Testosterone Replacement in Renal Failure

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

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.

Study Overview

• Status: Terminated
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: Saline; Drug: Testosterone

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Odessa, Texas, United States, 79763
      • TTUHSC-Permian Basin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Testosterone; Testosterone intramuscular every 2 weeks	Drug: Testosterone; Testosterone
Placebo Comparator: Saline; Saline intramuscular every 2 weeks	Drug: Saline; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Sandeep Dhindsa, MD, TTUHSC

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (Estimate): March 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: L16-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO