Recruiting
Phase 2

Testosterone

Sponsor:

St. Louis University

Code:

NCT05249634

Conditions

Hypogonadism, Male

Kidney Disease, Chronic

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Jatenzo Pill

Study Details

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).

Conditions

Hypogonadism, Male

Kidney Disease, Chronic

Study ID

NCT05249634

Start date

Mar 15, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: treatment

JATENZO daily for 6 months

Interventions

Jatenzo Pill

oral tablet daily

Primary outcome measure

  • Testosterone concentrations [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sandeep Dhindsa, MD

314-977-9320sandeep.dhindsa@health.slu.edu

Jennifer Newman, RN

jennifer.newman@heath.slu.edu

Locations

Saint Louis Univeristy

Recruiting

St Louis, Missouri, United States, 63104

More Information

Sponsor

St. Louis University

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

  • testosterone
  • CKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Louis University on 2026-04-30.