TransgenderismNCT04482920
Effect of Hormone Therapy on Renal Function
An observational study of Transgenderism and Kidney Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults. Read more about this study
- Who is it for?
- Ages 17 to 30 years
- Conditions the study is for
- Transgenderism, Kidney Diseases, Kidney Injury
- What is being tested?
- p-aminohippurate clearance study and Iohexol infusion
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- Child, Adult
Study population: 20 transgender youth and young adults (10 transgender females, 10 transgender males) before and 3 months after initiation of gender affirming hormone therapy to determine the impact of gender affirming hormone therapy on intrarenal hemodynamic function and tubular function.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Prior gender affirming hormone therapy use
- Prior gonadectomy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045'
About this study
Official title: The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth
The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.
- Conditions
- Transgenderism, Kidney Diseases, Kidney Injury
- Being tested
- p-aminohippurate clearance study, Iohexol infusion
- Medical subject headings
- Transsexualism, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p-aminohippurate clearance studyDiagnostic test
To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.
Iohexol infusionDiagnostic test
To measure glomerular filtration rate (GFR)
| Study group | Role | What they receive |
|---|---|---|
| Transgender males | Transgender males who are clinically ready to start testosterone Receives: Diagnostic Test: p-aminohippurate clearance study; Diagnostic Test: Iohexol infusion | |
| Transgender females | Transgender females who are clinically ready to start estradiol Receives: Diagnostic Test: p-aminohippurate clearance study; Diagnostic Test: Iohexol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measured glomerular filtration rate (GFR)
Measured: Baseline, 3 months
Secondary outcomes (6)
Change in effective renal plasma flow
Measured: Baseline, 3 months
Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40])
Measured: Baseline, 3 months
Change in fat mass
Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Measured: Baseline, 3 months
Change in fat-free mass
Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Measured: Baseline, 3 months
Change in intracellular fluid
Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Measured: Baseline, 3 months
Change in extracellular fluid
Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Apr 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TransgenderismStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie J Nokoff, MD, MSCS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482920
- Sponsor's protocol ID
- 20-0572
- Status last verified
- May 2024
- First submitted
- 26 Jun 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Eeghen SA, Suijk DLS, Pyle LL, Narongkiatikhun P, Choi YJ, Nokoff NJ, Bjornstad P, Heijer MD, van Raalte DH. Changes in uric acid metabolism and associated plasma proteomics during sex hormone therapy. J Clin Transl Endocrinol. 2026 Feb 27;44:100434. doi: 10.1016/j.jcte.2026.100434. eCollection 2026 May.
PubMed 41858565van Eeghen SA, Pyle L, Narongkiatikhun P, Choi YJ, Obeid W, Parikh CR, Vosters TG, van Valkengoed IG, Krebber MM, Touw DJ, den Heijer M, Bjornstad P, van Raalte DH, Nokoff NJ. Unveiling mechanisms underlying kidney function changes during sex hormone therapy. J Clin Invest. 2025 Mar 25;135(9):e190850. doi: 10.1172/JCI190850. eCollection 2025 May 1.
PubMed 40193283
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth
- ClinicalTrials.gov ID
- NCT04482920
- Acronym / sponsor ID
- 20-0572
- Conditions
- Transgenderism, Kidney Diseases, Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender males | – | Diagnostic Test: p-aminohippurate clearance study, Diagnostic Test: Iohexol infusionTransgender males who are clinically ready to start testosterone |
| Transgender females | – | Diagnostic Test: p-aminohippurate clearance study, Diagnostic Test: Iohexol infusionTransgender females who are clinically ready to start estradiol |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- 20 transgender youth and young adults (10 transgender females, 10 transgender males) before and 3 months after initiation of gender affirming hormone therapy to determine the impact of gender affirming hormone therapy on intrarenal hemodynamic function and tubular function.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p-aminohippurate clearance studyTo measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used. | Diagnostic test | Transgender females, Transgender males |
| Iohexol infusionTo measure glomerular filtration rate (GFR) | Diagnostic test | Transgender females, Transgender males |
Primary outcome
Change in measured glomerular filtration rate (GFR)
Time frame: Baseline, 3 months
6 secondary outcomes
Change in effective renal plasma flow
Time frame: Baseline, 3 months
Change in biomarkers of tubular injury and repair (Neutrophil gelatinase-associated lipocalin [NGAL], Kidney injury molecule-1 [KIM-1], Chitinase-3-like protein 1 [YKL-40])
Time frame: Baseline, 3 months
Change in fat mass
Time frame: Baseline, 3 months
Change in fat-free mass
Time frame: Baseline, 3 months
Change in intracellular fluid
Time frame: Baseline, 3 months
Change in extracellular fluid
Time frame: Baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41858565van Eeghen SA, Suijk DLS, Pyle LL, Narongkiatikhun P, Choi YJ, Nokoff NJ, Bjornstad P, Heijer MD, van Raalte DH. Changes in uric acid metabolism and associated plasma proteomics during sex hormone therapy. J Clin Transl Endocrinol. 2026 Feb 27;44:100434. doi: 10.1016/j.jcte.2026.100434. eCollection 2026 May.
- Derived from this study: PubMed 40193283van Eeghen SA, Pyle L, Narongkiatikhun P, Choi YJ, Obeid W, Parikh CR, Vosters TG, van Valkengoed IG, Krebber MM, Touw DJ, den Heijer M, Bjornstad P, van Raalte DH, Nokoff NJ. Unveiling mechanisms underlying kidney function changes during sex hormone therapy. J Clin Invest. 2025 Mar 25;135(9):e190850. doi: 10.1172/JCI190850. eCollection 2025 May 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie J Nokoff, MD, MSCS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgenderism and Kidney Diseases, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measured glomerular filtration rate (GFR) (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482920, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.