Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 3:39 AM
Study NCT ID:
NCT06087003
Status:
COMPLETED
Last Update Posted:
2023-10-17
First Post:
2023-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Induction Therapy in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}], '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': 'D007106', 'term': 'Immune Sera'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 958}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-15', 'studyFirstSubmitDate': '2023-10-08', 'studyFirstSubmitQcDate': '2023-10-15', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute rejection (AR)', 'timeFrame': 'From baseline, kidney transplantation to data collection completion (June 30, 2023)', 'description': 'The clinical diagnosis of AR is based on a significant increase in serum creatinine and the exclusion of other causes. The diagnosis of biopsy-confirmed AR is based on relevant histological changes.'}], 'secondaryOutcomes': [{'measure': 'Cytomegalovirus (CMV) viremia', 'timeFrame': 'From baseline, kidney transplantation to data collection completion (June 30, 2023)', 'description': 'The serum CMV is greater than 500 copies/ml'}, {'measure': 'Pneumonia', 'timeFrame': 'From baseline, kidney transplantation to data collection completion (June 30, 2023)', 'description': 'Any pneumonia that showed the presence of lesion and required hospitalization'}, {'measure': 'Renal graft survival', 'timeFrame': 'From baseline, kidney transplantation to data collection completion (June 30, 2023)', 'description': 'The estimated glomerular filtration rate (eGFR) of patient is \\>15 ml/min/1.73m2'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant Rejection', 'Pediatric Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '29880345', 'type': 'BACKGROUND', 'citation': 'Antunes H, Parada B, Tavares-da-Silva E, Carvalho J, Bastos C, Roseiro A, Nunes P, Figueiredo A. Pediatric Renal Transplantation: Evaluation of Long-Term Outcomes and Comparison to Adult Population. Transplant Proc. 2018 Jun;50(5):1264-1271. doi: 10.1016/j.transproceed.2018.02.089.'}, {'pmid': '23726592', 'type': 'BACKGROUND', 'citation': 'Martinez-Mier G, Enriquez-De Los Santos H, Mendez-Lopez MT, Avila-Pardo SF, Budar-Fernandez LF, Gonzalez-Velazquez F. Rejection is a strong graft survival predictor in live donor pediatric renal transplantation using cyclosporine, mycophenolate mofetil, and steroids: 5-year outcomes in a single Mexican center. Transplant Proc. 2013 May;45(4):1442-4. doi: 10.1016/j.transproceed.2013.02.044.'}, {'pmid': '27699934', 'type': 'BACKGROUND', 'citation': 'Crowson CN, Reed RD, Shelton BA, MacLennan PA, Locke JE. Lymphocyte-depleting induction therapy lowers the risk of acute rejection in African American pediatric kidney transplant recipients. Pediatr Transplant. 2017 Feb;21(1). doi: 10.1111/petr.12823. Epub 2016 Oct 3.'}, {'pmid': '33350558', 'type': 'BACKGROUND', 'citation': 'Barton KT, Halani K, Galbiati S, Dandamudi R, Hmiel SP, Dharnidharka VR; NAPRTCS investigators. Late first acute rejection in pediatric kidney transplantation: A North American Pediatric Renal Trials and Collaborative Studies special study. Pediatr Transplant. 2021 Aug;25(5):e13953. doi: 10.1111/petr.13953. Epub 2020 Dec 22.'}, {'pmid': '33314638', 'type': 'BACKGROUND', 'citation': 'Riad S, Jackson S, Chinnakotla S, Verghese P. Primary pediatric deceased-donor kidney transplant recipients outcomes by immunosuppression induction received in the United States. Pediatr Transplant. 2021 Aug;25(5):e13928. doi: 10.1111/petr.13928. Epub 2020 Dec 12.'}, {'pmid': '28832451', 'type': 'BACKGROUND', 'citation': 'Mincham CM, Wong G, Teixeira-Pinto A, Kennedy S, Alexander S, Larkins N, Lim WH. Induction Therapy, Rejection, and Graft Outcomes in Pediatric and Adolescent Kidney Transplant Recipients. Transplantation. 2017 Sep;101(9):2146-2151. doi: 10.1097/TP.0000000000001577.'}, {'pmid': '12660504', 'type': 'BACKGROUND', 'citation': 'Aw MM, Taylor RM, Verma A, Parke A, Baker AJ, Hadzic D, Muiesan P, Rela M, Heaton ND, Mieli-Vergani G, Dhawan A. Basiliximab (Simulect) for the treatment of steroid-resistant rejection in pediatric liver transpland recipients: a preliminary experience. Transplantation. 2003 Mar 27;75(6):796-9. doi: 10.1097/01.TP.0000054682.53834.EA.'}, {'pmid': '11750379', 'type': 'BACKGROUND', 'citation': 'Goh HK, Lye WC. Biopsy-proven resolution of steroid-resistant acute rejection with basiliximab therapy in a renal allograft recipient. Transplant Proc. 2001 Nov-Dec;33(7-8):3213-4. doi: 10.1016/s0041-1345(01)02368-5. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the efficacy of two most commonly used induction therapy for the prevention of acute rejection (AR) after renal transplantation in children. The main question it aims to answer is:\n\nIs basiliximab (anti-CD25 monoclonal antibody) induction therapy effective and safe in preventing AR after kidney transplantation in children compared with anti-thymoglobulin polyclonal antibodies induction therapy?\n\nThe transplant and follow-up data of participants will be retrospectively collected.\n\nResearchers will compare the rate of AR to see if basiliximab (anti-CD25 monoclonal antibody) induction therapy is a better option for certain pediatric kidney transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort will be selected from five centers with the highest number of pediatric kidney transplant cases in China, including Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Changhai Hospital Affiliated to Naval Medical University, the First Affiliated Hospital of Zhengzhou University, the First Affiliated Hospital of Zhejiang University and the First Affiliated Hospital of Sun Yat-sen University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving the kidney graft from a deceased donor\n* Basiliximab or rATG induction therapy was used in perioperative period\n\nExclusion Criteria:\n\n* Recipients with pre-transplant calculated panel reactive antibodies (cPRA) \\>10%\n* Recipients of combined liver, pancreas or heart transplantation\n* No induction or other induction therapy was used in perioperative period\n* Recieving the kidney graft from a living donor'}, 'identificationModule': {'nctId': 'NCT06087003', 'acronym': 'PINK', 'briefTitle': 'Pediatric Induction Therapy in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Induction Therapy of Thymoglobulin Versus Basiliximab in the Prevention of Acute Rejection After Pediatric Kidney Transplantation', 'orgStudyIdInfo': {'id': 'PINK study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basilliximab induction group', 'description': 'Basiliximab was administered intravenously 4 hours before kidney graft reperfusion and at day 4 after kidney transplantation. For pediatric patients weighing \\> 30kg, the dose of Basiliximab was 20mg, otherwise was 10mg.', 'interventionNames': ['Drug: Basiliximab Injection']}, {'label': 'rATG induction group', 'description': 'Rabbit antithymoglobulin (rATG) was administered intravenously during kidney transplantation (pre-reperfusion) and 1-2 days after transplantation. The dose was about 0.5-1 mg/kg per day.', 'interventionNames': ['Drug: rabbit ATG']}], 'interventions': [{'name': 'Basiliximab Injection', 'type': 'DRUG', 'otherNames': ['Simulect'], 'description': 'As an induction treatment for kidney transplantation', 'armGroupLabels': ['Basilliximab induction group']}, {'name': 'rabbit ATG', 'type': 'DRUG', 'otherNames': ['Thymoglobuline'], 'description': 'As an induction treatment for kidney transplantation', 'armGroupLabels': ['rATG induction group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-sen University.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Changhai Hospital affiliated to Naval Military Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Gang Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gang Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gang Chen', 'investigatorAffiliation': 'Tongji Hospital'}}}}