Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT04414735
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2020-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017893', 'term': 'Photopheresis'}], 'ancestors': [{'id': 'D011701', 'term': 'PUVA Therapy'}, {'id': 'D014467', 'term': 'Ultraviolet Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Unicentric, randomized, open study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2020-05-30', 'studyFirstSubmitQcDate': '2020-05-30', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first histological rejection in the first year of kidney transplantation.', 'timeFrame': '1 year after kidney transplantation', 'description': 'Time to first histological rejection in the first year of kidney transplantation.'}], 'secondaryOutcomes': [{'measure': 'Biopsy proved acute rejection', 'timeFrame': '1 year after kidney transplantation'}, {'measure': 'Glomerular filtrate rate at one year after kidney transplant', 'timeFrame': '1 year after kidney transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Transplant Rejection', 'photopheresis', 'Antibody-mediated rejection', 'Chronic active antibody-mediated rejection'], 'conditions': ['Kidney Transplant Rejection']}, 'referencesModule': {'references': [{'pmid': '24768429', 'type': 'BACKGROUND', 'citation': 'Jaksch P, Knobler R. ECP and solid organ transplantation. Transfus Apher Sci. 2014 Jun;50(3):358-62. doi: 10.1016/j.transci.2014.04.006. Epub 2014 Apr 13.'}, {'pmid': '24837416', 'type': 'BACKGROUND', 'citation': 'Heshmati F. Updating ECP action mechanisms. Transfus Apher Sci. 2014 Jun;50(3):330-9. doi: 10.1016/j.transci.2014.04.003. Epub 2014 Apr 13.'}, {'pmid': '1498142', 'type': 'BACKGROUND', 'citation': 'Rose EA, Barr ML, Xu H, Pepino P, Murphy MP, McGovern MA, Ratner AJ, Watkins JF, Marboe CC, Berger CL. Photochemotherapy in human heart transplant recipients at high risk for fatal rejection. J Heart Lung Transplant. 1992 Jul-Aug;11(4 Pt 1):746-50.'}, {'pmid': '9845709', 'type': 'BACKGROUND', 'citation': "Barr ML, Meiser BM, Eisen HJ, Roberts RF, Livi U, Dall'Amico R, Dorent R, Rogers JG, Radovancevic B, Taylor DO, Jeevanandam V, Marboe CC. Photopheresis for the prevention of rejection in cardiac transplantation. Photopheresis Transplantation Study Group. N Engl J Med. 1998 Dec 10;339(24):1744-51. doi: 10.1056/NEJM199812103392404."}, {'pmid': '10770423', 'type': 'BACKGROUND', 'citation': 'Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, Rose EA. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000 Apr;14(2):162-6. doi: 10.1034/j.1399-0012.2000.140211.x.'}, {'pmid': '16507420', 'type': 'BACKGROUND', 'citation': 'Kirklin JK, Brown RN, Huang ST, Naftel DC, Hubbard SM, Rayburn BK, McGiffin DC, Bourge RB, Benza RL, Tallaj JA, Pinderski LJ, Pamboukian SV, George JF, Marques M. Rejection with hemodynamic compromise: objective evidence for efficacy of photopheresis. J Heart Lung Transplant. 2006 Mar;25(3):283-8. doi: 10.1016/j.healun.2005.10.004. Epub 2006 Jan 25.'}, {'pmid': '28457374', 'type': 'BACKGROUND', 'citation': 'Pecoraro Y, Carillo C, Diso D, Mantovani S, Cimino G, De Giacomo T, Troiani P, Shafii M, Gherzi L, Amore D, Rendina EA, Venuta F, Anile M. Efficacy of Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome After Lung Transplantation. Transplant Proc. 2017 May;49(4):695-698. doi: 10.1016/j.transproceed.2017.02.035.'}, {'pmid': '22884382', 'type': 'BACKGROUND', 'citation': 'Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.'}, {'pmid': '21996194', 'type': 'BACKGROUND', 'citation': 'Kusztal M, Koscielska-Kasprzak K, Gdowska W, Zabinska M, Myszka M, Klak R, Krajewska M, Boratynska M, Szyber P, Chudoba P, Patrzalek D, Klinger M. Extracorporeal photopheresis as an antirejection prophylaxis in kidney transplant recipients: preliminary results. Transplant Proc. 2011 Oct;43(8):2938-40. doi: 10.1016/j.transproceed.2011.08.061.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).\n\nUnicentric, randomized, open study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation\n* Recipients between 18 and 75 years old\n* Patients are able to understand and sign informed consent (Annex 1).\n\nExclusion Criteria:\n\n* Participation in another interventional clinical trial.\n* Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours post-transplant.\n* Persons with any dependency on the researcher or employee by the responsible institution or researcher. As well as people detained by legal order.'}, 'identificationModule': {'nctId': 'NCT04414735', 'briefTitle': 'Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Clinic per a la Recerca Biomédica'}, 'officialTitle': 'Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'HCB/2018/0853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1- Control group (Standard immunosuppression)', 'description': '1- Control group (n=15): Standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate), according to the clinical protocol of the Nephrology and Kidney Transplant Department.'}, {'type': 'EXPERIMENTAL', 'label': '2- Treatment group (ECP+Standard immunosuppression)', 'description': '2- Treatment group (n=15): Extracorporeal photopheresis in combination with standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate) according to the clinical protocol of the Nephrology and Kidney Transplant Department', 'interventionNames': ['Other: Extracorporeal Photopheresis']}], 'interventions': [{'name': 'Extracorporeal Photopheresis', 'type': 'OTHER', 'description': 'Infusion of autologous cellular products exposed to ultraviolet light (UV), in the presence of a photosensitizer. The cellular product is obtained through leucopheresis and its subsequent exposure to 8-methoxypsoralen (8-MOP) and irradiation with UV-A light.', 'armGroupLabels': ['2- Treatment group (ECP+Standard immunosuppression)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Please Select', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Gastón J Piñeiro, MD', 'role': 'CONTACT', 'email': 'gjpineir@clinic.cat'}, {'name': 'Fritz Diekmann, MD, PhD', 'role': 'CONTACT', 'email': 'fdiekman@clinic.cat', 'phone': '+34932275400', 'phoneExt': '5444'}, {'name': 'Gastón J Piñeiro, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fritz Diekmann, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jordi Rovira, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pedro Ventura, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Deparment of Nephology and Kidney Transplant', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Diekmann', 'role': 'CONTACT', 'email': 'fdiekman@clinic.cat', 'phone': '+34932275400', 'phoneExt': '5444'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Experimental Laboratory of Nephrology and Transplantation (LENIT)', 'investigatorFullName': 'Fritz Diekmann', 'investigatorAffiliation': 'Fundacion Clinic per a la Recerca Biomédica'}}}}