[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641620":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":65,"collaborators":30,"id":68,"slug":30,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":30,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":97,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Dose Colchicine (LoDoCo)","ACTIVE_COMPARATOR","Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.",[13,14],"Drug: Low-dose Colchicine at 0.5mg daily","Other: Usual Care",{"label":16,"type":10,"description":17,"interventionNames":18},"Usual Care","Participants will receive usual care alone.",[14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Low-dose Colchicine at 0.5mg daily","Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.",[9],[26],"LoDoCo",{"type":6,"name":16,"description":28,"armGroupLabels":29,"otherNames":30},"Participants will receive usual care according to standard clinical practice and treating physician discretion.",[9,16],null,[32],{"name":33,"affiliation":34,"role":35},"Jing Chen, MD","University of Texas","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Alexandra R Hartman","CONTACT","614-420-1186","RESOLVE-CKD@UTSouthwestern.edu",{"name":43,"role":39,"phone":44,"phoneExt":30,"email":45},"Paola Lanza, MD","469-852-9550","paola.lanza@UTSouthwestern.edu",[47],{"facility":5,"status":30,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Dallas","Texas","75390","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-96.80667,32.78306,{"lat":57,"lon":56},[60,63,64],{"name":38,"role":39,"phone":61,"phoneExt":30,"email":62},"214-645-8294","alexandra.hartman@UTSouthwestern.edu",{"name":43,"role":39,"phone":44,"phoneExt":30,"email":45},{"name":33,"role":35,"phone":30,"phoneExt":30,"email":30},{"type":35,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jing Chen","Professor","100641620",false,"NCT07654231","Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD","Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)","RESOLVE-CKD","Inclusion Criteria:\n\n* Men and women aged 18-\\\u003C70 years of all race\u002Fethnicity groups\n* CKD stage 3 (estimated glomerular filtration rate (eGFR) \\>30 to 59 ml\u002Fmin\u002F1.73m2)\n* Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg\u002Fg\n* Cardiac artery calcification (CAC) Agatston score ≥30\n* Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Current Colchicine therapy\n* Hepatic disease\n* Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.\n* Immunosuppression\n* Current use of chemotherapy drugs or active cancer\n* Pregnancy\u002Fbreastfeeding\n* Hospitalized within the past 6 months\n* Allergic\u002Fintolerance to colchicine\n* Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir\u002Fritonavir, Saquinavir, Nelfinavir)\n* Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)\n* Human immunodeficiency virus (HIV) infection\n* Gout attack ≥ 1 time per year\n* Severe anemia (hemoglobin \\\u003C 8 g\u002Fdl for women and \\\u003C 9 g\u002Fdl for men)\n* eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n* uACR \\\u003C200 mg\u002Fg\n* White blood cell count (WBC) \\\u003C3.0 x109\u002FL\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x Upper Limit of Normal (ULN)\n* Total bilirubin \\>2 x ULN\n* Glucose \\>300mg\u002Fdl\n* Uses nicotine products or other recreational drugs\n* Unable to read or speak English\n* Participant in other conflict clinical trial,\n* Unable to complete the study measurements\n* Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans\n* Unsafe to participate in this study per investigator's judgement.","ALL","18 Years","69 Years",{"count":79,"type":80},60,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.\n\nSuccessful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.",[86,87,88,89,90,91],"Chronic Kidney Disease Mineral and Bone Disorder","Hypertension","Diabetes","Dyslipidemia","Atherosclerotic Cardiovascular Disease (ASCVD)","Chronic Kidney Disease (Stage 3)",[93,94,95,96],"Chronic Kidney Disease","CVD","vascular calcification","Colchicine","NOT_YET_RECRUITING","2026-06-17",{"date":100,"type":101},"2026-06-22","ACTUAL",{"date":103,"type":80},"2026-07-01",{"date":105,"type":80},"2027-12-31",{"name":5,"class":6},1]