Testosterone Replacement in Renal Failure

Hypogonadism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02712944
• Other study ID #: L16-079
• Status: Terminated
• Phase: Phase 1
• Start date: July 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2019
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testosterone
Testosterone
• Saline
Placebo

Locations

Country	Name	City	State
United States	TTUHSC-Permian Basin	Odessa	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	primary outcome will be measured at months 5 and 6.