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Sex Hormones and Kidney Function in Gender-Affirming Hormone Therapy, 60 Participants

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Summary

The National Institutes of Health registered observational study NCT07542964 on April 21, 2026, investigating how sex hormones affect kidney function in individuals undergoing gender-affirming hormone therapy. The study will enroll 60 participants (30 men and 30 women, aged 18-40) who will undergo three study visits over one year, including kidney function measurements, kidney MRI, urine collection, and fat tissue sampling. Participants will not experience delays in starting gender-affirming hormone therapy.

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What changed

NIH has registered a new observational clinical study on ClinicalTrials.gov. Study NCT07542964 examines the mechanisms by which testosterone and estradiol influence kidney function in individuals beginning gender-affirming hormone therapy, with the goal of understanding sex-based differences in kidney disease progression.

Healthcare providers offering gender-affirming hormone therapy and individuals considering such treatment may benefit from awareness of this research. Patients enrolled in the study will not have their therapy initiation delayed, and two of three study visits coincide with scheduled healthcare appointments.

Archived snapshot

Apr 21, 2026

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Transgender Analysis of Nephrological Studies Focused on Renal Metrics

Observational NCT07542964 Kind: OBSERVATIONAL Apr 21, 2026

Abstract

This study investigates how sex hormones affect kidney function in people undergoing gender-affirming hormone therapy (GAHT). We know men have a faster progression of kidney disease. Earlier studies suggest that the female sex hormone estradiol may have a protective effect on kidney function while the male sex hormone testosterone may have the opposite effect. But the reasons why this happens remain unclear. By studying participants undergoing (GAHT) we gain insight into the mechanisms by which testosterone and estradiol influence the kidneys. People undergoing GAHT provide a unique chance to study how sex hormones interact with the kidneys. The results may help us to understand why men and women exhibit differences in kidney disease development. This study will include 30 men and 30 women, aged 18 to 40, who start GAHT. Participants will have three study visits, two of which will happen during their scheduled healthcare appointments. During the first visit, a screening will take place to check if patients can take part in the study. At study visits before and after one year of therapy, kidney function is measured, kidney MRI is performed, urine is collected and a small sample of fat tissue. Taking part in the study does not delay the start of GAHT.

Conditions: Kidney Disease, Kidney Injury, Transgender Individuals

Interventions: P-aminohippurate clearance study, Iohexol infusion, Hyperinsulinemic clamp

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07542964

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial participation Medical research Kidney function monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Pharmaceuticals

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