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Testosterone Treatment in Men With Chronic Kidney Disease

Primary Purpose

Hypogonadism, Male, Kidney Disease, Chronic

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Jatenzo Pill
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypogonadism, Male focused on measuring testosterone, CKD

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Louis UniveristyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

JATENZO daily for 6 months

Outcomes

Primary Outcome Measures

Testosterone concentrations
Testosterone concentrations in serum measured multiple times during the study

Secondary Outcome Measures

Hemoglobin
blood test
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.
Lean mass
measured by DEXA scan
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.

Full Information

First Posted
February 1, 2022
Last Updated
March 11, 2023
Sponsor
St. Louis University
Collaborators
Clarus Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05249634
Brief Title
Testosterone Treatment in Men With Chronic Kidney Disease
Official Title
Effect of JATENZO® Therapy on Testosterone and Hemoglobin Concentrations in Hypogonadal Men With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
Clarus Therapeutics

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Male, Kidney Disease, Chronic
Keywords
testosterone, CKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive treatment with JATENZO
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
JATENZO daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Jatenzo Pill
Other Intervention Name(s)
oral testosterone
Intervention Description
oral tablet daily
Primary Outcome Measure Information:
Title
Testosterone concentrations
Description
Testosterone concentrations in serum measured multiple times during the study
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hemoglobin
Description
blood test
Time Frame
6 months
Title
muscle strength
Description
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
Title
Lean mass
Description
measured by DEXA scan
Time Frame
6 months
Title
sexual function
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep Dhindsa, MD
Phone
314-977-9320
Email
sandeep.dhindsa@health.slu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Newman, RN
Email
jennifer.newman@heath.slu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Dhindsa, MD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis Univeristy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Newman

12. IPD Sharing Statement

Plan to Share IPD
No

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Testosterone Treatment in Men With Chronic Kidney Disease

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