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Recruiting NCT05249634

Testosterone Treatment in Men With Chronic Kidney Disease

Phase II Interventional Hypogonadism, Male Kidney Disease, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Jatenzo Pill.
Who it may be relevant to
Registry conditions: Hypogonadism, Male, Kidney Disease, Chronic. Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Jatenzo Pill
    oral tablet daily

Primary outcome measures

  • Testosterone concentrations [Time frame: 6 months]
Secondary outcome measures (4)
  • Hemoglobin [Time frame: 6 months]
  • muscle strength [Time frame: 6 months]
  • Lean mass [Time frame: 6 months]
  • sexual function [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Saint Louis Univeristy — St Louis

Identifiers

NCT: NCT05249634 · 32358

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗