NCT04742816

Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients Sub-Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IHX-CL measurements	The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
DRUG	Iohexol	Iohexol clearance measurement

Timeline

• Start date: 2020-09-17
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-02-08
• Last updated: 2022-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study