Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04482920
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2020-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Hormone Therapy on Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014189', 'term': 'Transsexualism'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in measured glomerular filtration rate (GFR)', 'timeFrame': 'Baseline, 3 months'}], 'secondaryOutcomes': [{'measure': 'Change in effective renal plasma flow', 'timeFrame': 'Baseline, 3 months'}, {'measure': '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])', 'timeFrame': 'Baseline, 3 months'}, {'measure': 'Change in fat mass', 'timeFrame': 'Baseline, 3 months', 'description': 'Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy'}, {'measure': 'Change in fat-free mass', 'timeFrame': 'Baseline, 3 months', 'description': 'Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy'}, {'measure': 'Change in intracellular fluid', 'timeFrame': 'Baseline, 3 months', 'description': 'Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy'}, {'measure': 'Change in extracellular fluid', 'timeFrame': 'Baseline, 3 months', 'description': 'Quantified noninvasively by ImpediMed SFB7 single channel, tetra polar bioimpedance spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgenderism', 'Kidney Diseases', 'Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '40193283', 'type': 'DERIVED', 'citation': 'van 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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the effects of testosterone or estradiol on kidney function in transgender adolescents and young adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as transgender\n* Age 17-30 years (inclusive)\n* Plan to start gender affirming hormone therapy (testosterone or estradiol) clinically in ≤ 1 months and remain on for at least 3 months\n\nExclusion Criteria:\n\n* Cognitive, psychiatric or physical impairment resulting in inability to tolerate the study procedures (e.g. intellectual disability, schizophrenia, hallucinations)\n* Type 1 or Type 2 diabetes\n* Chronic kidney disease, or eGFR \\<60ml/min/1.73m2 by CKD-EPI formulation\n* Uncontrolled hypertension (resting BP ≥ 140/90 mm/Hg)\n* Allergy to shellfish, iodine or iohexol\n* Currently taking: sulfonamides, procaine, thiazolesulfone and probenecid (renal clearance measurements of PAH cannot be made accurately if individuals are on these medications)\n* Prior gender affirming hormone therapy use\n* Prior gonadectomy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04482920', 'briefTitle': 'Effect of Hormone Therapy on Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'The Effects of Hormone Therapy on Renal Hemodynamic Function in Transgender Youth', 'orgStudyIdInfo': {'id': '20-0572'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transgender males', 'description': 'Transgender males who are clinically ready to start testosterone', 'interventionNames': ['Diagnostic Test: p-aminohippurate clearance study', 'Diagnostic Test: Iohexol infusion']}, {'label': 'Transgender females', 'description': 'Transgender females who are clinically ready to start estradiol', 'interventionNames': ['Diagnostic Test: p-aminohippurate clearance study', 'Diagnostic Test: Iohexol infusion']}], 'interventions': [{'name': 'p-aminohippurate clearance study', 'type': 'DIAGNOSTIC_TEST', 'description': 'To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.', 'armGroupLabels': ['Transgender females', 'Transgender males']}, {'name': 'Iohexol infusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'To measure glomerular filtration rate (GFR)', 'armGroupLabels': ['Transgender females', 'Transgender males']}]}, 'contactsLocationsModule': {'locations': [{'zip': "80045'", 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Natalie J Nokoff, MD, MSCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}