Testosterone Replacement in Renal Failure

NCT02712944 | Terminated Phase 1

• 1 other identifier: L16-079
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Testosterone

ACTIVE COMPARATOR

Testosterone intramuscular every 2 weeks

Drug: Testosterone

Saline

PLACEBO COMPARATOR

Saline intramuscular every 2 weeks

Drug: Saline

Interventions

Testosterone DRUG

Testosterone

Testosterone

Saline DRUG

Placebo

Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

TTUHSC-Permian Basin

Odessa, Texas, 79763, United States

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; Sodium Chloride

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sandeep Dhindsa, MD

  TTUHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 18, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)