[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07187479":3,"trial-entities:NCT07187479":171,"trial-summary:NCT07187479":176},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":55,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":121,"locations":124,"central_contacts":157,"overall_officials":166,"references":169,"see_also_links":170},"NCT07187479","AZ-01","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","RECRUITING","2026-12","2026-08","2026-08-04","2025-10-14","Well Cell Global","INDUSTRY",false,"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).","The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)",[19,20,21],"Chronic Kidney Disease (Stages 4 and 5)","Kidney Disease","Type 2 Diabetes",[23,24,25,26],"chronic kidney disease","type 2 diabetes","diabetes","kidney disease","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},120,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"OTHER","Physiologic Insulin Resensitization (PIR)","PIR is a physician-directed treatment that uses an exterior infusion pump to deliver insulin intravenously.",[40],"Physiologic Insulin Resensitization (PIR) Group",[42,46,49,52],{"measure":43,"description":44,"timeFrame":45},"Estimated Glomular Filtration Rate (eGFR)","Assess the eGFR of patients in the PIR group as compared to the SOC group","12 and 24 weeks",{"measure":47,"description":48,"timeFrame":45},"Blood Urea Nitrogen\u002FCreatinine Ratio (BUN\u002FCr)","Assess the BUN\u002FCr of patients in the PIR group as compared to the SOC group",{"measure":50,"description":51,"timeFrame":45},"Cystatin C","Assess the Cystatin C of patients in the PIR group as compared to the SOC group",{"measure":53,"description":54,"timeFrame":45},"Urine albumin-creatinine ratio (ACR)","Assess the urine ACR of patients in the PIR group as compared to the SOC group",[56,59,62,65,68,71,74,77,80],{"measure":57,"description":58,"timeFrame":45},"Prescribed medication usage for control of symptoms","Assess changes of medications in the PIR group as compared to the SOC group",{"measure":60,"description":61,"timeFrame":45},"Hemoglobin A1c (HbA1c)","Assess the Hb1c of patients in the PIR group as compared to the SOC group",{"measure":63,"description":64,"timeFrame":45},"Fasting blood glucose","Assess the fasting blood glucose of patients in the PIR group as compared to the SOC group",{"measure":66,"description":67,"timeFrame":45},"Fasting insulin level","Assess the fasting insulin level of patients in the PIR group as compared to the SOC group",{"measure":69,"description":70,"timeFrame":45},"HOMA-IR","Assess the HOMA-IR of patients in the PIR group as compared to the SOC group",{"measure":72,"description":73,"timeFrame":45},"Blood Pressure","Assess the Blood Pressure of patients in the PIR group as compared to the SOC group",{"measure":75,"description":76,"timeFrame":45},"Lipid profile","Assess the Lipid Profile of patients in the PIR group as compared to the SOC group",{"measure":78,"description":79,"timeFrame":45},"C peptide","Assess the C peptide of patients in the PIR group as compared to the SOC group",{"measure":81,"description":82,"timeFrame":45},"EQ-5D-5L Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire)","Assess the Quality of Life of patients in the PIR group as compared to the SOC group. Lower health index scores reflect greater health deficits.","ALL","18 Years",null,{"inclusion":87,"exclusion":101,"raw_text":120},[88,89,90,91,92,93,94,95,96,97,98,99,100],"Is age 18 or older (male or female)","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.","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.","In the opinion of the Investigator, is able to do all of the following:","Provide valid informed consent.","Understand and comply with study procedures as presented in the consent process.","Has the capacity or support to attend all required visits.","If female, the subject must meet either of the following sets of conditions:","Age ≥50 years and post-menopausal for at least one (1) year","Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy","Is of childbearing potential and meets both of the following criteria:","Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.","Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment",[102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119],"Has in the past two (2) years received treatment for a malignancy.","Current pregnancy or intends to become pregnant during the study","Has in the past one (1) year used non-prescription opioids or psychoactive drugs.","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.","Has within the past one (1) month participated in a clinical study involving either of the following:","An investigational drug or procedure for any clinical indication","An investigation method for glucose control using approved agents","Is nursing or is planning to nurse during the study.","Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load.","Has at screening, one or more of the following abnormal lab results:","Hb \\\u003C8 g\u002FdL","WBC \\\u003C2,000\u002FµL","Platelets \\\u003C50,000\u002FµL","ALT, AST, or Alkaline Phosphatase \\>5x ULN","ALT or AST \\>2.5x ULN, and Total Bilirubin \\>2x ULN","Serum albumin \\\u003C3 g\u002FdL","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.","Is on active dialysis at time of screening","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",[122,123],"ADULT","OLDER_ADULT",[125,143],{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":130,"contacts":131,"geoPoint":140},"Arizona Kidney Disease and Hypertension Center","Phoenix","Arizona","85027","United States",[132,137],{"name":133,"role":134,"phone":135,"email":136},"Cynthia Carrizoza, MS, CCRP","CONTACT","602-997-0484","ccarrizoza@akdhc.com",{"name":138,"role":139},"Sungchun Lee, MD","PRINCIPAL_INVESTIGATOR",{"lat":141,"lon":142},33.44838,-112.07404,{"facility":144,"status":8,"city":145,"state":128,"zip":146,"country":130,"contacts":147,"geoPoint":154},"Innovative Diabetic Center","Scottsdale","85258",[148,152],{"name":149,"role":134,"phone":150,"email":151},"Austin Mill, ACNP-BC","480-493-0900","austin.mill@getinnovative.care",{"name":153,"role":139},"Nezar Dahdal, MD",{"lat":155,"lon":156},33.50921,-111.89903,[158,162],{"name":159,"role":134,"phone":160,"email":161},"Richard Marchase, PhD","205-612-4763","rmarchase@gmail.com",{"name":163,"role":134,"phone":164,"email":165},"Samantha Villaverde","904-806-8280","samantha@wellcellglobal.com",[167],{"name":138,"affiliation":168,"role":139},"Arizona Kidney Disease and Hypertension Centers",[],[],{"nct_id":4,"conditions":172,"biomarkers":175},[173,174],"Chronic Kidney Disease","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":177,"summary":178,"prompt_version":188},true,{"design":179,"status":180,"heading":181,"summary":182,"follow_up":183,"word_count":184,"commitments":185,"compensation":186,"drugs_mentioned":187},"This is an interventional study comparing Physiologic Insulin Resensitization (PIR) to standard care, with a planned enrollment of 120 participants.","completed","Physiologic Insulin Resensitization (PIR) for Chronic Kidney Disease and Type 2 Diabetes","This study is looking at a treatment called Physiologic Insulin Resensitization (PIR) for people with Chronic Kidney Disease (CKD) (stages 3b, 4, or 5) and Type 2 Diabetes Mellitus (T2DM). PIR is a treatment given by a doctor using an external pump to deliver insulin directly into your veins. The researchers want to see if PIR improves kidney function. They will measure things like your estimated Glomerular Filtration Rate (eGFR), Blood Urea Nitrogen\u002FCreatinine Ratio (BUN\u002FCr), and Cystatin C at 12 and 24 weeks. You can join if you are 18 or older and have had CKD and T2DM for at least 6 months. The study aims to enroll 120 participants, but its current status is unclear.","Participants will be followed for at least 24 weeks, with measurements taken at 12 and 24 weeks.",116,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]