Transgender Analysis of Nephrological Studies Focused on Renal Metrics

NCT07542964 | Not Yet Recruiting

• 1 other identifier: NL-011071
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Kidney Disease; Kidney Injury; Transgender Individuals

Keywords

Transgender individuals; Kidney disease; Kidney injury; Gender affirming hormone treatment; Sex hormones

Outcome Measures

Primary Outcomes (1)

• Change in measured glomerular filtration rate (GFR)

  Baseline, 12 months after start GAHT

Secondary Outcomes (8)

• Change in effective renal plasma flow (ERPF)

  Baseline, 12 months after start GAHT

• Change in systemic hemodynamic function

  Baseline, 12 months after start GAHT

• Change in insulin sensitivity

  Baseline, 12 months after start GAHT

• Change in markers of tubular physiology

  Baseline, 12 months after start GAHT

• Changes in multiparametric kidney MRI

  Baseline, 12 months after start GAHT

Study Arms (2)

Transgender males

Individuals clinically scheduled to start GAHT with testosterone therapy

Diagnostic Test: P-aminohippurate clearance study; Diagnostic Test: Iohexol infusion; Diagnostic Test: Hyperinsulinemic clamp

Transgender women

Individuals clinically scheduled to start GAHT with estradiol and anti-androgen therapy

Diagnostic Test: P-aminohippurate clearance study; Diagnostic Test: Iohexol infusion; Diagnostic Test: Hyperinsulinemic clamp

Interventions

P-aminohippurate clearance study DIAGNOSTIC_TEST

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

Transgender males; Transgender women

Iohexol infusion DIAGNOSTIC_TEST

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

Transgender males; Transgender women

Hyperinsulinemic clamp DIAGNOSTIC_TEST

Glucose/insulin infusion to measure insulin sensitivity

Transgender males; Transgender women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The source population consists of adult patients with gender dysphoria, who are scheduled to start with GAHT in the Amsterdam University Medical Centre (AUMC) in Amsterdam. A total of 60 transgender individuals (30 transgender women, 30 transgender men) will be selected from this outpatient clinic.

You may qualify if:

• Diagnosed with gender dysphoria according to DSM-V
• Expected to start gender-affirming hormone treatment in the upcoming month

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dutch Kidney Foundation: collaborator

Study Sites (1)

Amsterdam UMC, location VU medical centre, internal medicine

Amsterdam, North Holland, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine samples

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

NL (1)