Testosterone Replacement in Renal Failure

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Hypogonadism

In brief

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.

Key facts

Study ID

NCT02712944

Run by

Texas Tech University Health Sciences Center

People needed

21

Starts

2016-07-01

Expected to finish

2018-03-01

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• TTUHSC-Permian Basin — Odessa, Texas, United States

Full record on ClinicalTrials.gov

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