Testosterone Replacement in Renal Failure

• Status: Terminated
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Tech University Health Sciences Center
• Treatments: Epoetin Alfa; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.