[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644365":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-ADPKD CKD group",null,"Patients with severe chronic kidney disease (CKD stages G4-G5, not on dialysis) previously enrolled in the ADAPT clinical study (NCT04794517) conducted at the Clinical Research Center for Rare Diseases \"Aldo e Cele Daccò\", Istituto di Ricerche Farmacologiche Mario Negri IRCCS will be included.",[13],"Other: Laboratory measurements",{"label":15,"type":10,"description":16,"interventionNames":17},"ADPKD group","A subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) previously enrolled in the REORIENTED clinical study (NCT05646420), will be selected (only if they present the same CKD stage as the non-ADPKD CKD group).",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"Laboratory measurements","Reverse T3 will be measured using a dedicated ELISA assay. Total T3, total T4, free T3, free T4, and TSH will be measured using chemiluminescent immunoassays according to the standard operating procedures of the Laboratory of Clinical Chemistry",[15,9],[24],{"name":25,"affiliation":26,"role":27},"Giuseppe Remuzzi, M.D.","Istituto Di Ricerche Farmacologiche Mario Negri","STUDY_CHAIR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Matias Trillini, M.D.","CONTACT","+390354535411","matias.trillini@marionegri.it",[35],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Clinical Research Centre for Rare Diseases Aldo e Cele Daccò","Ranica","BG","24020","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],9.71335,45.72328,{"lat":46,"lon":45},{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644365","thyroid-hormones-in-ckd-100644365",false,"NCT07663773","Thyroid Hormones in CKD","Deciphering the Role of Thyroid Hormones in Severe Non-ADPKD Chronic Kidney Disease","THYROID-CKD","Inclusion criteria\n\n* Non-ADPKD CKD\n\n  * CKD stage G4, included in the ADAPT study\n  * Availability of stored serum and urine samples in the biobank suitable for thyroid hormone analysis\n  * Availability of relevant clinical and laboratory data within a predefined time window from sample collection\n  * Signed informed consent for storage and future research use of biological samples and clinical data\n* ADPKD CKD\n\n  * CKD stage G4, included in the REORIENTED study\n  * Availability of complete thyroid hormone profile and relevant clinical data\n\nExclusion criteria (applied to both groups as far as possible)\n\n* Known history of thyroid disease (hypothyroidism, hyperthyroidism, thyroiditis, or thyroid cancer)\n* Treatment with thyroid hormone replacement or antithyroid drugs\n* Use of medications known to interfere with thyroid function (e.g., amiodarone, lithium, interferon)\n* Systemic corticosteroid or immunosuppressive therapy at the time of sampling (if data available)\n* Dialysis treatment or history of kidney transplantation at the time of sampling\n* Acute illness, infection, or hospitalization close to the time of sample collection (if identifiable)","ALL","18 Years",{"count":61,"type":62},51,"ESTIMATED","OBSERVATIONAL","This is a retrospective, observational, study evaluating circulating thyroid hormone profiles in patients with severe chronic kidney disease (CKD stages G4-G5, non-dialysis). The study includes one cohort of patients with non-ADPKD CKD and a second including a matched subset of patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) at the same CKD stage,.\n\nFor the non-ADPKD CKD group, serum and urine samples will be retrieved from the certified biobank of the Centro Daccò (Mario Negri IRCCS). For the ADPKD group, analyses will be performed exclusively using existing clinical and laboratory data available within the REORIENTED study database.\n\nLaboratory measurements will be performed on stored biological samples from the non-ADPKD CKD group to assess thyroid hormones (rT3, fT3, tT3, fT4, tT4, and TSH). Clinical and laboratory data for both cohorts will be obtained from the respective study databases and linked within a predefined temporal window relative to sample collection (where applicable).",[66],"Chronic Kidney Disease (Stages 4 and 5)",[68,69],"Thyroid Hormones","CKD","NOT_YET_RECRUITING","2026-06-18",{"date":73,"type":74},"2026-06-23","ACTUAL",{"date":76,"type":62},"2026-09",{"date":78,"type":62},"2027-09",{"name":5,"class":6},1]