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OpenTrials
Completed

NCT Number: NCT04482920

Effect of Hormone Therapy on Renal Function

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

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Key information

Conditions

Transgenderism Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Injury Male Urogenital Diseases Sexual Behavior Sexuality Transsexualism Urogenital Diseases Urologic Diseases

Age range

17 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045', United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

p-aminohippurate clearance study

Diagnostic Test

To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.

Iohexol infusion

Diagnostic Test

To measure glomerular filtration rate (GFR)

Primary outcomes

  1. Change in measured glomerular filtration rate (GFR)

    Time frame: Baseline, 3 months

Secondary outcomes

  1. Change in effective renal plasma flow

    Time frame: Baseline, 3 months

  2. 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])

    Time frame: Baseline, 3 months

  3. Change in fat mass

    Time frame: Baseline, 3 months

    Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy

  4. Change in fat-free mass

    Time frame: Baseline, 3 months

    Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy

  5. Change in intracellular fluid

    Time frame: Baseline, 3 months

    Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy

  6. Change in extracellular fluid

    Time frame: Baseline, 3 months

    Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2020
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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