Testosterone Treatment in Men With Chronic Kidney Disease

Kidney Disease, Chronic Clinical Trial

Official title:

Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249634
• Other study ID #: 32358
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: St. Louis University
• Contact: Sandeep Dhindsa, MD
• Phone: 314-977-9320
• Email: sandeep.dhindsa[@]health.slu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Jatenzo Pill
oral tablet daily

Locations

Country	Name	City	State
United States	Saint Louis Univeristy	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	Clarus Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone concentrations	Testosterone concentrations in serum measured multiple times during the study	6 months
Secondary	Hemoglobin	blood test	6 months
Secondary	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.	6 months
Secondary	Lean mass	measured by DEXA scan	6 months
Secondary	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.	6 months