[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582758":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Gødstrup Hospital","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Ketone diol (Ketone-IQ), then Placebo drink","For four weeks each subject will receive Ketone Diol, R-1,3-butanediol, administered as a drink (Ketone-IQ) twice a day, then crossed over to receive a taste and volume matched placebo drink for four weeks.\n\nEach individual will receive 400mg\u002Fkg before bedtime in addition to 200mg\u002Fkg with a minimum of 6 hours in between throughout the treatment period.",[12,13],"Dietary Supplement: Ketone Diol, R-1,3-butanediol (Ketone-IQ)","Other: Placebo drink",{"label":15,"type":6,"description":16,"interventionNames":17},"Placebo drink, then Ketone diol (Ketone-IQ)","For four weeks each subject will receive a placebo drink twice a day, then crossed over to receive Ketone Diol, R-1,3-butanediol, administered as a drink (Ketone-IQ) twice a day for four weeks.\n\nEach individual will receive 400mg\u002Fkg before bedtime in addition to 200mg\u002Fkg with a minimum of 6 hours in between throughout the treatment period.",[12,13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","Ketone Diol, R-1,3-butanediol (Ketone-IQ)","Effect variables will be measured on the last day of treatment with Ketone-IQ",[9,15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Placebo drink","Effect variables will be measured on the last day of treatment with Placebo",[9,15],[30],{"name":31,"affiliation":32,"role":33},"Trine Z Lyksholm, MD","University Clinic in Nephrology and Hypertenion, Godstrup Region Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","78432534","0045","trizur@rm.dk",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital","RECRUITING","Herning","Jutland","7400","Denmark","DK",{"type":50,"coordinates":51},"Point",[52,53],8.97662,56.13615,{"lat":53,"lon":52},[56],{"name":31,"role":36,"phone":57,"phoneExt":24,"email":39},"+4578432534",{"type":59,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100582758","effects-of-exogenous-ketosis-on-proteinuria-and-renal-function-100582758",false,"NCT06867471","Effects of Exogenous Ketosis on Proteinuria and Renal Function","Effects of Exogenous Ketosis on Proteinuria and Renal Function in Patients with Chronic Kidney Disease and Patients with Polycystic Kidney Disease","KETO-CKD","Inclusion Criteria\n\nStudy A (patients with CKD):\n\n* ACR \\> 200 mg\u002Fg \\\u003C3000 mg\u002Fg\n* eGFR \\>30 ml\u002Fmin\u002F1,73m2\n* Treatment with Renin-Angiotension System (RAS) blockers and SGLT-2 inhibitors for a minimum of 4 weeks prior to inclusion\n* Safe contraception if women in childbearing age\n\nStudy B (patients with PKD):\n\n* Prior diagnose with PKD\n* eGFR \\>30 ml\u002Fmin\u002F1,73m2\n* Treatment with Renin-Angiotension System (RAS) blockers for a minimum of 4 weeks prior to inclusion\n* Safe contraception if women in childbearing age\n\nExclusion Criteria (Study A+B)\n\n* Diabetes Mellitus type 1\n* Heart Failure\n* Liver Disease\n* Kidney transplant\n* Malignant diseases (except skin cancer)\n* Recent acute myocardial infarction (AMI), apoplexia\u002Ftransient ischemic attack (TIA) (within 3 months of inclusion)\n* Pregnancy or breast feeding\n* Alcohol or drug abuse\n* Periodic fasting within four weeks of inclusion\n* Routinely intake of ketogenic diet within four weeks of inclusion\n* Treatment with nitrate","ALL","18 Years",{"count":71,"type":72},43,"ESTIMATED","INTERVENTIONAL",[75],"NA","A randomized, placebo-controlled, double-blinded crossover study will be conducted. Fourteen patients with polycystic kidney disease (PKD) and 29 patients with proteinuric kidney disease will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.",[78,79,80,81],"Renal Insufficiency, Chronic","Polycystic Kidney Diseases","Proteinuria","Ketosis",[83,84,85,81,80,86],"Kidney physiology","Glomerular Filtration Rate","Chronic Kidney disease","Natriuresis","2025-03-06",{"date":89,"type":90},"2025-03-10","ACTUAL",{"date":92,"type":90},"2024-09-11",{"date":94,"type":72},"2025-12",{"name":5,"class":6},1]