Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

Renal Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742816
• Other study ID #: CCTG 605s
• Status: Completed
• Phase: Phase 4
• Start date: September 17, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

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

Related Conditions & MeSH terms

• Hormone Replacement Therapy
• Renal Function
• Transgender

Intervention

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

Locations

Country	Name	City	State
United States	UC San Diego AntiViral Research Center (AVRC)	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	Blood concentration of tenofovir	Tenofovir concentrations in blood and blotted on dried blood spot cards.	Day 1