Nctid:
NCT06233838
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D014511", "term"=>"Uremia"}], "ancestors"=>[{"id"=>"D007674", "term"=>"Kidney Diseases"}, {"id"=>"D014570", "term"=>"Urologic Diseases"}, {"id"=>"D052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M17261", "name"=>"Uremia", "asFound"=>"Uremia", "relevance"=>"HIGH"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "documentSection"=>{"largeDocumentModule"=>{"largeDocs"=>[{"date"=>"2023-03-14", "size"=>239914, "label"=>"Informed Consent Form", "hasIcf"=>true, "hasSap"=>false, "filename"=>"ICF_000.pdf", "typeAbbrev"=>"ICF", "uploadDate"=>"2024-01-22T21:54", "hasProtocol"=>false}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>394}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-02-28", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"the rate of change of IL-6, β2-MG and PTH i", "timeFrame"=>"in the 52nd week", "description"=>"the rate of change of IL-6, β2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["KHA80", "Maintenance hemodialysis", "IL-6", "β2-MG", "PTH"], "conditions"=>["Uremia", "Uremic Osteodystrophy", "Dialysis Related Complication"]}, "referencesModule"=>{"references"=>[{"pmid"=>"21534244", "type"=>"BACKGROUND", "citation"=>"Chen SJ, Jiang GR, Shan JP, Lu W, Huang HD, Ji G, Wu P, Wu GF, Wang W, Zhu C, Bian F. Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidney. Int J Artif Organs. 2011 Apr;34(4):339-47. doi: 10.5301/IJAO.2011.7748."}, {"pmid"=>"11423586", "type"=>"BACKGROUND", "citation"=>"Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-1557. doi: 10.1681/ASN.V1271549."}, {"pmid"=>"15685511", "type"=>"BACKGROUND", "citation"=>"Rao M, Guo D, Perianayagam MC, Tighiouart H, Jaber BL, Pereira BJ, Balakrishnan VS. Plasma interleukin-6 predicts cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2005 Feb;45(2):324-33. doi: 10.1053/j.ajkd.2004.09.018."}, {"pmid"=>"31856402", "type"=>"BACKGROUND", "citation"=>"Thang LV, Loc ND, Dung NH, Kien NT, Quyen DBQ, Tuan NM, Ha DM, Kien TQ, Dung NTT, Van DT, Van Duc N, Ha NTT, Toan PQ, Usui T, Nangaku M. Predicting 3-year mortality based on the tumor necrosis factor alpha concentration in low-flux hemodialysis patients. Ther Apher Dial. 2020 Oct;24(5):554-560. doi: 10.1111/1744-9987.13463. Epub 2020 Jan 27."}], "seeAlsoLinks"=>[{"url"=>"http://pubmed.ncbi.nlm.nih.gov/21534244/", "label"=>"Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidney"}, {"url"=>"http://pubmed.ncbi.nlm.nih.gov/11423586/", "label"=>"The microinflammatory state in uremia: causes and potential consequences."}, {"url"=>"http://pubmed.ncbi.nlm.nih.gov/15685511/", "label"=>"Plasma interlcukin-6 predicts cardiovascular mortality in hemodialysis patients"}, {"url"=>"http://pubmed.ncbi.nlm.nih.gov/31856402/", "label"=>"Predicting 3-year mortality based on thetumornecrosis factor alpha concentration in low-flux hemodialysis patients"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the decreasing rate of blood IL-6, β2-MG and PTH in maintenance hemodialysis patients in the 52nd week compared with routine hemodialysis.", "detailedDescription"=>"394 patients with maintenance hemodialysis were included in the study, and the blood purification time was ≥8 hours per week (including routine hemodialysis, high-throughput hemodialysis, hemodialysis filtration, hemoperfusion, etc.). Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week; The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. The follow-up data of 0, 4, 12, 24, 36 and 52 weeks of treatment in the two groups were collected, and the information of combined medication and adverse events was also collected."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥18 years old, regardless of sex;\n2. According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));\n3. receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;\n4. blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;\n5. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and perfusers;\n2. Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \\< 60× 109/L;\n3. Hemodialysis blood flow \\< 200 ml/min.\n4. Kt/V\\<1.2;\n5. Serum albumin \\< 30g/L;\n6. Parathyroid resection within one year;\n7. people with low blood pressure and severe cardiopulmonary insufficiency;\n8. lactating or pregnant women or those who plan to be pregnant within one year;\n9. infection, history of malignant tumor, active stage of rheumatic immune disease;\n10. Patients whose life expectancy is less than one year;\n11. Other clinical researchers are currently or recently (within 30 days);\n12. According to the researcher's judgment, the patient has other unsuitable conditions."}, "identificationModule"=>{"nctId"=>"NCT06233838", "briefTitle"=>"Multi-center Clinical Study on Hemoperfusion of KHA80", "organization"=>{"class"=>"OTHER", "fullName"=>"First Affiliated Hospital of Fujian Medical University"}, "officialTitle"=>"Prospective, Multicenter, Randomized, Open Label Study on the Efficacy and Safety of Comparison of KHA80 Blood Perfusion Combined With Hemodialysis and Conventional Hemodialysis in Clearing IL-6, β2-MG and PTH in Maintenance Hemodialysis Patients", "orgStudyIdInfo"=>{"id"=>"8339-001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"KHA80 hemoperfusion treatment", "description"=>"The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month.", "interventionNames"=>["Device: KHA80 hemoperfusion treatment"]}, {"type"=>"NO_INTERVENTION", "label"=>"Routine hemodialysis", "description"=>"Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week."}], "interventions"=>[{"name"=>"KHA80 hemoperfusion treatment", "type"=>"DEVICE", "description"=>"On the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month.", "armGroupLabels"=>["KHA80 hemoperfusion treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"350000", "city"=>"Fuzhou", "state"=>"Fujian", "country"=>"China", "contacts"=>[{"name"=>"Jianxin Wan, doctor", "role"=>"CONTACT", "email"=>"wanjx@fjmu.edu.cn", "phone"=>"13805052715"}, {"name"=>"Yi Chen, doctor", "role"=>"CONTACT", "email"=>"chinaalec@126.com", "phone"=>"13600827047"}], "facility"=>"The First Affiliated Hospital of Fujian Medical University", "geoPoint"=>{"lat"=>26.06139, "lon"=>119.30611}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"First Affiliated Hospital of Fujian Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Clinical Professor", "investigatorFullName"=>"wanjianxin", "investigatorAffiliation"=>"First Affiliated Hospital of Fujian Medical University"}}}}