhindsa@health.slu.edu
• Phone: 314-977-9320

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exercise Self-Efficacy, Body Composition, and Activity in Men with Low Testosterone

  This study tests how confident men on testosterone therapy are at staying active and whether that confidence links body fat and lean mass with how much they exercise.

  Recruiting at 2 sites Hacettepe University · Bingoel and 1 other locations · NCT07924514

• Male Hypogonadism: How Stigma and Identity relate to Quality of Life

  This study tests whether men with hypogonadism feel more anticipated stigma and have a different illness identity compared with men with other chronic endocrine conditions, and whether those psychosocial factors predict quality of life.

  Recruiting at 2 sites Hacettepe University · Bingoel and 1 other locations · NCT07752511

• AdiaVita regenerative therapy for chronic kidney disease

  This trial tests whether AdiaVita (umbilical cord blood stem cells and exosomes plus glutathione) can improve kidney function in adults with stage 2–4 chronic kidney disease.

  Recruiting Phase 1 Adia Med of Winter Park LLC · Winter Park, Florida · NCT07572890

• Ketoanalogue supplements to protect muscle in advanced chronic kidney disease on a moderately low‑protein diet

  This tests whether adding ketoacid/amino‑acid supplements to a moderately low‑protein diet helps protect muscle and slow kidney decline in adults with stage 4–5 chronic kidney disease who are not yet on dialysis.

  Recruiting Phase 3 University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT07374042

• Testosterone therapy in men with low-risk prostate cancer on active surveillance

  This study tests whether testosterone replacement can be safely used in men with newly diagnosed low-risk prostate cancer who are under active surveillance and have hypogonadism.

  Recruiting at 2 sites Phase 4 University of Miami · Miami, Florida and 1 other locations · NCT07278362

• Rutgers University Genetics of Kidney Disease

  This project will see if genes are linked to kidney disease risk by collecting health surveys and saliva DNA from people 18 and older in the U.S.

  Recruiting Rutgers, The State University of New Jersey · Piscataway, New Jersey · NCT07217535

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.