Not Yet RecruitingNot Applicable

Transgender Analysis of Nephrological Studies Focused on Renal Metrics

Netherlands60 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with gender dysphoria according to DSM-V * Expected to start gender-affirming hormone treatment in the upcoming month Exclusion Criteria: * Current or prior use of gender-affirming hormone therapy * Participation in other studies * Concomitant use of medication (specifically: antihypertensive agents, products, antidepressants, antipsychotic agents) * Known kidney disease (eGFR \< 60 ml/min; UACR \> 2.5 mg/mmol) * Diabetes mellitus * A history of cardiovascular disease (myocardial infarction; cardiac surgery or revascularization, unstable angina, heart failure, transient ischemic attack, cerebrovascular disease, or a previously undiagnosed arrhythmia) * Known iodine-related allergies * Metal in the body (such as pacemaker, ICD, neurostimulator, cochlear implant, or other metal) * Pregnancy * Claustrophobia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in measured glomerular filtration rate (GFR)

Timeframe: Baseline, 12 months after start GAHT

Trial details

NCT IDNCT07542964

SponsorAmsterdam UMC, location VUmc

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-09

View on ClinicalTrials.gov More Kidney Disease trials