Testosterone Replacement in Renal Failure

Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02712944

Enrollment

Registered

2016-03-18

Start date

2016-07-31

Completion date

2018-03-31

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadism

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.

Interventions

DRUGTestosterone

Testosterone

DRUGSaline

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in dosage of Erythropoietin stimulating agents (ESA)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026