Nctid:
NCT06236295
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009362", "term"=>"Neoplasm Metastasis"}, {"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000051436", "term"=>"Renal Insufficiency, Chronic"}, {"id"=>"D000006961", "term"=>"Hyperparathyroidism"}, {"id"=>"D000006962", "term"=>"Hyperparathyroidism, Secondary"}], "ancestors"=>[{"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000051437", "term"=>"Renal Insufficiency"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000009385", "term"=>"Neoplastic Processes"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000010279", "term"=>"Parathyroid Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M10698", "name"=>"Kidney Diseases", "asFound"=>"Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M12307", "name"=>"Neoplasm Metastasis", "asFound"=>"Secondary", "relevance"=>"HIGH"}, {"id"=>"M10012", "name"=>"Hyperparathyroidism", "asFound"=>"Hyperparathyroidism", "relevance"=>"HIGH"}, {"id"=>"M10013", "name"=>"Hyperparathyroidism, Secondary", "asFound"=>"Secondary Hyperparathyroidism", "relevance"=>"HIGH"}, {"id"=>"M26717", "name"=>"Renal Insufficiency, Chronic", "asFound"=>"Chronic Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M26718", "name"=>"Renal Insufficiency", "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"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M12330", "name"=>"Neoplastic Processes", "relevance"=>"LOW"}, {"id"=>"M13192", "name"=>"Parathyroid Diseases", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>303}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-09", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-10", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence and severity of any adverse events that occurred during the clinical study", "timeFrame"=>"through study completion, an average of 1 year"}], "secondaryOutcomes"=>[{"measure"=>"Percent change from baseline in predialysis iPTH during the EAP", "timeFrame"=>"through study completion, an average of 1 year"}, {"measure"=>"Percent change from baseline in predialysis serum cCa during the EAP", "timeFrame"=>"through study completion, an average of 1 year"}, {"measure"=>"Percent change from baseline in predialysis serum phosphorus during the EAP", "timeFrame"=>"through study completion, an average of 1 year"}, {"measure"=>"Percent change from baseline in predialysis calcium-phosphorus product during the EAP", "timeFrame"=>"through study completion, an average of 1 year"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis"]}, "descriptionModule"=>{"briefSummary"=>"This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Subject is 18 years of age or older\n2. Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.\n3. Subject must be receiving regular hemodialysis for at least 12 weeks\n4. BMI ≥18 kg/m2 and ≤35 kg/m2\n5. iPTH≥ 300pg/ mL\n\nExclusion Criteria:\n\n1. Subject has received a a history of malignant tumor within 5 years prior to screening\n2. Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.\n3. Postdialysis systolic blood pressure\\>180 mmHg and/or diastolic blood pressure\\>110 mmHg\n4. Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients\n5. Subject has a history of drug use or excessive alcohol use within 6 months prior to screening\n6. Female subjects who were pregnant or lactating\n7. Other reasons for not participating as deemed by the investigator"}, "identificationModule"=>{"nctId"=>"NCT06236295", "briefTitle"=>"Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Shanghai Hengrui Pharmaceutical Co., Ltd."}, "officialTitle"=>"Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial", "orgStudyIdInfo"=>{"id"=>"SHR6508-202"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"SHR6508", "interventionNames"=>["Drug: SHR6508"]}], "interventions"=>[{"name"=>"SHR6508", "type"=>"DRUG", "description"=>"SHR6508 will be administered to all the eligible subjects", "armGroupLabels"=>["SHR6508"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100044", "city"=>"Beijing", "state"=>"Beijing", "country"=>"China", "facility"=>"Peking University People's Hospital", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai Hengrui Pharmaceutical Co., Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
