Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742816
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2021-01-25
Brief Title:
Renal Effects of HormonesBiomarkers in Transgender PrEP Recipients
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Renal Effects of HormonesBiomarkers in Transgender PrEP Recipients Sub-Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 freetotal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None