TransgenderPhase 4NCT04742816
Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients
A Phase 4 study testing IHX-CL measurements and Iohexol in people with Transgender and Renal Function, run by University of California, San Diego at 1 site in United States.
Trial summary
Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Transgender, Renal Function, Hormone Replacement Therapy
- What is being tested?
- IHX-CL measurements and Iohexol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2020to 31 Dec 2021
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-uninfected
- Identifying as transgender or nonbinary (TG/NB)
- Age ≥ 18 years (adult)
- At risk of acquiring HIV
- Calculated creatinine clearance (CRCL) ≥ 60 mL/minute
- Taking emtricitabine/tenofovir alafenamide
- Willing to receive a small dose of iohexol
- Willing to provide 30 mL blood and a urine sample
Who cannot join
- Allergy to iohexol
- Use of concurrent medications that may interfere with iohexol such as metformin, amiodarone or beta-blockers
- Anuric or unable to produce 30 mL of urine
- Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego AntiViral Research Center (AVRC)
San Diego, California, 92103
About this study
Official title: Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study
Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.
Read the detailed description
This cross-sectional sub-study will use a subset of the main study cohort of transgender (TG) or non-binary (NB) individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values (serum estradiol, estrone, free/total testosterone), renal biomarkers, drug levels (measured by tenofovir diphosphate, TFV-DP, and emtricitabine triphosphate, FTC-TP, on dried blood spot cards and urine) and directly measured renal function (iohexol clearance).
- Conditions
- Transgender, Renal Function, Hormone Replacement Therapy
- Being tested
- IHX-CL measurements, Iohexol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHX-CL measurementsDiagnostic test
Also called OMNIPAQUE, Iohexol
The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
IohexolDrug
Also called OMNIPAQUE
Iohexol clearance measurement
| Study group | Role | What they receive |
|---|---|---|
| Iohexol injection | Other | The research pharmacist will prepare the iohexol injection in a 1cc tuberculin syringe, consisting of 0.5cc sterile water for injection (SWFI) and 0.5cc iohexol (Omnipaque 300). The study coordinator/personnel (licensed RN) will inject the iohexol dose into the subcutaneous tissue on the opposite arm used for blood sampling; the time will be recorded. The participant will be monitored for adverse events 30 minutes post iohexol administration at the AVRC. If the participant has not had any adverse event within 30 minutes, they will be asked to leave the AVRC and return within 2 hours and 55 minutes post Iohexol injection for lab collection. Receives: Diagnostic Test: IHX-CL measurements; Drug: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iohexol clearance
Rate of clearance (mL/min) of iohexol from the body after a small dose is administered subcutaneously. Iohexol clearance is the gold standard for measuring kidney function.
Measured: Day 1
Secondary outcomes (1)
Blood concentration of tenofovir
Tenofovir concentrations in blood and blotted on dried blood spot cards.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start17 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- iohexol
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimish Patel, University of California, San Diego
- Investigators
- Nimish Patel, PharmD, Principal investigator, UC San Diego AntiViral Research Center (AVRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742816
- Sponsor's protocol ID
- CCTG 605s
- Status last verified
- Mar 2022
- First submitted
- 25 Jan 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study
- ClinicalTrials.gov ID
- NCT04742816
- Acronym / sponsor ID
- CCTG 605s
- Conditions
- Transgender, Renal Function, Hormone Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- 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.
Will use a subset of the main study cohort of transgender or non-binary individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values, renal biomarkers, drug levels and directly measured renal function.
Detailed description
This cross-sectional sub-study will use a subset of the main study cohort of transgender (TG) or non-binary (NB) individuals to evaluate the relationships between self-reported exogenous hormone use, endogenous hormone values (serum estradiol, estrone, free/total testosterone), renal biomarkers, drug levels (measured by tenofovir diphosphate, TFV-DP, and emtricitabine triphosphate, FTC-TP, on dried blood spot cards and urine) and directly measured renal function (iohexol clearance).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- iohexol
| Arm | Type | Receives |
|---|---|---|
| Iohexol injection | Other | Diagnostic Test: IHX-CL measurements, Drug: IohexolThe research pharmacist will prepare the iohexol injection in a 1cc tuberculin syringe, consisting of 0.5cc sterile water for injection (SWFI) and 0.5cc iohexol (Omnipaque 300). The study coordinator/personnel (licensed RN) will inject the iohexol dose into the subcutaneous tissue on the opposite arm used for blood sampling; the time will be recorded. The participant will be monitored for adverse events 30 minutes post iohexol administration at the AVRC. If the participant has not had any adverse event within 30 minutes, they will be asked to leave the AVRC and return within 2 hours and 55 minutes post Iohexol injection for lab collection. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV-uninfected
- Identifying as transgender or nonbinary (TG/NB)
- Age ≥ 18 years (adult)
- At risk of acquiring HIV
- Calculated creatinine clearance (CRCL) ≥ 60 mL/minute
Key exclusion criteria (4 listed)
- Allergy to iohexol
- Use of concurrent medications that may interfere with iohexol such as metformin, amiodarone or beta-blockers
- Anuric or unable to produce 30 mL of urine
- Other condition that, in the opinion of the investigator, would put the participant at risk, complicate interpretation of study outcome data, or would otherwise interfere with participation or achieving the study objectives
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 |
|---|---|---|
| IHX-CL measurementsAlso: OMNIPAQUE, IohexolThe distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution. | Diagnostic test | Iohexol injection |
| IohexolAlso: OMNIPAQUEIohexol clearance measurement | Drug | Iohexol injection |
Primary outcome
Iohexol clearance
Time frame: Day 1
Rate of clearance (mL/min) of iohexol from the body after a small dose is administered subcutaneously. Iohexol clearance is the gold standard for measuring kidney function.
1 secondary outcome
Blood concentration of tenofovir
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- 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.
Nimish Patel, PharmD principal investigator
UC San Diego AntiViral Research Center (AVRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IHX-CL measurements and Iohexol in people with Transgender and Renal Function, run by University of California, San Diego 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Iohexol clearance (time frame: Day 1). 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 3 Mar 2022.