[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100281766":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":80,"centralContacts":84,"locations":90,"responsibleParty":137,"collaborators":140,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":56,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":93,"whyStopped":56,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Emory University","OTHER",[8,16,22,27,32,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise training + 6R-BH4","EXPERIMENTAL","Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4.",[13,14,15],"Drug: 6R-BH4","Dietary Supplement: Folic acid","Other: Exercise training",{"label":17,"type":18,"description":19,"interventionNames":20},"Exercise training + 6R-BH4 placebo","ACTIVE_COMPARATOR","Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the study drug 6R-BH4.",[21,14,15],"Other: 6R-BH4 placebo",{"label":23,"type":18,"description":24,"interventionNames":25},"Stretching + 6R-BH4","Participants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4.",[13,14,26],"Other: Stretching",{"label":28,"type":29,"description":30,"interventionNames":31},"Stretching + placebo","PLACEBO_COMPARATOR","Participants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo instead of the active study drug.",[21,14,26],{"label":33,"type":18,"description":34,"interventionNames":35},"Exercise training + histidine and beta-alanine","Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take histidine and beta-alanine supplementation.",[15,36],"Dietary Supplement: Histidine and beta-alanine supplementation",{"label":38,"type":18,"description":39,"interventionNames":40},"Exercise training + histidine and beta-alanine placebo","Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the histidine and beta-alanine supplementation.",[15,41],"Other: Histidine and beta-alanine placebo",[43,52,57,62,66,72,76],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","6R-BH4","Participants will receive 200 mg of 6R-BH4 twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food.",[9,23],[49,50,51],"Tetrahydrobiopterin","Kuvan","Sapropterin dihydrochloride",{"type":6,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"6R-BH4 placebo","Participants will receive a placebo that is identical to 200 mg of 6R-BH4. The placebo will be taken twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food.",[17,28],null,{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":56},"DIETARY_SUPPLEMENT","Folic acid","Participants will take 1 mg of folic acid daily for 12 weeks. Folic acid is given because it enhances the binding affinity of BH4 to nitric oxide synthase (NOS), and also enhances the regeneration of BH4 from inactive BH2",[9,17,23,28],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":56},"Exercise training","Participants will exercise 3 times a week on a stationary ergometer. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) calculated utilizing the Karvonen method. Briefly, target exercise heart rate (HR) is calculated by subtracting the persons age from 220. Resting heart rate is then subtracted from this number. The answer is then multiplied by the target percent (50% for example) and the product is added back to resting heart rate to provide the target exercise session heart rate. Intensity will be increased by 5% every week (as tolerated by the participant) to a maximum of 80% of maximal heart rate. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week.",[9,17,33,38],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Stretching","Participants randomized to 'No Exercise Training' group will instead of aerobic exercise, undergo progressive whole body stretching and toning exercises designed for individuals 65 and older. This type of low intensity activity is designed not to increase heart rate and will serve as the Control group to the Exercise Training group. The Control group will come in for stretching sessions 3 times per week for 20-45 minutes.",[23,28],[71],"Control for exercise training",{"type":58,"name":73,"description":74,"armGroupLabels":75,"otherNames":56},"Histidine and beta-alanine supplementation","Histidine and beta-alanine are two over-the-counter supplements commonly used to enhance sports performance in athletes. Participants randomized to this study arm will receive combined histidine (4g\u002Fday) and beta-alanine (3.2g\u002Fday) supplementation.",[33],{"type":6,"name":77,"description":78,"armGroupLabels":79,"otherNames":56},"Histidine and beta-alanine placebo","Participants randomized to this study arm will receive a placebo to match combined histidine (4g\u002Fday) and beta-alanine (3.2g\u002Fday) supplementation.",[38],[81],{"name":82,"affiliation":5,"role":83},"Joe Nocera, PhD","PRINCIPAL_INVESTIGATOR",[85],{"name":86,"role":87,"phone":88,"phoneExt":56,"email":89},"Jeanie Park, MD","CONTACT","404-727-2525","jeanie.park@emory.edu",[91,111,120],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Emory University Hospital Midtown","RECRUITING","Atlanta","Georgia","30308","United States","US",{"type":100,"coordinates":101},"Point",[102,103],-84.38798,33.749,{"lat":103,"lon":102},[106,110],{"name":107,"role":87,"phone":108,"phoneExt":56,"email":109},"Dana DaCosta","404-727-7762","drdacos@emory.edu",{"name":86,"role":83,"phone":56,"phoneExt":56,"email":56},{"facility":112,"status":93,"city":94,"state":95,"zip":113,"country":97,"countryCode":98,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Emory University Hospital","30322",{"type":100,"coordinates":115},[102,103],{"lat":103,"lon":102},[118,119],{"name":107,"role":87,"phone":108,"phoneExt":56,"email":109},{"name":86,"role":83,"phone":56,"phoneExt":56,"email":56},{"facility":121,"status":93,"city":122,"state":95,"zip":123,"country":97,"countryCode":98,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Atlanta VA Health Care System","Decatur","30033",{"type":100,"coordinates":125},[126,127],-84.29631,33.77483,{"lat":127,"lon":126},[130,131,136],{"name":107,"role":87,"phone":108,"phoneExt":56,"email":109},{"name":132,"role":87,"phone":133,"phoneExt":134,"email":135},"Melanie Kankam","404-321-6111","7040","mljeffe@emory.edu",{"name":86,"role":83,"phone":56,"phoneExt":56,"email":56},{"type":83,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Jeanie Park","Associate Professor",[141],{"name":142,"class":143},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100281766","phase-2-neurovascular-transduction-during-exercise-in-chronic-kidney-disease-100281766",false,"NCT02947750","Neurovascular Transduction During Exercise in Chronic Kidney Disease","Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease","NeurovEx","Inclusion Criteria for Chronic Kidney Disease Patients:\n\n* Stage III or IV Chronic Kidney Disease, defined as reduction in estimated glomerular filtration rate (eGFR) to 15-59 cc\u002Fminute as calculated by the modified Modification of Diet in Renal Disease (MDRD) Study equation or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n* Stable renal function, with no greater than a 30% reduction in eGFR over the prior 3 months\n* Does not exercise regularly (defined as exercising less than 20 minutes twice per week)\n* Willing and able to cooperate with the study protocol\n\nInclusion Criteria for Control Study Participants:\n\n* Does not exercise regularly (defined as exercising less than 20 minutes twice per week)\n* Willing and able to cooperate with the study protocol\n\nExclusion Criteria:\n\n* severe CKD (eGFR\\\u003C15 cc\u002Fminute)\n* ongoing drug or alcohol abuse\n* diabetic neuropathy\n* any serious systemic disease that might influence survival\n* severe anemia with hgb level \\\u003C9 g\u002FdL\n* clinical evidence of congestive heart failure or ejection fraction below 35%\n* symptomatic heart disease determined by prior electrocardiogram, stress test, and\u002For history\n* treatment with central alpha agonists (clonidine)\n* uncontrolled hypertension with BP greater than 170\u002F100 mm Hg\n* low blood pressure with BP less than 100\u002F50\n* pregnancy or plans to become pregnant\n* current treatment with monoamine oxidase (MAO) inhibitors\n* inability to exercise on a stationary bicycle","ALL","18 Years","75 Years",{"count":156,"type":157},150,"ESTIMATED","INTERVENTIONAL",[160],"PHASE2","The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and\u002For treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.",[163],"Renal Insufficiency, Chronic",[165,166,167,168],"Hypertension","Kidney Disorder","Nephrology","Physiology","2026-05-14",{"date":171,"type":172},"2026-05-18","ACTUAL",{"date":174,"type":172},"2016-10",{"date":176,"type":157},"2027-04-30",{"name":5,"class":6},3]