Testosterone Replacement in Renal Failure

Phase 1TerminatedNCT02712944

Texas Tech University Health Sciences Center21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypogonadism

Interventions

TestosteroneDRUG

Testosterone

SalineDRUG

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

TTUHSC-Permian Basin

Odessa, Texas, United States

Outcomes

Primary Outcomes

Change in dosage of Erythropoietin stimulating agents (ESA)

Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.

Time frame: primary outcome will be measured at months 5 and 6.

Data from ClinicalTrials.gov

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