HypogonadismPhase 1NCT02712944
Testosterone Replacement in Renal Failure
A Phase 1 study testing Testosterone and Saline in people with Hypogonadism, run by Texas Tech University Health Sciences Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.
- Conditions
- Hypogonadism
- Being tested
- Testosterone, Saline
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Testosterone
SalineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Active comparator | Testosterone intramuscular every 2 weeks Receives: Drug: Testosterone |
| Saline | Placebo comparator | Saline intramuscular every 2 weeks Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: primary outcome will be measured at months 5 and 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Study stopped for procedural difficulties and lack of personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandeep Dhindsa, MD, Principal investigator, TTUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712944
- Sponsor's protocol ID
- L16-079
- Status last verified
- May 2019
- First submitted
- 9 Mar 2016
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Testosterone Replacement on Erythropoietin Stimulating Agent Use in End Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT02712944
- Acronym / sponsor ID
- L16-079
- Conditions
- Hypogonadism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped for procedural difficulties and lack of personnel
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Testosterone replacement can increase hemoglobin count. This can therefore decrease the requirement of Erythropoietin Stimulating agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Active comparator | Drug: TestosteroneTestosterone intramuscular every 2 weeks |
| Saline | Placebo comparator | Drug: SalineSaline intramuscular every 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneTestosterone | Drug | Testosterone |
| SalinePlacebo | Drug | Saline |
Primary outcome
Change in dosage of Erythropoietin stimulating agents (ESA)
Time frame: primary outcome will be measured at months 5 and 6.
Comparison of dose of ESA in the 2 months prior to the start of the drug and in months 5 and 6.
Results and safety
The study was stopped early (reason given: Study stopped for procedural difficulties and lack of personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep Dhindsa, MD principal investigator
TTUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone and Saline in people with Hypogonadism, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped for procedural difficulties and lack of personnel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dosage of Erythropoietin stimulating agents (ESA) (time frame: primary outcome will be measured at months 5 and 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.