Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-04 @ 4:50 PM
Study NCT ID:
NCT03470961
Status:
UNKNOWN
Last Update Posted:
2018-03-20
First Post:
2018-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000961', 'term': 'Antilymphocyte Serum'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse event', 'timeFrame': 'up to 3 months post-transplantation', 'description': "Incidence of patient's death,graft loss,acute rejection"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Grafalon ATG SPK'], 'conditions': ['CKD (Chronic Kidney Disease) Stage 5T', 'Diabetes Mellitus', 'Simultaneous Pancreas Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '27855166', 'type': 'RESULT', 'citation': 'Burkhalter F, Schaub S, Bucher C, Gurke L, Bachmann A, Hopfer H, Dickenmann M, Steiger J, Binet I. A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study. PLoS One. 2016 Nov 17;11(11):e0165233. doi: 10.1371/journal.pone.0165233. eCollection 2016.'}, {'pmid': '15814548', 'type': 'RESULT', 'citation': 'Kuypers DR, Malaise J, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y; Euro-SPK Study Group. Secondary effects of immunosuppressive drugs after simultaneous pancreas-kidney transplantation. Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii33-9, ii62. doi: 10.1093/ndt/gfh1080.'}]}, 'descriptionModule': {'briefSummary': 'A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.', 'detailedDescription': 'Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.\n\nThe secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function), pancreas function and renal function'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. with end-stage,diabetic nephropathy(type1or 2)\n2. Patients scheduled to undergo SPK with compatible ABO blood type.\n3. Peak PRA \\<50%\n4. Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.\n5. Patient must have signed the Patient Informed Consent Form.\n6. Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.\n\nExclusion Criteria:\n\n1. Patient is pregnant or breastfeeding.\n2. Patient has a positive T-cell crossmatch on the most recent serum specimen.\n3. Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.\n4. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.\n5. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.\n6. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.\n7. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.\n8. Donor is older than 55 years of age\n9. patients with bacterial, viral or mycotic infections which are not under therapeutically control'}, 'identificationModule': {'nctId': 'NCT03470961', 'acronym': 'PAISPK', 'briefTitle': 'Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin First Central Hospital'}, 'officialTitle': 'Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients: Single-centre, Prospective, Observational Study', 'orgStudyIdInfo': {'id': '2018N017KY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-Tlymphocyte Globulins', 'description': 'intravenous，2mg/kg/d，for 5 days', 'interventionNames': ['Drug: Anti-Tlymphocyte Globulins']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anti-thymocyte Globulins', 'description': 'intravenous，1.5mg/kg/d，for 4 days', 'interventionNames': ['Drug: Anti-Thymocyte Globulins']}], 'interventions': [{'name': 'Anti-Tlymphocyte Globulins', 'type': 'DRUG', 'otherNames': ['Grafalon', 'ATG-F'], 'description': 'Induction therapy regimen in simultaneous pancreas kidney transplantation', 'armGroupLabels': ['Anti-Tlymphocyte Globulins']}, {'name': 'Anti-Thymocyte Globulins', 'type': 'DRUG', 'otherNames': ['ATG'], 'description': 'Induction therapy regimen in simultaneous pancreas kidney transplantation', 'armGroupLabels': ['Anti-thymocyte Globulins']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin First central hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Yingxin FU, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin First Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin First Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department', 'investigatorFullName': 'Yingxin FU.MD', 'investigatorAffiliation': 'Tianjin First Central Hospital'}}}}