Effect of Hormone Therapy on Renal Function

The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth

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

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; Kidney Injury; Transgenderism
• Intervention / Treatment: Diagnostic test: p-aminohippurate clearance study; Diagnostic test: Iohexol infusion

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045'
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

20 transgender youth and young adults (10 transgender females, 10 transgender males) before and 3 months after initiation of gender affirming hormone therapy to determine the impact of gender affirming hormone therapy on intrarenal hemodynamic function and tubular function.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transgender males; Transgender males who are clinically ready to start testosterone	Diagnostic test: p-aminohippurate clearance study; To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.; Diagnostic test: Iohexol infusion; To measure glomerular filtration rate (GFR)
Transgender females; Transgender females who are clinically ready to start estradiol	Diagnostic test: p-aminohippurate clearance study; To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.; Diagnostic test: Iohexol infusion; To measure glomerular filtration rate (GFR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in measured glomerular filtration rate (GFR)	Baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in effective renal plasma flow		Baseline, 3 months
Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40])		Baseline, 3 months
Change in fat mass	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months
Change in fat-free mass	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months
Change in intracellular fluid	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months
Change in extracellular fluid	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Natalie J Nokoff, MD, MSCS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases
• Other Study ID Numbers: 20-0572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No