[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608397":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":10,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Early CKD Patients",null,"eGFR \\> or = to 90 ml\u002Fmin\u002F1.73m2",{"label":13,"type":10,"description":14,"interventionNames":10},"Mild CKD Patients","eGFR 60-89 ml\u002Fmin\u002F1.73m2",{"label":16,"type":10,"description":17,"interventionNames":10},"Moderate CKD Patients","eGFR 30-59 ml\u002Fmin\u002F1.73m2",{"label":19,"type":10,"description":10,"interventionNames":10},"Healthy Controls",[21],{"name":22,"affiliation":5,"role":23},"Katherine M Dell, MD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","216-444-6123","pedsresearch@ccf.org",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":28},"Research Coordinator","216-386-9360",[33,50],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-81.69541,41.4995,{"lat":45,"lon":44},[48,49],{"name":30,"role":26,"phone":31,"phoneExt":10,"email":28},{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"facility":51,"status":35,"city":52,"state":53,"zip":54,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":42,"coordinates":56},[57,58],-75.16362,39.95238,{"lat":58,"lon":57},[61,65,68],{"name":62,"role":26,"phone":63,"phoneExt":10,"email":64},"Erum Hartung, MD, MTR","215-590-2449","ARPKD_studies@chop.edu",{"name":66,"role":26,"phone":67,"phoneExt":10,"email":10},"Kathryn Howarth","267-425-5541",{"name":62,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":23,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Katherine Dell","Professor of Pediatrics",[73],{"name":74,"class":75},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100608397","imaging-assessments-of-arpkd-kidney-disease-progression-100608397",false,"NCT07201025","Imaging Assessments of ARPKD Kidney Disease Progression","IMAGE-ARPKD","Inclusion criteria:\n\nALL SUBJECTS\n\n* Ages \\>6 years old\n* Able to lay still for 30 minutes in an MRI scanner ARPKD Patients\n* Clinical and\u002For genetic diagnosis of ARPKD\n* eGFR (creatinine based) \\>30ml\u002Fmin\u002F1.732 performed within the last year Healthy Controls\n* Otherwise healthy with no known structural or functional kidney disease\n* No history of hypertension or documented high blood pressure within the last year\n\nExclusion criteria:\n\nALL SUBJECTS\n\n* Contraindications to MRI (e.g. metal implants)\n* Parental\u002Fpatient refusal to sign an informed consent\u002F assent form ARPKD Patients\n* Prior kidney or other solid organ transplant\n* eGFR \\\u003C30ml\u002Fmin\u002F1.732 Healthy Controls\n* Systemic diseases known to place patient at risk for kidney disease (e.g. diabetes mellitus)\n* Obesity (BMI \\>95th percentile for age for \\\u003C18 years old, or BMI\\>30 for adults)\n* History of prematurity (\\\u003C32 weeks gestational age)",true,"ALL","6 Years",{"count":87,"type":88},60,"ESTIMATED","OBSERVATIONAL","Autosomal Recessive Polycystic Kidney Disease (ARPKD) is a potentially lethal genetic disorder for which there are currently no disease specific treatments. Clinical trials have been limited by the absence of robust measures of disease progression. The overall goal of this 5 year NIH-funded prospective, observational multicenter study conducted at CC (primary site) and Children's Hospital of Philadelphia (CHOP) (collaborating site) is establish a set of rapid, quantitative, and reproducible novel kidney MRI measures applicable to standard clinical MRI scanners, which could serve as potential biomarkers to measure response to therapy in patients across the disease spectrum and all ages.\n\nThe investigators will recruit a total of 45 ARPKD patients and 15 healthy controls at the the two sites . All subjects will be \\> or = 6yrs old with no contraindications to undergoing MRI (non contrast). ARPKD subjects will be recruited into one of 3 cohorts based on their estimated glomerular filtration rate (eGFR): early CKD (eGFR\\> or =90ml\u002Fmin\u002F1.73m2), mild CKD (60-89ml\u002Fmin\u002F1.73m2) and moderate CKD (30-59ml\u002Fmin\u002F1.73m2). For ARPKD subjects, participation will last 3 years and consist of a baseline and 3 subsequent annual visits. Healthy controls will only have 1 study visit. Study visits for all participants will include collection of clinical and demographic data, clinical blood and urine tests (E.g. serum creatinine) and MRI imaging. ARPKD (but not healthy subjects) will also undergo a measured GFR test (iohexol clearance) to accurately assess their kidney function.",[92],"Autosomal Recessive Polycystic Kidney Disease",[94,95,96,97,98],"MRI","ARPKD","Pediatric","Ciliopathy","Biomarker","2025-11-18",{"date":101,"type":102},"2025-11-21","ACTUAL",{"date":104,"type":102},"2024-12-12",{"date":106,"type":88},"2029-02-28",{"name":5,"class":6},2]