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Testosterone Replacement in Renal Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02712944
Recruitment Status : Terminated (Study stopped for procedural difficulties and lack of personnel)
First Posted : March 18, 2016
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Testosterone Drug: Saline Phase 1

Detailed Description:
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients
Study Start Date : July 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Testosterone
Testosterone intramuscular every 2 weeks
Drug: Testosterone
Testosterone

Placebo Comparator: Saline
Saline intramuscular every 2 weeks
Drug: Saline
Placebo




Primary Outcome Measures :
  1. Change in dosage of Erythropoietin stimulating agents (ESA) [ Time Frame: primary outcome will be measured at months 5 and 6. ]
    Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men between ages of 18-80 years of age.
  2. Renal failure on hemodialysis
  3. Free testosterone <5 ng/dl.
  4. Willing to be randomized to intramuscular (IM) testosterone or placebo
  5. Currently getting intravenous Epoetin alfa

Exclusion Criteria:

  1. Use of testosterone treatment currently or in the past 6 months, including use of over the counter androgen containing health supplements.
  2. Congestive heart Failure, class III or IV.
  3. Baseline hemoglobin of > 12 g/dl.
  4. Allergic reactions to testosterone Vehicle (i.e. Peanut oil)
  5. prostate specific antigen>4 ng/ml.
  6. History of Prostate Cancer.
  7. Liver enzymes >twice the upper limit of normal.
  8. HIV or hepatitis C.
  9. Severe untreated obstructive sleep apnea (defined as apnea-hypopnea index> 30).
  10. Subjects on warfarin or other blood thinners.
  11. Active infection (such as foot ulcer)
  12. History of adverse events with testosterone use in past.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712944


Locations
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United States, Texas
TTUHSC-Permian Basin
Odessa, Texas, United States, 79763
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Sandeep Dhindsa, MD TTUHSC
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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02712944    
Other Study ID Numbers: L16-079
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs