Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-23 @ 6:13 PM
Study NCT ID:
NCT03789006
Status:
UNKNOWN
Last Update Posted:
2019-01-03
First Post:
2018-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'D000077552', 'term': 'Basiliximab'}], 'ancestors': [{'id': 'D007106', 'term': 'Immune Sera'}, {'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': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2024-03-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2018-12-25', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute rejection', 'timeFrame': '6 months post kidney transplant', 'description': 'The incidence of acute rejection will include clinically diagnosed and biopsy proven acute rejection. Clinically diagnosed rejection includes at least 30% acute rise in serum creatinine level. Biopsy proven rejection will include both cellular and antibody mediated rejection according to Banff 2017 criteria'}, {'measure': 'One year graft survival', 'timeFrame': '1 year post kidney transplant', 'description': 'One year kidney allograft survival, uncensored for patient death'}], 'secondaryOutcomes': [{'measure': 'Cost of immunosuppressive medication', 'timeFrame': '1 year post kidney transplant+', 'description': 'Overall cost of immunosuppressive medication during first year post kidney transplant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant Rejection']}, 'descriptionModule': {'briefSummary': 'Kidney transplantation is the best available treatment option for patients with end stage renal disease. However, kidney transplantation requires life-long use of immunosuppressive medication. Because of the high cost of these medications we need to carefully evaluate the cost-effectiveness of each drug regimen, especially in low-middle income countries. The objective of this clinical trial is to compare the efficiency and cost of two immunosuppressive protocols after living donor kidney transplantation: (1) antithymocyte globulin, tacrolimus, azathioprine and prednisolone versus (2) basiliximab, tacrolimus, mycophenolate mofetil and prednisolone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult end-stage renal disease patients\n* First living donor kidney transplant.\n* Moderate immunological risk.\n\nExclusion Criteria:\n\n* Low immunological risk (HLA mismatches 000/100/010/110 with negative PRA).\n* High immunological risk (child to mother or husband to wife transplant, 2 DR mismatches).\n\n * Known hypersensitivity to any of the study medication.'}, 'identificationModule': {'nctId': 'NCT03789006', 'briefTitle': 'Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Khartoum'}, 'officialTitle': 'Efficiency of Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil When Used in Combination With Tacrolimus and Prednisolone in Living Donor Kidney Transplantation', 'orgStudyIdInfo': {'id': '033546'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ATG', 'description': 'Induction with antithymocyte immunoglobulin (Rabbit) (Grafalon) and maintenance with tacrolimus, azathioprine and prednisolone', 'interventionNames': ['Drug: Antithymocyte Immunoglobulin (Rabbit)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BAS', 'description': 'Induction with interleukin 2 receptor antagonist (basiliximab) and maintenance with tacrolimus, mycophenolate mofetil and prednisolone', 'interventionNames': ['Drug: Interleukin 2 Receptor Antagonist']}], 'interventions': [{'name': 'Antithymocyte Immunoglobulin (Rabbit)', 'type': 'DRUG', 'otherNames': ['grafalon'], 'description': 'Induction agent for living donor kidney transplantation', 'armGroupLabels': ['ATG']}, {'name': 'Interleukin 2 Receptor Antagonist', 'type': 'DRUG', 'otherNames': ['Basiliximab'], 'description': 'Induction agent for living donor kidney transplantation', 'armGroupLabels': ['BAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Khartoum', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Sarra Elamin, MD', 'role': 'CONTACT', 'email': 'sarraelamin@hotmail.com', 'phone': '(+249)912474666'}, {'name': 'Nazar Zulfo, MD', 'role': 'CONTACT', 'email': 'nazarzuflo@gmail.com', 'phone': '(+249)900948820'}], 'facility': 'Doctor Salma Center for Kidney Diseases', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}], 'centralContacts': [{'name': 'Sarra Elamin, MD', 'role': 'CONTACT', 'email': 'sarraelamin@hotmail.com', 'phone': '(+249)912474666'}, {'name': 'Nazar Zulfo, MD', 'role': 'CONTACT', 'email': 'nazarzuflo@gmail.com', 'phone': '(+249)900948820'}], 'overallOfficials': [{'name': 'Sarra Elamin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Nephrologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Khartoum', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Kidney Diseases and Surgery', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Physician and Nephrologist', 'investigatorFullName': 'Sarra Elamin', 'investigatorAffiliation': 'University of Khartoum'}}}}