← Back to Search

Androgen

Testosterone Treatment for Chronic Kidney Disease

Phase 2
Recruiting
Led By Sandeep Dhindsa, MD
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Study Summary

This trial is testing the effectiveness of a testosterone supplement in men with low testosterone and kidney disease.

Who is the study for?
Men aged 18-85 with low testosterone and chronic kidney disease (eGFR 15-45 ml/min/1.73m2) can join this trial. They should have symptoms like low sex drive, mood changes, or loss of muscle. Men on warfarin, those who've had recent heart issues or blood clots, or with untreated severe conditions are excluded.Check my eligibility
What is being tested?
The study is testing Jatenzo Pill's effect on men with low testosterone and kidney disease to see if it improves their hormone levels and red blood cell count.See study design
What are the potential side effects?
Possible side effects of Jatenzo may include increased risk of cardiovascular events like heart attack or stroke, liver problems, high blood pressure, enlarged prostate symptoms, potential for worsening sleep apnea, and changes in cholesterol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 18 and 85.
Select...
My kidney function is moderately to severely reduced.
Select...
My morning testosterone levels were low on two tests.
Select...
I am a man aged between 18 and 85.
Select...
I experience symptoms like low sex drive, mood changes, and changes in my body composition.
Select...
My kidney function is moderately to severely reduced.
Select...
My morning testosterone levels were below 300 ng/dl twice.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Testosterone concentrations
Secondary outcome measures
Hemoglobin
Lean mass
muscle strength
+1 more

Side effects data

From 2012 Phase 4 trial • 22 Patients • NCT01208038
19%
Skin irritation
10%
Increased facial hair
5%
per vagina spotting
5%
Acne
5%
Blepharitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testosterone

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 Intervention
JATENZO daily for 6 months

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,385 Total Patients Enrolled
Clarus TherapeuticsUNKNOWN
2 Previous Clinical Trials
71 Total Patients Enrolled
Sandeep Dhindsa, MDPrincipal InvestigatorSt. Louis University
5 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Jatenzo (Androgen) Clinical Trial Eligibility Overview. Trial Name: NCT05249634 — Phase 2
Testicular Hypogonadism Research Study Groups: treatment
Testicular Hypogonadism Clinical Trial 2023: Jatenzo Highlights & Side Effects. Trial Name: NCT05249634 — Phase 2
Jatenzo (Androgen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05249634 — Phase 2
Testicular Hypogonadism Patient Testimony for trial: Trial Name: NCT05249634 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled appointments in this research project?

"The trial, which is currently ongoing, was first posted on March 15th, 2022 and has since been updated."

Answered by AI

If I enroll, am I allowed to finish the whole program?

"This study, which is looking for 20 participants, requires that patients have hypogonadism and be between 18-85 years old."

Answered by AI

Will this experiment be testing seniors over the age of 70?

"Eligibility for this particular clinical trial is restricted to patients aged between 18 and 85. In contrast, there are 46 other trials available for minors and 495 targeting a senior demographic."

Answered by AI

Did the FDA sign off on Jatenzo Pill?

"Jatenzo Pill's safety is estimated to be a 2. Although there is no data currently supporting efficacy, there are Phase 2 trial results indicating that Jatenzo is safe for human use."

Answered by AI

How many people are recruited for this clinical trial at most?

"That is correct, the online clinicaltrials.gov registry currently lists this trial as open and recruiting patients. This particular study was posted on March 15th, 2022 and edited on the same day. There is a total of 20 spots available for participants at a single location."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Virginia
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Saint Louis Univeristy
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

To correct a problem.
PatientReceived 1 prior treatment
~3 spots leftby Jun 2024