Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT04292418
Status:
UNKNOWN
Last Update Posted:
2020-03-03
First Post:
2020-02-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors of Rejection in Pediatric Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-29', 'studyFirstSubmitDate': '2020-02-29', 'studyFirstSubmitQcDate': '2020-02-29', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predictors of rejection', 'timeFrame': '2 year', 'description': 'detect the potentially predictors of rejection in pediatric kidney transplant recipient'}], 'secondaryOutcomes': [{'measure': 'measure corrected tacrolimus level and mycophenolic acid', 'timeFrame': '2 year', 'description': 'detect the role of corrected tacrolimus level in dose adjustment for better control of immunosuppressive therapy detect the role of neutrophil to lymphocytic ratio in prediction of kidney rejection Role of mycophenolic acid monitoring in prevention of rejection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rejection Acute Renal']}, 'referencesModule': {'references': [{'pmid': '31400969', 'type': 'RESULT', 'citation': 'Bulut IK, Taner S, Keskinoglu A, Sezer TO, Kabasakal C. Pediatric Kidney Transplantation in Patients With Urologic Anomalies. Transplant Proc. 2019 Sep;51(7):2257-2261. doi: 10.1016/j.transproceed.2019.01.155. Epub 2019 Aug 7.'}, {'pmid': '31383541', 'type': 'RESULT', 'citation': 'Tamain M, Sayegh J, Lionet A, Grimbert P, Philipponnet C, Hazzan M, Augusto JF, Buchler M, Merlin E, Kosmadakis G, Tiple A, Pereira B, Garrouste C, Heng AE. Extracorporeal photopheresis for the treatment of graft rejection in 33 adult kidney transplant recipients. Transfus Apher Sci. 2019 Aug;58(4):515-524. doi: 10.1016/j.transci.2019.06.031. Epub 2019 Jul 22.'}, {'pmid': '31477420', 'type': 'RESULT', 'citation': 'Park WY, Paek JH, Jin K, Park SB, Han S. Long-term Clinical Significance of Tacrolimus Trough Level at the Early Period After Kidney Transplantation. Transplant Proc. 2019 Oct;51(8):2643-2647. doi: 10.1016/j.transproceed.2019.03.065. Epub 2019 Aug 30.'}, {'pmid': '15885236', 'type': 'RESULT', 'citation': 'Akbas SH, Ozdem S, Caglar S, Tuncer M, Gurkan A, Yucetin L, Senol Y, Demirbas A, Gultekin M, Ersoy FF, Akaydin M. Effects of some hematological parameters on whole blood tacrolimus concentration measured by two immunoassay-based analytical methods. Clin Biochem. 2005 Jun;38(6):552-7. doi: 10.1016/j.clinbiochem.2005.02.011.'}, {'pmid': '26385862', 'type': 'RESULT', 'citation': 'Krischock LA, van Stralen KJ, Verrina E, Tizard EJ, Bonthuis M, Reusz G, Hussain FK, Jankauskiene A, Novljan G, Spasojevic-Dimitrijeva B, Podracka L, Zaller V, Jager KJ, Schaefer F; ESPN/ERA-EDTA Registry. Anemia in children following renal transplantation-results from the ESPN/ERA-EDTA Registry. Pediatr Nephrol. 2016 Feb;31(2):325-33. doi: 10.1007/s00467-015-3201-8. Epub 2015 Sep 18.'}, {'pmid': '28254584', 'type': 'RESULT', 'citation': 'Chinnakotla S, Verghese P, Chavers B, Rheault MN, Kirchner V, Dunn T, Kashtan C, Nevins T, Mauer M, Pruett T; MNUM Pediatric Transplant Program. Outcomes and Risk Factors for Graft Loss: Lessons Learned from 1,056 Pediatric Kidney Transplants at the University of Minnesota. J Am Coll Surg. 2017 Apr;224(4):473-486. doi: 10.1016/j.jamcollsurg.2016.12.027. Epub 2017 Feb 27.'}, {'pmid': '30374607', 'type': 'RESULT', 'citation': 'Schijvens AM, van Hesteren FHS, Cornelissen EAM, Bootsma-Robroeks CMHHT, Bruggemann RJM, Burger DM, de Wildt SN, Schreuder MF, Ter Heine R. The potential impact of hematocrit correction on evaluation of tacrolimus target exposure in pediatric kidney transplant patients. Pediatr Nephrol. 2019 Mar;34(3):507-515. doi: 10.1007/s00467-018-4117-x. Epub 2018 Oct 30.'}, {'pmid': '27320581', 'type': 'RESULT', 'citation': 'Limsrichamrern S, Chanapul C, Mahawithitwong P, Sirivatanauksorn Y, Kositamongkol P, Asavakarn S, Tovikkai C, Dumronggittigule W. Correlation of Hematocrit and Tacrolimus Level in Liver Transplant Recipients. Transplant Proc. 2016 May;48(4):1176-8. doi: 10.1016/j.transproceed.2015.12.096.'}]}, 'descriptionModule': {'briefSummary': 'Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis. Allograft rejection is a major issue in kidney transplantation. Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft', 'detailedDescription': 'The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF). Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers. Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Paediatric living donor kidney transplant recipients (aged 1-18 years)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Paediatric living donor kidney transplant recipients (aged 1-18 years)\n2. patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \\[mycophenolate mofetil (MMF) and steroids\n3. recipients with biopsy proven acute rejection in the studied group.\n\nExclusion Criteria:\n\n1. patients on cyclosporine\n2. patients with active infection and dehydration\n3. Patients who received multiorgan transplantation Non cooperative patient will be excluded'}, 'identificationModule': {'nctId': 'NCT04292418', 'briefTitle': 'Predictors of Rejection in Pediatric Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Predictors of Rejection in Pediatric Kidney Transplantation', 'orgStudyIdInfo': {'id': 'PKTX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group 1', 'description': '(rejector group )include Paediatric living donor kidney transplant recipients (aged 4-18 years) at least 35 child recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \\[mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the study group 1 measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test', 'interventionNames': ['Drug: Tacrolimus capsule , mycophenolic acid']}, {'label': 'study group 2', 'description': 'the second group (non rejector group ) include Paediatric living donor kidney transplant recipients (aged 4-18 years) recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug \\[mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the studied group at least 35 child measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test in the study group 2', 'interventionNames': ['Drug: Tacrolimus capsule , mycophenolic acid']}], 'interventions': [{'name': 'Tacrolimus capsule , mycophenolic acid', 'type': 'DRUG', 'description': 'measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2', 'armGroupLabels': ['study group 1', 'study group 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya Khalifa, master degree', 'role': 'CONTACT', 'email': 'dr.ayaahmedkhlifa@gmail.com', 'phone': '00201016228446'}, {'name': 'Doaa Salah, MD', 'role': 'CONTACT', 'email': 'doaamsalah2010@yahoo.com', 'phone': '002001205551924'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Aya Khalifa', 'investigatorAffiliation': 'Assiut University'}}}}