Effect of Hormone Therapy on Renal Function

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04482920
• Other study ID #: 20-0572
• Status: Recruiting
• Start date: February 15, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: Natalie J Nokoff, MD, MSCS
• Phone: 720-777-6128
• Email: Natalie.Nokoff[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Gender: All
• Age group: 17 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Injury
• Transgenderism

Intervention

Diagnostic Test:
• p-aminohippurate clearance study
To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.
• Iohexol infusion
To measure glomerular filtration rate (GFR)

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measured glomerular filtration rate (GFR)		Baseline, 3 months
Secondary	Change in effective renal plasma flow		Baseline, 3 months
Secondary	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
Secondary	Change in fat mass	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months
Secondary	Change in fat-free mass	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months
Secondary	Change in intracellular fluid	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months
Secondary	Change in extracellular fluid	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy	Baseline, 3 months