Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT03857568
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR0410 Injection in Hemodialysis Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse events in terms of changes in Hematology', 'timeFrame': '14 days', 'description': 'Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count'}, {'measure': 'Incidence of Adverse events in terms of changes in Urinalysis', 'timeFrame': '14 days', 'description': 'Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites'}, {'measure': 'Incidence of Adverse events in terms of changes in Biochemistry', 'timeFrame': '14 days', 'description': 'Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol'}, {'measure': 'Incidence of Adverse events in terms of changes in 12-lead ECGs', 'timeFrame': '14 days', 'description': 'The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Up to 24 hours post dose', 'description': 'Plasma SHR0410 Area Under the Concentration-time Curve (AUC)'}, {'measure': 'Time to the peak plasma concentration (Tmax)', 'timeFrame': 'Up to 24 hours post dose', 'description': 'Time to Maximum Plasma SHR0410 Concentration'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'Up to 24 hours post dose', 'description': 'Peak Plasma SHR0410 Concentration'}, {'measure': 'Half-time (T1/2)', 'timeFrame': 'Up to 24 hours post dose', 'description': 'Half-time of SHR0410'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pruritus']}, 'descriptionModule': {'briefSummary': 'This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis.', 'detailedDescription': 'This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis. Twenty-four eligible participants will be enrolled into 3 dose cohorts. SHR0410 will be administered after dialysis session. Safety assessments, PK assessments and efficacy evaluations will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to understand the study procedures, the risks involved and obtain written informed consent before any study related activity.\n* Male or female between the ages of 18 and 75 years, inclusive.\n* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, throughout the study period and for 28 days following last study drug dosing. Female subjects must be post-menopausal for at least 1 year, permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use a highly effective method of contraception throughout the study period and for 28 days following last study drug dosing.\n* Negative drug screen (including alcohol, amphetamines, cocaine, marijuana, opiates, phencyclidine, barbiturates, benzodiazepines, methadone, methamphetamines, tramadol, and tricyclic antidepressants) at screening and on admission to study site.\n\nExclusion Criteria:\n\n* Anticipated to receive a kidney transplant during the study.\n* Known history of allergic reaction to opiates such as hives (Note: side effects related to the use of opioids such as constipation or nausea would not exclude the participants from the study).\n* Within 12 months prior to screening, known or suspected history of drug abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).'}, 'identificationModule': {'nctId': 'NCT03857568', 'briefTitle': 'A Trial of SHR0410 Injection in Hemodialysis Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atridia Pty Ltd.'}, 'officialTitle': 'A Phase I, Randomized, Double-blind, Placebo-controlled Study of Intravenous SHR0410 to Evaluate Safety and Pharmacokinetics in Hemodialysis Participants.', 'orgStudyIdInfo': {'id': 'SHR0410-102-AU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR0410 group', 'description': 'SHR0410 will be dosed', 'interventionNames': ['Drug: SHR0410']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo will be dosed', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR0410', 'type': 'DRUG', 'description': 'drug will be dosed repeatedly', 'armGroupLabels': ['SHR0410 group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be dosed repeatedly', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia(WA)', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'overallOfficials': [{'name': 'Neil Boudville, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linear Clinical Research Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atridia Pty Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}