Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-06-25 @ 5:16 AM
Study NCT ID:
NCT02876692
Status:
UNKNOWN
Last Update Posted:
2016-09-01
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051799', 'term': 'Delayed Graft Function'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'delayed graft function', 'timeFrame': '7 days after renal transplant'}, {'measure': 'Transplant nephrectomy', 'timeFrame': '1 year after reanl transplant'}], 'secondaryOutcomes': [{'measure': 'Abnormal serum creatinine', 'timeFrame': 'Serum creatinine did not return to the normal range within the first 30 days'}, {'measure': 'Renal dysfunction caused by the acute rejection', 'timeFrame': 'within the first 3 months'}, {'measure': 'lung infection lead to death', 'timeFrame': 'within the first 1 year'}, {'measure': 'Renal dysfunction caused by Surgical complications', 'timeFrame': 'within the first 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Delayed Graft Function']}, 'referencesModule': {'references': [{'pmid': '24731165', 'type': 'BACKGROUND', 'citation': 'Allen AM, Kim WR, Xiong H, Liu J, Stock PG, Lake JR, Chinnakotla S, Snyder JJ, Israni AK, Kasiske BL. Survival of recipients of livers from donation after circulatory death who are relisted and undergo retransplant for graft failure. Am J Transplant. 2014 May;14(5):1120-8. doi: 10.1111/ajt.12700. Epub 2014 Apr 14.'}, {'pmid': '22078722', 'type': 'BACKGROUND', 'citation': 'Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. A pilot programme of organ donation after cardiac death in China. Lancet. 2012 Mar 3;379(9818):862-5. doi: 10.1016/S0140-6736(11)61086-6. Epub 2011 Nov 10.'}, {'pmid': '23743728', 'type': 'BACKGROUND', 'citation': 'Huang J, Wang H, Fan ST, Zhao B, Zhang Z, Hao L, Huo F, Liu Y. The national program for deceased organ donation in China. Transplantation. 2013 Jul 15;96(1):5-9. doi: 10.1097/TP.0b013e3182985491.'}, {'pmid': '20664493', 'type': 'BACKGROUND', 'citation': 'World Health Organization. WHO guiding principles on human cell, tissue and organ transplantation. Transplantation. 2010 Aug 15;90(3):229-33. doi: 10.1097/TP.0b013e3181ec29f0. No abstract available.'}, {'pmid': '17263786', 'type': 'BACKGROUND', 'citation': 'Moers C, Leuvenink HG, Ploeg RJ. Non-heart beating organ donation: overview and future perspectives. Transpl Int. 2007 Jul;20(7):567-75. doi: 10.1111/j.1432-2277.2007.00455.x. Epub 2007 Jan 30.'}, {'pmid': '17496535', 'type': 'BACKGROUND', 'citation': 'Kokkinos C, Antcliffe D, Nanidis T, Darzi AW, Tekkis P, Papalois V. Outcome of kidney transplantation from nonheart-beating versus heart-beating cadaveric donors. Transplantation. 2007 May 15;83(9):1193-9. doi: 10.1097/01.tp.0000261710.53848.51.'}, {'pmid': '22694305', 'type': 'BACKGROUND', 'citation': 'Jochmans I, Darius T, Kuypers D, Monbaliu D, Goffin E, Mourad M, Ledinh H, Weekers L, Peeters P, Randon C, Bosmans JL, Roeyen G, Abramowicz D, Hoang AD, De Pauw L, Rahmel A, Squifflet JP, Pirenne J. Kidney donation after circulatory death in a country with a high number of brain dead donors: 10-year experience in Belgium. Transpl Int. 2012 Aug;25(8):857-66. doi: 10.1111/j.1432-2277.2012.01510.x. Epub 2012 Jun 13.'}, {'pmid': '19857774', 'type': 'BACKGROUND', 'citation': 'Chamorro C, Falcon JA, Michelena JC. Controversial points in organ donor management. Transplant Proc. 2009 Oct;41(8):3473-5. doi: 10.1016/j.transproceed.2009.09.004.'}, {'pmid': '2225301', 'type': 'BACKGROUND', 'citation': 'Gelb AW, Robertson KM. Anaesthetic management of the brain dead for organ donation. Can J Anaesth. 1990 Oct;37(7):806-12. doi: 10.1007/BF03006543.'}, {'pmid': '22893495', 'type': 'RESULT', 'citation': 'Xue W, Tian P, Ding X, Pan X, Yan H, Hou J, Feng X, Xiang H, Tian X, Ren L, Zheng J, Li S. Clinical research and social status investigation for donor and recipient of living-related kidney transplant. Int Urol Nephrol. 2013 Feb;45(1):239-49. doi: 10.1007/s11255-012-0259-0. Epub 2012 Aug 15.'}, {'pmid': '23778649', 'type': 'RESULT', 'citation': 'Wadei HM, Heckman MG, Rawal B, Taner CB, Farahat W, Nur L, Mai ML, Prendergast M, Gonwa TA. Comparison of kidney function between donation after cardiac death and donation after brain death kidney transplantation. Transplantation. 2013 Aug 15;96(3):274-81. doi: 10.1097/TP.0b013e31829807d1.'}, {'pmid': '20331689', 'type': 'RESULT', 'citation': 'Singh RP, Farney AC, Rogers J, Zuckerman J, Reeves-Daniel A, Hartmann E, Iskandar S, Adams P, Stratta RJ. Kidney transplantation from donation after cardiac death donors: lack of impact of delayed graft function on post-transplant outcomes. Clin Transplant. 2011 Mar-Apr;25(2):255-64. doi: 10.1111/j.1399-0012.2010.01241.x.'}, {'pmid': '24056620', 'type': 'RESULT', 'citation': 'Mallon DH, Summers DM, Bradley JA, Pettigrew GJ. Defining delayed graft function after renal transplantation: simplest is best. Transplantation. 2013 Nov 27;96(10):885-9. doi: 10.1097/TP.0b013e3182a19348.'}, {'pmid': '23154212', 'type': 'RESULT', 'citation': 'Nagaraja P, Roberts GW, Stephens M, Horvath S, Fialova J, Chavez R, Asderakis A, Kaposztas Z. Influence of delayed graft function and acute rejection on outcomes after kidney transplantation from donors after cardiac death. Transplantation. 2012 Dec 27;94(12):1218-23. doi: 10.1097/TP.0b013e3182708e30.'}, {'pmid': '22823748', 'type': 'RESULT', 'citation': 'Lodhi SA, Lamb KE, Uddin I, Meier-Kriesche HU. Pulsatile pump decreases risk of delayed graft function in kidneys donated after cardiac death. Am J Transplant. 2012 Oct;12(10):2774-80. doi: 10.1111/j.1600-6143.2012.04179.x. Epub 2012 Jul 23.'}]}, 'descriptionModule': {'briefSummary': "This is a prospective cohort study:\n\n1. First step: to establish a new scoring system for predication of delayed graft function(DGF) following kidney transplantation based on previous and new study data. The new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and kidney evaluation System based on Lifeport platform ).\n2. Second step: validate the new scoring system through prospective cohort study in our transplantation center and modify the scoring system if needed. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft survival and patient survival\n3. Step 3: Further validate the new scoring system in six other transplantation centers and developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF, AR, graft survival and patient survival", 'detailedDescription': 'Subjects are enrolled to collect the data of donors and recipients. Investigators also collect the data of recipients or donated organs as following: physiological and biochemical indexes, machine perfusion parameters, and the other factors effected on renal transplant outcomes. A Cox proportional hazards model and multiple linear regression analysis will be applied to examine the correlation among the univariate and multivariate. Based on the above analysis to improve the new scoring system, Lifeport work platform evaluation system and donor kidney quality evaluation system. Then, a multi-center clinical trial will be started to improve and verify the new scoring system. Finally, a donor kidney evaluation APP will be developed based on the scoring system and the database of clinical trials. An applicaiotion (APP) will be popularized the national transplant surgeons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients assigned the deceased donor kidney to transplant in the waiting list.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDonor\n\n* 1\\. Comply with the national donation after citizen death guideline\n* 2\\. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior\n* 3\\. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered\n* 4\\. No activity of untreated systemic bacterial, viral or fungal infection;\n* 5\\. Patients definitely identified\n\nRecipient:\n\n* 1\\. 65 y old ≥Age\\> = 18 years old, male or female\n* 2\\. BMI\\<26\n* 3\\. Renal transplantation first time\n* 4\\. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.\n* 5\\. Before the clinical trial, Patient sign informed consent voluntarily\n\nExclusion Criteria:\n\nDonor\n\n* 1\\. Older than 65 years old\n* 2.Serum hepatitis B virus (HBV), hepatitis C virus (HCV), HIV positive\n* 3.Donor kidney cold storage time over 30 hours\n* 4.Warm ischemia time over 20 minutes\n* 5.Other reagents are added perfusion for regulation of donor renal function\n\nRecipient:\n\n* 1.Involved in other study.\n* 2.Double organ or multi-organ transplant\n* 3.A,B,O blood type-incompatible'}, 'identificationModule': {'nctId': 'NCT02876692', 'acronym': "Xi'anCri", 'briefTitle': 'Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform', 'orgStudyIdInfo': {'id': 'XAC-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Machine perfusion', 'type': 'DEVICE', 'description': 'Deceased donor kidneys were preserved by hypothermic machine perfusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chenguang Ding, PhD', 'role': 'CONTACT', 'email': 'doctor_ding@126.com'}], 'facility': "First Affiliated Hospital Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Chenguang D Ding, PhD', 'role': 'CONTACT', 'email': 'doctor_ding@126.com', 'phone': '8602985323721'}, {'name': 'Xiaoming D Ding, PhD', 'role': 'CONTACT', 'email': 'xmding@mail.xju.edu.cn', 'phone': '8602985323721'}], 'overallOfficials': [{'name': 'xiaoming D Ding, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of renal transplant department', 'investigatorFullName': 'Ding Xiaoming', 'investigatorAffiliation': "First Affiliated Hospital Xi'an Jiaotong University"}}}}