NCT04482920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2.4 years

First QC Date

June 26, 2020

Last Update Submit

May 1, 2024

Conditions

TransgenderismKidney DiseasesKidney Injury

Outcome Measures

Primary Outcomes (1)

  • Change in measured glomerular filtration rate (GFR)

    Baseline, 3 months

Secondary Outcomes (6)

  • 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

    Baseline, 3 months

  • Change in fat-free mass

    Baseline, 3 months

  • Change in intracellular fluid

    Baseline, 3 months

  • +1 more secondary outcomes

Study Arms (2)

Transgender males

Transgender males who are clinically ready to start testosterone

Diagnostic Test: p-aminohippurate clearance studyDiagnostic Test: Iohexol infusion

Transgender females

Transgender females who are clinically ready to start estradiol

Diagnostic Test: p-aminohippurate clearance studyDiagnostic Test: Iohexol infusion

Interventions

p-aminohippurate clearance studyDIAGNOSTIC_TEST

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

Transgender femalesTransgender males
Iohexol infusionDIAGNOSTIC_TEST

To measure glomerular filtration rate (GFR)

Transgender femalesTransgender males

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045', United States

Location

Related Publications (1)

  • van Eeghen SA, Pyle L, Narongkiatikhun P, Choi YJ, Obeid W, Parikh CR, Vosters TG, van Valkengoed IG, Krebber MM, Touw DJ, den Heijer M, Bjornstad P, van Raalte DH, Nokoff NJ. Unveiling mechanisms underlying kidney function changes during sex hormone therapy. J Clin Invest. 2025 Mar 25;135(9):e190850. doi: 10.1172/JCI190850. eCollection 2025 May 1.

    PMID: 40193283DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine

MeSH Terms

Conditions

TranssexualismKidney Diseases

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Natalie J Nokoff, MD, MSCS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 23, 2020

Study Start

April 15, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

US(1)