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Transgender Analysis of Nephrological Studies Focused on Renal Metrics

NCT07542964 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2026-04-21

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

Hyperinsulinemic clamp

Glucose/insulin infusion to measure insulin sensitivity

DIAGNOSTIC_TEST

P-aminohippurate clearance study

To measure effective renal plasma flow (ERPF), small doses of a substance called p-aminohippurate will be used

DIAGNOSTIC_TEST

Iohexol infusion

To measure glomerular filtration rate (GFR) iohexol clearance will be performed

Sponsors & Collaborators

  • Dutch Kidney Foundation

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542964 on ClinicalTrials.gov