Hypogonadism, MalePhase 2NCT05249634
Testosterone Treatment in Men With Chronic Kidney Disease
A Phase 2 study testing Jatenzo Pill in people with Hypogonadism, Male and Kidney Disease, Chronic, run by St. Louis University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Hypogonadism, Male, Kidney Disease, Chronic
- What is being tested?
- Jatenzo Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Newman, RN contact
United States1 site, 1 recruiting
- Recruiting
Saint Louis Univeristy
St Louis, Missouri, 63104
Jennifer Newman
About this study
Official title: Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease
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.
- Conditions
- Hypogonadism, Male, Kidney Disease, Chronic
- Being tested
- Jatenzo Pill
- Keywords
- testosterone, CKD
- Medical subject headings
- Eunuchism, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jatenzo PillDrug
Also called oral testosterone
oral tablet daily
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | JATENZO daily for 6 months Receives: Drug: Jatenzo Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testosterone concentrations
Testosterone concentrations in serum measured multiple times during the study
Measured: 6 months
Secondary outcomes (4)
Hemoglobin
blood test
Measured: 6 months
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.
Measured: 6 months
Lean mass
measured by DEXA scan
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start15 Mar 2022
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive treatment with JATENZO
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Clarus Therapeutics, Inc.
- Responsible party
- Principal investigator, Sandeep Singh Dhindsa, M.D., St. Louis University
- Investigators
- Sandeep Dhindsa, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249634
- Sponsor's protocol ID
- 32358
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2022
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No