Effect of Hormone Therapy on Renal Function

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Kidney Diseases; Kidney Injury; Transgenderism

Treatments: Diagnostic Test: p-aminohippurate clearance study; Diagnostic Test: Iohexol infusion

Study type: Observational

Funder types: Other

Identifiers

NCT04482920

20-0572

Details and patient eligibility

About

The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.

Enrollment: 22 patients

Sex: All

Ages: 17 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Identify as transgender
• Age 17-30 years (inclusive)
• Plan to start gender affirming hormone therapy (testosterone or estradiol) clinically in ≤ 1 months and remain on for at least 3 months

Exclusion criteria

• Cognitive, psychiatric or physical impairment resulting in inability to tolerate the study procedures (e.g. intellectual disability, schizophrenia, hallucinations)
• Type 1 or Type 2 diabetes
• Chronic kidney disease, or eGFR <60ml/min/1.73m2 by CKD-EPI formulation
• Uncontrolled hypertension (resting BP ≥ 140/90 mm/Hg)
• Allergy to shellfish, iodine or iohexol
• Currently taking: sulfonamides, procaine, thiazolesulfone and probenecid (renal clearance measurements of PAH cannot be made accurately if individuals are on these medications)
• Prior gender affirming hormone therapy use
• Prior gonadectomy
• Pregnancy

Trial design

22 participants in 2 patient groups

Transgender males

Description:

Transgender males who are clinically ready to start testosterone

Treatment:

Diagnostic Test: p-aminohippurate clearance study

Diagnostic Test: Iohexol infusion

Transgender females

Description:

Transgender females who are clinically ready to start estradiol

Treatment:

Diagnostic Test: p-aminohippurate clearance study

Diagnostic Test: Iohexol infusion