Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04872751
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Response of Haemodialysis Patients Post Covid-19 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 425}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-02', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level', 'timeFrame': 'up to one year', 'description': 'Study the antibody synthesis induced by vaccination, among end stage renal failure patients, and the change in its level at 1 month, at 6 months and at 1 year after complete vaccination.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)', 'timeFrame': 'one month', 'description': 'Study the antibody synthesis and the change in its level after 1st inoculation of the vaccine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Response Post Covid 19 Vaccination']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with end-stage renal failure (ESRF) receiving hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme\n* 18 years old and above\n* consented to join the study\n\nExclusion Criteria:\n\n* patient who refused to be vaccinated\n* patient who deemed unsuitable for Covid vaccination'}, 'identificationModule': {'nctId': 'NCT04872751', 'acronym': 'Covid-19', 'briefTitle': 'Immune Response of Haemodialysis Patients Post Covid-19 Vaccination', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Penang Hospital, Malaysia'}, 'officialTitle': 'The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'NMRR-21-634-59445'}}, 'contactsLocationsModule': {'locations': [{'zip': '10990', 'city': 'George Town', 'state': 'Pulau Pinang', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Ong Loke Meng, FRCS', 'role': 'CONTACT', 'email': 'onglokemeng@gmail.com', 'phone': '00 604 2225333', 'phoneExt': '5767'}], 'facility': 'Penang Hospital', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}], 'centralContacts': [{'name': 'XueFang Tan', 'role': 'CONTACT', 'email': 'xf821020@hotmail.com', 'phone': '6042225333', 'phoneExt': '5576'}], 'overallOfficials': [{'name': 'LokeMeng Ong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penang Hospital, Malaysia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Dr.Ong Loke Meng', 'investigatorAffiliation': 'Penang Hospital, Malaysia'}}}}