Clinical trial NCT05249634: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypogonadism, Male
Kidney Disease, Chronic
Keywords: testosterone
CKD
Lead sponsor: St. Louis University
Sponsor class: OTHER
Collaborators: name: Clarus Therapeutics, Inc.
First posted: 2022-02-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive treatment with JATENZO
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Testosterone concentrations
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin
timeFrame: 6 months
measure: muscle strength
timeFrame: 6 months
measure: Lean mass
timeFrame: 6 months
measure: sexual function
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Saint Louis Univeristy
state: Missouri
Study officials:
affiliation: St. Louis University
name: Sandeep Dhindsa, MD
role: PRINCIPAL_INVESTIGATOR
References: