[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497609":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":40,"enrollmentInfo":83,"targetDuration":40,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":48,"whyStopped":40,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Product - MIB 626","ACTIVE_COMPARATOR","The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily.",[13],"Drug: Investigational Product - MIB 626",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The eligible participants will be assigned to receive either NMN or placebo using concealed block randomization in a 1:1 ratio, stratified by sex (male, female), age (60 to 75, \\>75 years) and trial site. The randomization list will be generated by the unblinded biostatistician using the software R (www.r-project.org), and deployed in a secure, centralized web-based application accessible to study staff following confirmation of a participant's eligibility.",[9],[26],"NMN",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.",[15],[31],"Placebo for NMN",[33],{"name":34,"affiliation":5,"role":35},"Shalender Bhasin, MD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","6175259150",null,"sbhasin@bwh.harvard.edu",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Nancy Latham, PhD","6179999195","nklatham@bwh.harvard.edu",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-71.05977,42.35843,{"lat":58,"lon":57},[61,63,65],{"name":62,"role":38,"phone":44,"phoneExt":40,"email":45},"Nancy K Latham, PhD",{"name":64,"role":35,"phone":40,"phoneExt":40,"email":40},"Shalender Bhasin, MB BS",{"name":43,"role":66,"phone":40,"phoneExt":40,"email":40},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Shalendar Bhasin, MD","Principal Investigator, Professor of Medicine, Harvard Medical School Director, Research Program in Men's Health: Aging and Metabolism Co-Director, BWH Center for Transgender Health Director, Boston Claude D. Pepper Older Americans Independence Center",[71],{"name":72,"class":6},"Boston Medical Center","100497609","phase-2-nad-augmentation-in-diabetes-kidney-disease-100497609",false,"NCT05759468","NAD Augmentation in Diabetes Kidney Disease","NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial","DKD","Inclusion Criteria:\n\n1. A man or a postmenopausal woman (complete cessation of menses for one or more years and \u002For FSH \\> 20 U\u002FL), 30 years or older\n2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:\n\n   1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.\n   2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.\n   3. HbA1c \\>6.4%; or 2 fasting glucose \\> 125 mg\u002FdL\n3. Has an average of two or more morning UACR equal to or above 100mg\u002Fg creatinine each of which must be equal to or greater than 60 mg \u002F g creatinine with at least one UACR value measured during the screening visit.\n\n   a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.\n4. If type 2 diabetic and UACR is \\> 300 mg\u002Fg creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.\n5. eGFR \\> 25 mL\u002F min \u002F 1.73 m2\n6. Hemoglobin A1c \\\u003C10%\n7. Able to speak English or Spanish or Haitian Creole\n8. Willing and able to provide written informed consent\n9. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.\n\nExclusion criteria:\n\n1. Fasting morning UACR \\> 5,000 mg\u002F g creatinine\n2. Other laboratory abnormalities:\n\n   1. Has AST or ALT \\> 3 times the upper limit of normal\n   2. eGFR \\\u003C 25 mL\u002F min \u002F 1.73 m2\n   3. Hematocrit \\\u003C 0.34 or \\> 0.50 L\u002FL\n3. A major adverse cardiovascular event in preceding 3 months\n4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter\n5. Current alcohol or substance use disorder or dependence (DSM 5 criteria).\n6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.\n7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.\n8. Has a history of anaphylaxis from vitamin B3 derivatives\n9. BMI \\> 42.5 kg\u002F m2\n10. If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.","ALL","30 Years",{"count":84,"type":85},156,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.",[91,92],"Type2diabetes","Diabetic Kidney Disease",[94,95,96],"diabetes","type 2 diabetes","kidney disease","2026-04-08",{"date":99,"type":100},"2026-04-13","ACTUAL",{"date":102,"type":100},"2023-04-13",{"date":104,"type":85},"2027-03-31",{"name":5,"class":6},1]