[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640765":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":61,"collaborators":65,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":26,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":95,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":77},{"fullName":5,"class":6},"Kantonsspital Baden","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Treatment Periods","PLACEBO_COMPARATOR","The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial.\n\nStudy visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel.",[13],"Drug: Placebo Comparator (0.9% NaCl)",{"label":15,"type":16,"description":17,"interventionNames":18},"Anakinra Treatment Periods","EXPERIMENTAL","The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel.",[19],"Drug: Anakinra (interleukin-1 receptor antagonist)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Anakinra (interleukin-1 receptor antagonist)","Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). It is a clear, colourless-to-white solution, provided as a 150mg\u002FmL solution in pre-filled syringes, each containing of 100 mg of Anakinra in 0.67ml.\n\nOn the assigned study days, the patient will receive in a double-blind manner 100 mg of Anakinra intravenously through the hemodialysis circuit, administered 30 minutes before the end of the dialysis session.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Comparator (0.9% NaCl)","Placebo comparator will be 0.9% saline solution. A similar size and type of syringe will be used as for the Anakinra syringe making it difficult to distinguish which treatment of the two the patient is receiving.\n\nThe patient will receive 0.9% saline solution intravenously through the haemodialysis circuit 30 minutes before the end of the dialysis session, following the same administration procedure as Anakinra to maintain blinding.",[9],[32],{"name":33,"affiliation":34,"role":35},"Matthias Hepprich, PD Dr. med.","University of Basel, Claraspital Basel","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Marc Donath, Prof. Dr. Med","CONTACT","+41 56 486 25 52","marc.donath@umontreal.ca",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Kantonsspital Olten","Olten","Canton of Solothurn","4600","Switzerland","CH",{"type":51,"coordinates":52},"Point",[53,54],7.90329,47.34999,{"lat":54,"lon":53},[57,60],{"name":33,"role":39,"phone":58,"phoneExt":26,"email":59},"+41 61 685 89 40","endokrinologie@claraspital.ch",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Marc Donath","Prof. Dr. med Marc Y. Donath, Sponsor-Investigator",[66],{"name":5,"class":6},"100640765","phase-2-anakinra-for-the-treatment-of-postprandial-hypoglycemia-in-a-patient-with-total-gastrectomy-and-end-stage-renal-disease-100640765",false,"NCT07580079","Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease","Anakinra for the Treatment of Recurrent Postprandial Hypoglycemia After Total Gastrectomy in a Patient With End-Stage Renal Disease","AnPHy-ReD","This is an N-of-1 Trial, tailored-designed to a single participant.\n\n* total gastrectomy\n* severe episodes of postprandial hypoglycaemia after total gastrectomy","MALE",{"count":77,"type":78},1,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2","Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Right now, there is no approved medication for this condition-only a careful diet reduced in sugars and refined carbohydrates can sometimes help reduce symptoms.\n\nThe AnPHy-ReD study is a personalized research study, designed for just one patient. This patient is a 52-year-old man who has been struggling with severe post-meal low blood sugar ever since his stomach was removed due to tumor in 2017. He also has end-stage kidney disease and needs dialysis three times a week.\n\nThe study is being conducted at the Cantonal Hospital of Olten in Switzerland and lasts 10 weeks, including 24 study visits. Most of these visits will happen during the patient's regular dialysis sessions. For 6 weeks, the patient will take either the drug Anakinra or a placebo (a substance with no active ingredient), in a randomly chosen order. Neither the patient nor the doctors will know which one he is taking at any given time.\n\nDuring the study, the medical team will perform various tests, including physical check-ups and blood samples to look at sugar levels, various hormone levels and inflammation in the body. The patient will also wear a continuous glucose monitor (CGM) to track his blood sugar levels 24\u002F7. In addition, he will do several mixed meal tests-this means drinking a shake containing fats, proteins, and sugars during a study appointment to see in real time how his body processes food, with doctors measuring changes in blood sugar, hormone and inflammation markers over time. During the study duration any side effects or symptoms will be closely monitored.\n\nAt the end of the study, the team will compare the results between the times the patient took Anakinra and the times he took the placebo. This will help find out if Anakinra can reduce sharp drops in blood sugar after meals and improve his overall condition.",[84,85,86,87,88,89],"Postprandial Hypoglycemia","End-stage Renal Disease (ESRD)","Gastrectomy","Glucose Metabolism Disorders","Inflammation","Gastric Bypass Surgery",[84,91,92,93,94,88],"End-Stage Renal Disease","Anakinra","Gastric Bypass","IL-1 receptor antagonist","NOT_YET_RECRUITING","2026-05-05",{"date":98,"type":99},"2026-05-12","ACTUAL",{"date":101,"type":78},"2026-07",{"date":103,"type":78},"2026-12",{"name":63,"class":6}]