Status:
COMPLETED
Effect of Hormone Therapy on Renal Function
Lead Sponsor:
University of Colorado, Denver
Conditions:
Transgenderism
Kidney Diseases
Eligibility:
All Genders
17-30 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04482920
Start Date
April 15 2021
End Date
August 31 2023
Last Update
May 3 2024
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045'