Testosterone Treatment in Men With Chronic Kidney Disease

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).

Study Overview

• Status: Recruiting
• Conditions: Kidney Disease, Chronic; Hypogonadism, Male
• Intervention / Treatment: Drug: Jatenzo Pill

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sandeep Dhindsa, MD; Phone Number: 314-977-9320; Email: sandeep.dhindsa@health.slu.edu
• Study Contact Backup: Name: Jennifer Newman, RN; Email: jennifer.newman@heath.slu.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Recruiting
      • Saint Louis Univeristy
      • Contact: Jennifer Newman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; JATENZO daily for 6 months	Drug: Jatenzo Pill; oral tablet daily; Other Names: oral testosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosterone concentrations	Testosterone concentrations in serum measured multiple times during the study	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	blood test	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.	6 months
Lean mass	measured by DEXA scan	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.	6 months

Collaborators and Investigators

• Sponsor: St. Louis University
• Collaborators: Clarus Therapeutics
• Investigators: Principal Investigator: Sandeep Dhindsa, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CKD; testosterone
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Gonadal Disorders; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hypogonadism; Eunuchism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: 32358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No