RECRUITING

Testosterone Treatment in Men With Chronic Kidney Disease

Conditions

Hypogonadism, Male Kidney Disease, Chronic testosterone CKD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-03-15

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05249634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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%.	* 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

Inclusion Criteria

Exclusion 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%.

* 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

Contacts and Locations

Study Contact

Sandeep Dhindsa, MD

CONTACT

314-977-9320

sandeep.dhindsa@health.slu.edu

Jennifer Newman, RN

CONTACT

jennifer.newman@heath.slu.edu

Principal Investigator

Sandeep Dhindsa, MD

PRINCIPAL_INVESTIGATOR

St. Louis University

Study Locations (Sites)

Saint Louis Univeristy

Saint Louis, Missouri, 63104

United States

Collaborators and Investigators

Sponsor: St. Louis University

Sandeep Dhindsa, MD, PRINCIPAL_INVESTIGATOR, St. Louis University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-15

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-03-15

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

testosterone
CKD

Additional Relevant MeSH Terms

Hypogonadism, Male
Kidney Disease, Chronic