Testosterone Replacement in Renal Failure

Recruiting in Palo Alto (17 mi)

Overseen by Sandeep Dhindsa, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Texas Tech University Health Sciences Center

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sandeep Dhindsa, MD

Principal Investigator

TTUHSC

Eligibility Criteria

Inclusion Criteria

Men between ages of 18-80 years of age.

Renal failure on hemodialysis

Free testosterone <5 ng/dl.

Treatment Details

Interventions

• Testosterone (Hormone Therapy)

Participant Groups

Group I: Testosterone Active Control 1 Intervention

Testosterone intramuscular every 2 weeks

Group II: Saline Placebo Group 1 Intervention

Saline intramuscular every 2 weeks

Testosterone is already approved in Canada, Japan for the following indications:

Approved in Canada as Testosterone for:

• Hypogonadism
• Delayed puberty
• Breast cancer palliation

Approved in Japan as Testosterone for:

• Hypogonadism
• Delayed puberty

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Dr. Lori Rice-Spearman

Texas Tech University Health Sciences Center

Chief Executive Officer since 2020

PhD in Clinical Laboratory Sciences from Texas Tech University

Dr. Steven Hanish

Texas Tech University Health Sciences Center

Chief Medical Officer since 2020

MD