NCT05249634RecruitingPhase 2
Testosterone Treatment in Men With Chronic Kidney Disease
Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Feb 2022
- Start date
- 15 Mar 2022
- Primary completion date
- Jun 2028
- Lead sponsor
- St. Louis University
- Diseases
- Chronic kidney disease
- NCT number
- NCT05249634
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 15 Mar 2022 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with erythropoiesis stimulating agents (ESA)
Other illness
- 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
- deep venous thrombosis or pulmonary embolism in the last 3 months
- recurrent (more than once) deep venous thrombosis or pulmonary embolism
Other
- 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)
- Uncontrolled blood pressure (\>180/100 mm Hg)
- Untreated, severe obstructive sleep apnea
- Initiated iron replacement in the last 3 months
- use of warfarin
- Planning to have children in the next one year
Who the study is looking for
- 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%.
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Louis Univeristy Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.