CClinicalTrials.gg
Sign In
TerminatedNCT02712944Updated May 28, 2019

Testosterone Replacement in Renal Failure

A Phase 1 interventional study of Testosterone and Saline in Hypogonadism, sponsored by Texas Tech University Health Sciences Center. Terminated at 1 site in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-28.

Sponsored by Texas Tech University Health Sciences Center · Phase 1, Interventional, and Treatment

Why this study was terminated
Study stopped for procedural difficulties and lack of personnel
Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Hypogonadism

Browse trials for

03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 21 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Active comparator
    Testosterone

    Testosterone intramuscular every 2 weeks

    Drug: Testosterone

  • Placebo comparator
    Saline

    Saline intramuscular every 2 weeks

    Drug: Saline

Interventions

  • DrugTestosterone

    Testosterone

  • DrugSaline

    Placebo

06

What researchers measure

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.

    Time frame: primary outcome will be measured at months 5 and 6.

07

Study locations

1 site
  • TTUHSC-Permian Basin
    Odessa, Texas 79763, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02712944
Lead sponsor
Texas Tech University Health Sciences Center
Responsible party
Sponsor
First posted
Mar 18, 2016
Start date
Jul 2016
Primary completion
Mar 2018
Completion
Mar 2018
Last update
May 28, 2019

Study contacts

Sandeep Dhindsa, MD
principal investigator · TTUHSC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypogonadism→

Other studies from this sponsor

Texas Tech University Health Sciences Center

Start the discussion