Renal Effects of Hormones/Biomarkers in Transgender PrEP Recipients

NCT04742816 | Completed Phase 4 FDA Drug

• 1 other identifier: CCTG 605s
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Transgender; Renal Function; Hormone Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood concentration of tenofovir

  Day 1

Study Arms (1)

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.

Diagnostic Test: IHX-CL measurements; Drug: Iohexol

Interventions

IHX-CL measurements DIAGNOSTIC_TEST

The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.

Also known as: OMNIPAQUE, Iohexol

Iohexol injection

Iohexol DRUG

Iohexol clearance measurement

Also known as: OMNIPAQUE

Iohexol injection

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

Location

MeSH Terms

Interventions

Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nimish Patel, PharmD

  UC San Diego AntiViral Research Center (AVRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Clinical

Model Details: iohexol

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 8, 2021
• Study Start: September 17, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)