[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04430426":3,"trial-entities:NCT04430426":72,"trial-summary:NCT04430426":77},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":13,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":43,"std_ages":53,"locations":56,"central_contacts":65,"overall_officials":66,"references":70,"see_also_links":71},"NCT04430426","IRB-300005327","Heterozygous Individuals for AGXT and Kidney Stones","ENROLLING_BY_INVITATION","2032-08-01","2026-07","2026-07-20","2027-07-01","University of Alabama at Birmingham","OTHER",false,"This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies.",null,[18,19],"Kidney Stone","Urolithiasis, Calcium Oxalate",[21,22],"kidney stone","oxalate","INTERVENTIONAL",[25],"NA",{"count":27,"type":28},4,"ESTIMATED",[30],{"type":13,"name":31,"description":32,"armGroupLabels":33},"Controlled Diet","Participants will consume a controlled low oxalate diet for five days.",[34],"Controlled Dietary Study",[36],{"measure":37,"description":38,"timeFrame":39},"Urinary Oxalate Excretion","Urinary oxalate excretion from urine samples will be measured as mg\u002Fday","Baseline through Day 4",[],"ALL","18 Years",{"inclusion":44,"exclusion":49,"raw_text":52},[45,46,47,48],"at least 18 years of age","history of calcium oxalate stones","heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel","willingness to comply with a controlled diet for five days",[50,51],"pregnant individuals","individuals who are currently breast feeding","Inclusion Criteria:\n\n* at least 18 years of age\n* history of calcium oxalate stones\n* heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel\n* willingness to comply with a controlled diet for five days\n\nExclusion Criteria:\n\n* pregnant individuals\n* individuals who are currently breast feeding",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":12,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"Birmingham","Alabama","35233","United States",{"lat":63,"lon":64},33.52066,-86.80249,[],[67],{"name":68,"affiliation":12,"role":69},"Kyle Wood, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":73,"biomarkers":75},[74],"Nephrolithiasis",[76],"AGXT Gene",{"nct_id":4,"found":78,"summary":79,"prompt_version":89},true,{"design":80,"status":81,"heading":82,"summary":83,"follow_up":84,"word_count":85,"commitments":86,"compensation":87,"drugs_mentioned":88},"This is an interventional study with a planned enrollment of 4 participants. It is not specified if it is randomized or blinded.","completed","Study on AGXT Gene and Kidney Stones","This study is looking at how a specific gene change (a heterozygous mutation of the AGXT gene) affects how much oxalate (a substance that can form kidney stones) your body makes, especially if you've had calcium oxalate kidney stones before. You would eat a controlled low oxalate diet for five days. Researchers will measure the amount of oxalate in your urine to see if this gene change affects it. To join, you need to be at least 18 years old, have a history of calcium oxalate kidney stones, and have the specific AGXT gene mutation confirmed by an Invitae Nephrolithiasis Panel test. Pregnant or breastfeeding individuals cannot participate. The study is currently unclear on its recruitment status.","Urinary oxalate excretion will be measured from baseline through Day 4. It is not specified if there is follow-up after this period.",117,"You would need to follow a controlled low oxalate diet for five days and provide blood and urine samples.","Not stated in the trial record.",[],"v2"]