Back to resultsTestosterone Replacement in Renal Failure
Primary Purpose
Hypogonadism
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Testosterone
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism
Eligibility Criteria
Inclusion Criteria:
- Men between ages of 18-80 years of age.
- Renal failure on hemodialysis
- Free testosterone <5 ng/dl.
- Willing to be randomized to intramuscular (IM) testosterone or placebo
- Currently getting intravenous Epoetin alfa
Exclusion Criteria:
- Use of testosterone treatment currently or in the past 6 months, including use of over the counter androgen containing health supplements.
- Congestive heart Failure, class III or IV.
- Baseline hemoglobin of > 12 g/dl.
- Allergic reactions to testosterone Vehicle (i.e. Peanut oil)
- prostate specific antigen>4 ng/ml.
- History of Prostate Cancer.
- Liver enzymes >twice the upper limit of normal.
- HIV or hepatitis C.
- Severe untreated obstructive sleep apnea (defined as apnea-hypopnea index> 30).
- Subjects on warfarin or other blood thinners.
- Active infection (such as foot ulcer)
- History of adverse events with testosterone use in past.
Sites / Locations
- TTUHSC-Permian Basin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Testosterone
Saline
Arm Description
Testosterone intramuscular every 2 weeks
Saline intramuscular every 2 weeks
Outcomes
Primary Outcome Measures
Change in dosage of Erythropoietin stimulating agents (ESA)
Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.
Secondary Outcome Measures
Full Information
NCT ID
NCT02712944
First Posted
March 9, 2016
Last Updated
May 23, 2019
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT02712944
Brief Title
Testosterone Replacement in Renal Failure
Official Title
Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Study stopped for procedural difficulties and lack of personnel
Study Start Date
July 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to evaluate the effect of testosterone replacement in men with renal failure (on dialysis) who also have low testosterone. Specifically, the investigators will assess the change in requirement of Erythropoietin Stimulating agents.
Detailed Description
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Testosterone
Arm Type
Active Comparator
Arm Description
Testosterone intramuscular every 2 weeks
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline intramuscular every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Testosterone
Intervention Description
Testosterone
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in dosage of Erythropoietin stimulating agents (ESA)
Description
Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.
Time Frame
primary outcome will be measured at months 5 and 6.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men between ages of 18-80 years of age.
Renal failure on hemodialysis
Free testosterone <5 ng/dl.
Willing to be randomized to intramuscular (IM) testosterone or placebo
Currently getting intravenous Epoetin alfa
Exclusion Criteria:
Use of testosterone treatment currently or in the past 6 months, including use of over the counter androgen containing health supplements.
Congestive heart Failure, class III or IV.
Baseline hemoglobin of > 12 g/dl.
Allergic reactions to testosterone Vehicle (i.e. Peanut oil)
prostate specific antigen>4 ng/ml.
History of Prostate Cancer.
Liver enzymes >twice the upper limit of normal.
HIV or hepatitis C.
Severe untreated obstructive sleep apnea (defined as apnea-hypopnea index> 30).
Subjects on warfarin or other blood thinners.
Active infection (such as foot ulcer)
History of adverse events with testosterone use in past.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Dhindsa, MD
Organizational Affiliation
TTUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
TTUHSC-Permian Basin
City
Odessa
State/Province
Texas
ZIP/Postal Code
79763
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Testosterone Replacement in Renal Failure
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