Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in dosage of Erythropoietin stimulating agents (ESA)
Study Overview
Brief 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.
Detailed Description
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Testosterone
Testosterone intramuscular every 2 weeks
Intervention: Testosterone (Drug)
Saline
Saline intramuscular every 2 weeks
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Change in dosage of Erythropoietin stimulating agents (ESA)
Time Frame: primary outcome will be measured at months 5 and 6.
Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.
Secondary Outcomes
No secondary outcomes reported