NCT05249634 Testosterone Treatment in Men With Chronic Kidney Disease
| NCT ID | NCT05249634 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Louis University |
| Condition | Hypogonadism, Male |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-03-15 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2022-03-15 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Sandeep Dhindsa, MD
PRINCIPAL INVESTIGATOR
St. Louis University
Frequently Asked Questions
Who can join the NCT05249634 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Hypogonadism, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05249634 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05249634 currently recruiting?
Yes, NCT05249634 is actively recruiting participants. Contact the research team at sandeep.dhindsa@health.slu.edu for enrollment information.
Where is the NCT05249634 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05249634 clinical trial?
NCT05249634 is sponsored by St. Louis University. The principal investigator is Sandeep Dhindsa, MD at St. Louis University. The trial plans to enroll 20 participants.