Effect of Hormone Therapy on Renal Function

Completed

• Conditions: Transgenderism; Kidney Diseases; Kidney Injury
• Interventions: Diagnostic Test: p-aminohippurate clearance study; Diagnostic Test: Iohexol infusion

• Registration Number: NCT04482920
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-23
• Study Start: 2021-04-15
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transgender males	p-aminohippurate clearance study	Transgender males who are clinically ready to start testosterone
Transgender males	Iohexol infusion	Transgender males who are clinically ready to start testosterone
Transgender females	p-aminohippurate clearance study	Transgender females who are clinically ready to start estradiol
Transgender females	Iohexol infusion	Transgender females who are clinically ready to start estradiol

Primary Outcome Measures

Name	Time	Method
Change in measured glomerular filtration rate (GFR)	Baseline, 3 months

Secondary Outcome Measures

Name	Time	Method
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 intracellular fluid	Baseline, 3 months	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Change in fat mass	Baseline, 3 months	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Change in fat-free mass	Baseline, 3 months	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Change in extracellular fluid	Baseline, 3 months	Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States