Testosterone Replacement in Renal Failure

Phase 1

Terminated

• Conditions: Hypogonadism
• Interventions: Drug: Saline; Drug: Testosterone

• Registration Number: NCT02712944
• Lead Sponsor: Texas Tech University Health Sciences Center

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 Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-18
• Study Start: 2016-07
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline intramuscular every 2 weeks
Testosterone	Testosterone	Testosterone intramuscular every 2 weeks

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

TTUHSC-Permian Basin; 🇺🇸 Odessa, Texas, United States