Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

  • End date
    Oct 31, 2021
  • participants needed
  • sponsor
    University of California, San Diego
Updated on 17 February 2021


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.


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).

Condition Hormone replacement therapy, Chemotherapy, Renal function test, Renal Function, transgender, kidney function tests, renal function tests, renal function study, kidney function test, hormone replacement, menopausal hormone therapy, hormone replacement therapy (hrt)
Treatment Iohexol, IHX-CL measurements
Clinical Study IdentifierNCT04742816
SponsorUniversity of California, San Diego
Last Modified on17 February 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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