Testosterone Treatment in Men With Chronic Kidney Disease

NCT05249634 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 32358
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypogonadism, Male; Kidney Disease, Chronic

Keywords

testosterone; CKD

Outcome Measures

Primary Outcomes (1)

• Testosterone concentrations

  Testosterone concentrations in serum measured multiple times during the study

  6 months

Secondary Outcomes (4)

• Hemoglobin

  6 months

• muscle strength

  6 months

• Lean mass

  6 months

• sexual function

  6 months

Study Arms (1)

treatment

EXPERIMENTAL

JATENZO daily for 6 months

Drug: Jatenzo Pill

Interventions

Jatenzo Pill DRUG

oral tablet daily

Also known as: oral testosterone

treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• Clarus Therapeutics, Inc.: collaborator

Study Sites (1)

Saint Louis Univeristy

St Louis, Missouri, 63104, United States

RECRUITING

MeSH Terms

Conditions

Eunuchism; Renal Insufficiency, Chronic

Interventions

Testosterone Propionate; Testosterone

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sandeep Dhindsa, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandeep Dhindsa, MD

CONTACT

314-977-9320; sandeep.dhindsa@health.slu.edu

Jennifer Newman, RN

CONTACT

jennifer.newman@heath.slu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: All subjects will receive treatment with JATENZO

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 21, 2022
• Study Start: March 15, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)