[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541102":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":32,"responsibleParty":56,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with Fabry Disease and impaired kidney function",null,"Participants included in this group\n\n* 18 years of age or above\n* Fabry Disease as verified by genetic analysis prior to inclusion\n* Impaired kidney function according to the KDIGO classification (UACR ≥ 30 mg\u002Fg and eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m2 \\[≥ CKD G3a\u002FA2\\])",{"label":13,"type":10,"description":14,"interventionNames":10},"Patients with Fabry Disease and normal kidney function","Participants included in this group\n\n* 18 years of age or above\n* Fabry Disease as verified by genetic analysis prior to inclusion\n* Normal kidney function according to the KDIGO classification (UACR \\\u003C 30 mg\u002Fg and eGFR ≥ 60 will be included \\[≤ CKD G2\u002FA1\\])",{"label":16,"type":10,"description":17,"interventionNames":10},"Healthy controls","Participants included in this group\n\n* 18 years of age or above\n* Normal kidney function according to the KDIGO classification (UACR \\\u003C 30 mg\u002Fg and eGFR ≥ 60 will be included \\[≤ CKD G2\u002FA1\\])\n\nFurthermore, healthy controls are excluded\n\n* Suspected of Fabry Disease or verified by genetic analysis\n* Related to a patient with Fabry Disease\n* Have cancer with an expected influence on life expectancy\n* Known apoplexia cerebri, heart failure or established kidney disease\n* Recently initiated or have had recent changes in antihypertensive medication (within 3 months)",[19],{"name":20,"affiliation":5,"role":21},"Caroline M Kistorp, Professor","PRINCIPAL_INVESTIGATOR",[23,28],{"name":20,"role":24,"phone":25,"phoneExt":26,"email":27},"CONTACT","35 45 96 42","0045","caroline.michaela.kistorp@regionh.dk",{"name":29,"role":24,"phone":30,"phoneExt":26,"email":31},"Niels H Brandt-Jacobsen, MD, PhD","41 81 30 07","niels.hoeeg.brandt-jacobsen.01@regionh.dk",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":41,"coordinates":42},"Point",[43,44],12.56553,55.67594,{"lat":44,"lon":43},[47,50,53],{"name":48,"role":24,"phone":49,"phoneExt":10,"email":27},"Caroline M Kistorp, MD, Ph.D","004535459642",{"name":51,"role":24,"phone":52,"phoneExt":10,"email":31},"Niels H Brandt-Jacobsen, MD, Ph.D","004538632412",{"name":54,"role":55,"phone":10,"phoneExt":10,"email":10},"Niels H Brandt-Jacobsen, MD","SUB_INVESTIGATOR",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Caroline Michaela Kistorp","Professor",[61],{"name":62,"class":63},"Sanofi","INDUSTRY","100541102","fibrosis-inflammation-oxygenation-of-renal-tissue-in-fabry-disease-100541102",false,"NCT06325488","Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease","FORTIFY","Fabry patients:\n\nInclusion Criteria:\n\n* Male and female individuals (≥18 years of age)\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Any contraindication for magnetic resonance imaging according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup\u002Ftattoos that cannot be declared MR compatible.\n* Pregnancy\n\nControl group Inclusion criteria\n\n* Male and female individuals (≥18 years of age)\n* Able to give informed consent Exclusion criteria\n* A genetically-verified diagnosis of Fabry disease.\n* Family member to a patient with a genetically-verified diagnosis of Fabry disease\n* Cancer expected to influence life expectancy.\n* Known heart failure, previous apoplexia or previously established kidney disease.\n* Initiation or change of antihypertensive therapy within 3 months of enrolment\n* Renal impairment as depicted by the CKD-EPI classification (≥ CKD G2\u002FA1)\n* Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup\u002Ftattoos that cannot be declared MR compatible.\n* Pregnancy",true,"ALL","18 Years",{"count":75,"type":76},60,"ESTIMATED","OBSERVATIONAL","The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.\n\nThe study will achieve this by:\n\n1\\) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.\n\n2\\) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy.",[80,81],"Fabry Disease","Chronic Kidney Diseases",[83,84,85],"Oxygenation","Inflammation","Fibrosis","2025-04-04",{"date":88,"type":89},"2025-04-06","ACTUAL",{"date":91,"type":89},"2024-06-01",{"date":93,"type":76},"2026-06-01",{"name":58,"class":6},1]