Testosterone Replacement in Renal Failure



Status:Recruiting
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 80
Updated:1/10/2019
Start Date:July 2016
End Date:December 2019
Contact:Catherine J Lovett, RN
Email:cathy.lovett@ttuhsc.edu
Phone:806.743.4433

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Trial Summary
Trial Overview
Inclusion Criteria

Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients

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.

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

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.
We found this trial at
1
site
TTUHSC-Permian Basin
Odessa, Texas 79763
?
mi
from
Odessa, TX
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