[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633410":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":47,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":26,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":26,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Chittagong Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Difelikefalin Group","EXPERIMENTAL","Difelikefalin (0.5 mcg\u002Fkg) will be administered intravenously at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks in patients with CKD-associated pruritus.",[13],"Drug: Difelikefalin Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Normal Saline) Group","PLACEBO_COMPARATOR","Participants will receive intravenous normal saline at the end of each hemodialysis session, three times per week, for 6 weeks, administered in a volume equivalent to the difelikefalin dose",[19],"Drug: Normal Saline (0.9% NaCl)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Difelikefalin Injection","ntravenous difelikefalin (κ-opioid receptor agonist) administered at a dose of 0.5 mcg\u002Fkg at the end of each hemodialysis session, three times weekly,for a total duration of 6 wks in patients undergoing maintenance hemodialysis with moderate to severe CKD -associated pruritus",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Normal Saline (0.9% NaCl)","Intravenous normal saline will be administered at the end of each hemodialysis session, three times per week, for a total duration of 6 weeks, in a volume equivalent to the difelikefalin dose.",[15],[32],{"name":33,"affiliation":34,"role":35},"PROF. DR. MD NURUL HUDA, FCPS,MD","Head of the department of nephrology,Chittagong medical college ,Hospital","STUDY_CHAIR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"MD SHARIFUL ISLAM SARKER, MBBS","CONTACT","+8801521555223","+8801738647201","sobujshariful@gmail.com",{"name":44,"role":39,"phone":45,"phoneExt":26,"email":46},"DR ZAKWAN ULLAH, MBBS","+8801680560222","sharifulnephrology@gmail.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","DR.MD.SHARIFUL ISLAM SARKER","Resident","100633410","difelikefalin-for-itching-in-hemodialysis-patients-with-chronic-kidney-disease-100633410",false,"NCT07526324","Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease","Effect of Difelikefalin on CKD-Associated Pruritus in Patients on Maintenance Hemodialysis: A Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n* Diagnosed with chronic kidney disease (CKD) on maintenance hemodialysis Undergoing hemodialysis for at least 3 months\n* Presence of moderate-to-severe pruritus defined as Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥4\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Known case of Primary skin disesease associated with Itching.\n* Known case of liver disease.\n* Known case of iron defeciency anaemia ,hematological malignancy.\n* Known case of hypothyroidism \\& hyperthyroidism.\n* Known case of allergic reaction to Opiates .\n* Pregnancy.\n* Drug abuse, or substance dependence","ALL","18 Years",{"count":61,"type":62},106,"ESTIMATED","INTERVENTIONAL",[65],"NA","A randomized, placebo-controlled, double-blind trial will be conducted in the Department of Nephrology at Chittagong Medical College Hospital, Chattogram, Bangladesh, over a period of one and a half years. A total of 102 patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis will be enrolled in the study.\n\nPatients with moderate-to-severe pruritus, defined as a Worst Itching Intensity Numerical Rating Scale (WI-NRS) score ≥ 4, will be included. Eligible participants will be randomly assigned in a 1:1 ratio to receive either difelikefalin (0.5 mcg\u002Fkg) or placebo administered intravenously after each hemodialysis session for 6 weeks.\n\nThe primary outcome measure will be the change in WI-NRS score from baseline to week 6. Secondary outcomes will include changes in quality of life assessed using the Skindex-10 scale. Adverse events and safety parameters will also be monitored throughout the study period.\n\nThe primary analysis will be conducted using the intention-to-treat principle. A per-protocol analysis may also be performed as a secondary analysis. Statistical analysis will be carried out using SPSS version 27.",[68,69],"Itching Symptoms","CKD 5D, Hemodialysis","NOT_YET_RECRUITING","2026-04-10",{"date":73,"type":74},"2026-04-13","ACTUAL",{"date":76,"type":62},"2026-04-26",{"date":78,"type":62},"2027-01-30",{"name":5,"class":6}]