Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-11 @ 8:57 AM
Study NCT ID:
NCT04404127
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2020-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The trial will be blinded with respect to Basiliximab induction allocation. The study will be blinded to subjects and site study investigators, with the following exceptions:\n\nA single pharmacist A single biostatistician Patients with receive either basiliximab or an intravenous piggyback (IVPB) with normal saline depending on their allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of biopsy proven acute rejection within first year following transplant', 'timeFrame': '1 year after transplant'}], 'secondaryOutcomes': [{'measure': 'Rate of graft survival at 1 year', 'timeFrame': '1 year after transplant'}, {'measure': 'Rate of decline in eGFR at 6 months and at 12 months', 'timeFrame': '1 year after transplant'}, {'measure': 'Rate of emergence of de novo donor specific antibodies (DSAs)', 'timeFrame': '1 year after transplant'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['basiliximab', 'Rejection', 'De no vo donor specific antibodies', 'Low immunological risk', 'Induction'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Background:\n\nInduction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated\n\nAims:\n\nTo compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)\n\nMethods:\n\nProspective, randomized, double blind, non-inferiority, controlled clinical trial\n\nExpected Outcomes:\n\n1. Primary outcomes:\n\n Biopsy proven acute rejection within first year following transplant\n2. Secondary outcomes:\n\n 1. Patient and graft survival at 1 year\n 2. Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months\n 3. Emergence of de novo donor specific antibodies (DSAs)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male or female ≥ 18 years\n\n * Living donor\n * Low immunological risk (defined as):\n\n 1. First (primary) transplant\n 2. ≤ 4 antigen mismatches (HLA matching scheme)\n 3. Negative HLA Ab screening\n\nExclusion Criteria:\n\n* • High immunological risk\n\n * HLA identical or zero mismatched transplants\n * Receiving cyclosporin as primary maintenance immunosuppressant\n * Human immunodeficiency virus (HIV) co-infection\n * Pregnant or nursing female\n * Has received an investigational medication within the past 30 days\n * Has a known contraindication to the administration of Basiliximab\n * Suspected or known to have a serious infection\n * Multi-organ transplant'}, 'identificationModule': {'nctId': 'NCT04404127', 'briefTitle': 'Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'King Faisal Specialist Hospital & Research Center'}, 'officialTitle': 'Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'RAC # 2191177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'No induction Arm', 'interventionNames': ['Other: Normal Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Induction with basiliximab', 'interventionNames': ['Drug: Basiliximab 20 milligram [Simulect]']}], 'interventions': [{'name': 'Basiliximab 20 milligram [Simulect]', 'type': 'DRUG', 'description': 'Basiliximab', 'armGroupLabels': ['Induction with basiliximab']}, {'name': 'Normal Saline', 'type': 'OTHER', 'description': 'No-Induction', 'armGroupLabels': ['No induction Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11211', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Aziza Ajlan, B.Sc. Pharm. BCPS', 'role': 'CONTACT', 'email': 'aajlan@kfshrc.edu.sa', 'phone': '966114647272', 'phoneExt': '80341'}, {'name': 'Aziza Ajlan, B.Sc. Pharm. BCPS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hassan Aleid', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tariq Ali', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hala Joharji', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Nazmi', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Khalid Almeshari', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Edward Devol', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dalal Alkortas,', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zinah Alabdulkarim', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaser Shah', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ibrahim Alahmadi', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Asad Ullah', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Aljedai', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'King Faisal Specialist Hospital and Research Centre (KFSHRC)', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Faisal Specialist Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Aziza A. Ajlan, B.Sc. Pharm. BCPS. Clinical pharmacy specialist- Solid Organ Transplant', 'investigatorFullName': 'Aziza Ajlan', 'investigatorAffiliation': 'King Faisal Specialist Hospital & Research Center'}}}}