Testosterone Replacement in Renal Failure

Texas Tech University Health Sciences Center

Status and phase: Terminated; Phase 1

Conditions: Hypogonadism

Treatments: Drug: Testosterone; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02712944

L16-079

Details and patient eligibility

About

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.

Full description

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

Enrollment: 21 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Testosterone

Active Comparator group

Description:

Testosterone intramuscular every 2 weeks

Treatment:

Drug: Testosterone

Saline

Placebo Comparator group

Description:

Saline intramuscular every 2 weeks

Treatment:

Drug: Saline