[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607355":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":61,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":18,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":18,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Well Cell Global","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Physiologic Insulin Resensitization (PIR) Group","EXPERIMENTAL","Subject to receive Physiologic Insulin Resensitization (PIR)",[13],"Other: Physiologic Insulin Resensitization (PIR)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care (SOC) Group","NO_INTERVENTION","Subjects will receive standard of care",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"OTHER","Physiologic Insulin Resensitization (PIR)","PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.",[9],[26],{"name":27,"affiliation":28,"role":29},"Sungchun Lee, MD","Arizona Kidney Disease and Hypertension Centers","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Richard Marchase, PhD","CONTACT","205-612-4763","rmarchase@gmail.com",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Samantha Villaverde","904-806-8280","samantha@wellcellglobal.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Arizona Kidney Disease and Hypertension Center","RECRUITING","Phoenix","Arizona","85027","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-112.07404,33.44838,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":18,"email":59},"Cynthia Carrizoza, MS, CCRP","602-997-0484","ccarrizoza@akdhc.com",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"type":62,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100607355","outcomes-of-physiologic-insulin-resensitization-pir-in-patients-with-chronic-kidney-disease-and-type-2-diabetes-mellitus-100607355",false,"NCT07187479","Outcomes of Physiologic Insulin Resensitization (PIR) in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus","Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Is age 18 or older (male or female)\n* Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and\u002For injectable medications including insulin and\u002For GLP-1 receptor agonists.\n* In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months.\n* In the opinion of the Investigator, is able to do all of the following:\n\n  * Provide valid informed consent.\n  * Understand and comply with study procedures as presented in the consent process.\n  * Has the capacity or support to attend all required visits.\n* If female, the subject must meet either of the following sets of conditions:\n\n  o Is of non-childbearing potential, defined as meeting either of the following criteria:\n* Age ≥50 years and post-menopausal for at least one (1) year\n* Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\n* Is of childbearing potential and meets both of the following criteria:\n\n  * Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.\n  * Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment\n\nExclusion Criteria:\n\n* Has in the past two (2) years received treatment for a malignancy.\n* Current pregnancy or intends to become pregnant during the study\n* Has in the past one (1) year used non-prescription opioids or psychoactive drugs.\n* Has in the past six (6) months had a hypoglycemic event requiring urgent care and\u002For administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor.\n* Has within the past one (1) month participated in a clinical study involving either of the following:\n\n  * An investigational drug or procedure for any clinical indication\n  * An investigation method for glucose control using approved agents\n* Is nursing or is planning to nurse during the study.\n* Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load.\n* Has at screening, one or more of the following abnormal lab results:\n\n  * Hb \\\u003C8 g\u002FdL\n  * WBC \\\u003C2,000\u002FµL\n  * Platelets \\\u003C50,000\u002FµL\n  * ALT, AST, or Alkaline Phosphatase \\>5x ULN\n  * ALT or AST \\>2.5x ULN, and Total Bilirubin \\>2x ULN\n  * Serum albumin \\\u003C3 g\u002FdL\n* Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and\u002For clinical dysfunction (whether or not related to known medical illness or drug \u002F alcohol use) that would affect the subject's safety and\u002For compliance.\n* Is on active dialysis at time of screening","ALL","18 Years",{"count":73,"type":74},120,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).",[80,81,82],"Chronic Kidney Disease (Stages 4 and 5)","Kidney Disease","Type 2 Diabetes",[84,85,86,87],"chronic kidney disease","type 2 diabetes","diabetes","kidney disease","2025-10-16",{"date":90,"type":91},"2025-10-20","ACTUAL",{"date":93,"type":91},"2025-10-14",{"date":95,"type":74},"2026-06",{"name":5,"class":6},1]