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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
eGFR 15-45 ml/min/1.73m2 by MDRD (Modification of Diet in Renal Disease) equation
Men between ages of 18-85 years of age
Must not have
Initiated iron replacement in the last 3 months
Untreated, severe obstructive sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
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.
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 belowSelect...
My kidney function is moderately to severely reduced.
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I am a man aged between 18 and 85.
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My morning testosterone levels were below 300 ng/dl twice.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I started iron replacement therapy within the last 3 months.
Select...
I have severe sleep apnea that hasn't been treated.
Select...
My heart condition severely limits my daily activities.
Select...
I have had deep vein clots or lung clots more than once.
Select...
I have a history of prostate cancer.
Select...
I am being treated with drugs to help increase my red blood cells.
Select...
I am taking warfarin.
Select...
I have HIV or untreated hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Testosterone concentrations
Secondary study objectives
Hemoglobin
Lean mass
muscle strength
+1 moreAwards & 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
41,003 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a blood clot in my veins or lungs in the last 3 months.My kidney function is moderately to severely reduced.I have used testosterone replacement therapy or androgen supplements in the last 6 months.I started iron replacement therapy within the last 3 months.Your hematocrit level is higher than 48%.Your blood pressure is not well controlled and is very high.I have breast cancer.I have not had a heart attack, stroke, or heart surgery in the last 3 months.I am a man aged between 18 and 85.I have severe sleep apnea that hasn't been treated.You plan to have a baby in the next year.My heart condition severely limits my daily activities.I have had deep vein clots or lung clots more than once.I have a history of prostate cancer.I am being treated with drugs to help increase my red blood cells.My morning testosterone levels were below 300 ng/dl twice.Your blood test shows that you have enough iron in your body.I experience symptoms like low sex drive, mood changes, and changes in my body composition.Your PSA level is higher than 4 ng/ml, unless a urologist has confirmed that you don't have prostate cancer (and this is written in your medical notes).I experience symptoms like low sex drive, mood changes, and changes in my body composition.I am taking warfarin.I have HIV or untreated hepatitis C.Your blood iron levels are within a certain range: ferritin is at least 100 ng/mL and transferrin saturation is at least 20%.
Research Study Groups:
This trial has the following groups:- Group 1: treatment
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Testicular Hypogonadism Patient Testimony for trial: Trial Name: NCT05249634 — Phase 2
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