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RecruitingNCT05249634Updated Apr 30, 2026

Testosterone Treatment in Men With Chronic Kidney Disease

A Phase 2 interventional study of Jatenzo Pill in Hypogonadism, Male and Kidney Disease, Chronic, sponsored by St. Louis University. Recruiting at 1 site in United States. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by St. Louis University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
Male
01

Study 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).

Read the detailed description
  • Purpose. The purpose of this research is to find out if JATENZO will help increase testosterone levels in men with hypogonadism and chronic kidney disease, determine if there is any improvement in testosterone levels, hemoglobin (red blood cells), muscle strength, lean mass and sexual function.
  • The dug will be daily for 6 months. Study Procedures. Every 2-4 weeks, the study participant will come in person for a research visit. Investigators will collect a blood sample at certain visits, do a brief physical exam, and obtain vital signs such as height, weight, blood pressure. The study also involves completing questionnaires, measuring body composition by a scan and testing muscle strength. The dose of JATENZO may be adjusted based on the testosterone levels.
02

Conditions studied

  • Hypogonadism, Male
  • Kidney Disease, Chronic

Keywords

  • testosterone
  • CKD
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    treatment

    JATENZO daily for 6 months

    Drug: Jatenzo Pill

Interventions

  • DrugJatenzo Pill

    oral tablet daily

    Also known as: oral testosterone

05

What researchers measure

Primary outcomes

  1. Testosterone concentrations

    Testosterone concentrations in serum measured multiple times during the study

    Time frame: 6 months

Secondary outcomes

  1. Hemoglobin

    blood test

    Time frame: 6 months

  2. muscle strength

    Hand-grip strength will be measured by a quantitative handgrip dynamometer in the dominant arm. Mean of three consecutive measurements will be used.

    Time frame: 6 months

  3. Lean mass

    measured by DEXA scan

    Time frame: 6 months

  4. sexual function

    Psychosexual daily questionnaire for 7 consecutive days will be used. The questionnaire covers three different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual desire (question 1) and sexual enjoyment (question 2) will be rated on a 7-point Likert-type scale from 0 to 7, with 0 indicating none and 7 indicating very high. Sexual performance will be assessed by % full erection and satisfaction with erection (questions 5 and 6). Sexual activity (question 4) will be assessed using a checklist format. The value will be recorded as 0 (none) or 1 (any) for analysis. Higher score indicates higher activity; maximum score on this item is 12. Each mood parameter (question 3) will also be assessed on the 7-point Likert scale.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Saint Louis Univeristy
    St Louis, Missouri 63104, United States
    • Jennifer Newman · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05249634
Lead sponsor
St. Louis University
Collaborators
Clarus Therapeutics, Inc.
Responsible party
Sandeep Singh Dhindsa, M.D. (Professor of Medicine, St. Louis University) — Principal investigator
First posted
Feb 21, 2022
Start date
Mar 15, 2022
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Apr 30, 2026

Study contacts

Sandeep Dhindsa, MD
Contact
sandeep.dhindsa@health.slu.edu
314-977-9320
Jennifer Newman, RN
Contact
jennifer.newman@heath.slu.edu
Sandeep Dhindsa, MD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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