[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07693543":3,"trial-entities:NCT07693543":137,"trial-summary:NCT07693543":140},{"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":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":53,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":97,"locations":100,"central_contacts":116,"overall_officials":122,"references":125,"see_also_links":136},"NCT07693543","UCSD-NR-001","Nicotinamide Riboside Supplementation in Chronic Kidney Disease","Pilot Randomized Crossover Trial of Nicotinamide Riboside in Chronic Kidney Disease (NR-CKD Trial)","NOT_YET_RECRUITING","2028-09-30","2026-07","2026-07-15","2026-10-01","University of California, San Diego","OTHER",true,"This study is testing whether a dietary supplement called nicotinamide riboside, (NR), can be used in adults with moderate chronic kidney disease. NR is a form of vitamin B3 that may help support cellular energy metabolism.\n\nThe main goal of this study is to see whether it is feasible for people with chronic kidney disease to take NR daily, complete study visits, and follow the study procedures. The study will also explore whether NR chloride affects markers of mitochondrial health, small blood vessel function, and physical function.\n\nParticipants will be randomly assigned to one of two treatment orders. One group will take NR first and placebo second. The other group will take placebo first and NR second. Placebo looks like NR but does not contain active NR. Each treatment period lasts 12 weeks, with an approximately 2-week washout period between treatments. Neither participants nor the study team will know which treatment participants are taking during each period.\n\nStudy visits will include blood and urine collection, physical function testing, and noninvasive tests of small blood vessel function. The study will enroll up to 36 adults with moderate chronic kidney disease at the University of California, San Diego.","Chronic kidney disease is associated with impaired mitochondrial function, vascular dysfunction, reduced physical function, and increased risk of cardiovascular and functional decline. Nicotinamide riboside is a vitamin B3 derivative and NAD+ precursor that may support cellular energy metabolism and vascular health.\n\nThis pilot study will evaluate the feasibility of using nicotinamide riboside in adults with moderate chronic kidney disease. The study uses a randomized, double-blind, placebo-controlled crossover design so that each participant receives both nicotinamide riboside chloride and placebo during separate treatment periods.\n\nIn addition to feasibility measures, the study will collect exploratory data on mitochondrial, microvascular, and physical function outcomes. These data will help determine whether a larger clinical trial of nicotinamide riboside in chronic kidney disease is practical and scientifically justified.",[19],"Chronic Kidney Disease",[21,22,23,24,25],"Nicotinamide riboside","Chronic kidney disease","Microvascular function","Physical function","Cell-free mitochondrial DNA","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},30,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"DIETARY_SUPPLEMENT","Nicotinamide Riboside (NR)","Nicotinamide riboside will be administered orally at a target dose of 1000 mg\u002Fday for 12 weeks during the active treatment period.",[39],"NR Then Placebo",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Matched Placebo (Capsules)","Matched placebo will be administered orally for 12 weeks during the placebo treatment period. The placebo will be identical or substantially similar in appearance to the active nicotinamide riboside study product to maintain blinding.",[44],"Placebo Then NR",[46,50],{"measure":47,"description":48,"timeFrame":49},"Change in plasma cell-free mitochondrial DNA","Change in plasma cell-free mitochondrial DNA concentration, measured as mitochondrial DNA copies per mL of plasma using droplet digital PCR.","Baseline, Week 12, and Week 26",{"measure":51,"description":52,"timeFrame":49},"Change in urine cell-free mitochondrial DNA","Change in urine cell-free mitochondrial DNA concentration, measured using droplet digital PCR and reported as mitochondrial DNA copies normalized to urine osmolarity.",[54,57,60,63,66,69],{"measure":55,"description":56,"timeFrame":49},"Change in skin fingernail capillary density","Change in skin capillary density, measured as capillaries per mm2 using capillaroscopy.",{"measure":58,"description":59,"timeFrame":49},"Change in skin blood flow","Change in skin blood flow, measured in laser Doppler perfusion units using laser Doppler flowmetry.",{"measure":61,"description":62,"timeFrame":49},"Change in six-minute walk distance","Change in distance walked during the six-minute walk test, measured in meters.",{"measure":64,"description":65,"timeFrame":49},"Change in Handgrip Strength","Change in handgrip strength, measured in kilograms using handheld dynamometry.",{"measure":67,"description":68,"timeFrame":49},"Change in Timed Up and Go","Change in Timed Up and Go test performance, measured in seconds.",{"measure":70,"description":71,"timeFrame":49},"Change in 30-second sit-to-stand","Change in the number of chair stands completed during the 30-second sit-to-stand test, measured as repetitions completed in 30 seconds.","ALL","30 Years",null,false,{"inclusion":77,"exclusion":83,"raw_text":96},[78,79,80,81,82],"Moderate chronic kidney disease not treated with dialysis, defined as eGFR 30-59 mL\u002Fmin\u002F1.73 m2 using the CKD-EPI equation.","Urine albumin-to-creatinine ratio (uACR) \\\u003C300 mg\u002Fg.","Able to provide informed consent.","Able to walk unassisted from room to room, with usual assistive device allowed if approved by study safety assessment.","Willing and able to comply with study procedures, visits, and study product administration.",[84,85,86,87,88,89,90,91,92,93,94,95],"Pregnancy.","Expectation to start dialysis within 6 months.","Unable to walk unassisted from room to room.","Institutionalization or inability to consent.","End-stage liver disease with cirrhosis.","HIV.","Oxygen-dependent COPD.","Baseline systolic blood pressure \\>170 mmHg or diastolic blood pressure \\>100 mmHg.","Current participation in another interventional trial.","Use of immunosuppressive medications, including steroids or calcineurin inhibitors.","Malignancy requiring active treatment or currently under surveillance at the discretion of the investigator.","Hospitalization for myocardial infarction, unstable angina, cerebrovascular accident, or unstable cardiac chest pain within the prior 3 months.","Inclusion Criteria:\n\n* Moderate chronic kidney disease not treated with dialysis, defined as eGFR 30-59 mL\u002Fmin\u002F1.73 m2 using the CKD-EPI equation.\n* Urine albumin-to-creatinine ratio (uACR) \\\u003C300 mg\u002Fg.\n* Able to provide informed consent.\n* Able to walk unassisted from room to room, with usual assistive device allowed if approved by study safety assessment.\n* Willing and able to comply with study procedures, visits, and study product administration.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Expectation to start dialysis within 6 months.\n* Unable to walk unassisted from room to room.\n* Institutionalization or inability to consent.\n* End-stage liver disease with cirrhosis.\n* HIV.\n* Oxygen-dependent COPD.\n* Baseline systolic blood pressure \\>170 mmHg or diastolic blood pressure \\>100 mmHg.\n* Current participation in another interventional trial.\n* Use of immunosuppressive medications, including steroids or calcineurin inhibitors.\n* Malignancy requiring active treatment or currently under surveillance at the discretion of the investigator.\n* Hospitalization for myocardial infarction, unstable angina, cerebrovascular accident, or unstable cardiac chest pain within the prior 3 months.",[98,99],"ADULT","OLDER_ADULT",[101],{"facility":102,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":113},"Altman Clinical and Translation Research Institute","San Diego","California","92093","United States",[108],{"name":109,"role":110,"phone":111,"email":112},"Armin Ahmadi, PhD","CONTACT","(619) 543-6248","a3ahmadi@ucsd.edu",{"lat":114,"lon":115},32.71571,-117.16472,[117,119],{"name":109,"role":110,"phone":118,"email":112},"619-543-6248",{"name":120,"role":110,"email":121},"Rakesh Malhotra, MD, MPH","r3malhotra@health.ucsd.edu",[123],{"name":109,"affiliation":13,"role":124},"PRINCIPAL_INVESTIGATOR",[126,130,133],{"pmid":127,"type":128,"citation":129},"27721479","BACKGROUND","Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038\u002Fncomms12948.",{"pmid":131,"type":128,"citation":132},"29599478","Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038\u002Fs41467-018-03421-7.",{"pmid":134,"type":128,"citation":135},"31278280","Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038\u002Fs41598-019-46120-z.",[],{"nct_id":4,"conditions":138,"biomarkers":139},[19],[],{"nct_id":4,"found":15,"summary":141,"prompt_version":150},{"design":142,"status":143,"heading":6,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is a randomized, double-blind, placebo-controlled crossover study with 30 participants. This means participants are randomly assigned to receive either Nicotinamide Riboside or a placebo first, and neither you nor the study staff will know which you are taking at any given time.","completed","This study is looking at whether a dietary supplement called Nicotinamide Riboside (a form of vitamin B3) can be used safely and effectively by adults with moderate chronic kidney disease (CKD). You might be able to join if you are between 30 and 99 years old, have moderate CKD (eGFR 30-59 mL\u002Fmin\u002F1.73 m2), and your urine albumin-to-creatinine ratio (uACR) is less than 300 mg\u002Fg. The main goal is to see if it's practical for people with CKD to take Nicotinamide Riboside daily and complete study visits. Researchers will also explore if Nicotinamide Riboside affects markers of cell health and physical function. You will either take Nicotinamide Riboside first and then a matched placebo (an inactive capsule that looks the same), or vice versa.","Participants will be followed for at least 26 weeks, with measurements taken at Baseline, Week 12, and Week 26.",123,"You will take either Nicotinamide Riboside or a placebo orally for 12 weeks during each treatment period. Study visits will occur at Baseline, Week 12, and Week 26.","Not stated in the trial record.",[],"v2"]