Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-03 @ 2:59 PM
Study NCT ID:
NCT02351427
Status:
UNKNOWN
Last Update Posted:
2015-02-04
First Post:
2015-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum creatinine', 'timeFrame': 'Day 14', 'description': "Investigators measure patients' serum creatinine at day 14."}], 'secondaryOutcomes': [{'measure': 'Incidence of steroid failure', 'timeFrame': 'Day 7', 'description': 'Steroid failure is defined as serum creatinine at day 8 ≥ serum creatinine at day 0.'}, {'measure': 'Serum creatinine', 'timeFrame': 'Month 1', 'description': "Investigators measure patients' serum creatinine at month 1."}, {'measure': 'Infection', 'timeFrame': 'Until 1 year after intervention', 'description': 'Infection as measured by clinical, laboratory and microbiological data'}, {'measure': 'Recurrence of Rejection', 'timeFrame': 'Until 1 year after intervention', 'description': 'Recurrence of rejection as measured by clinical and laboratory data with graft biopsy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '20826741', 'type': 'BACKGROUND', 'citation': 'Lemy A, Toungouz M, Abramowicz D. Bortezomib: a new player in pre- and post-transplant desensitization? Nephrol Dial Transplant. 2010 Nov;25(11):3480-9. doi: 10.1093/ndt/gfq502. Epub 2010 Sep 8.'}, {'pmid': '22336990', 'type': 'BACKGROUND', 'citation': 'Walsh RC, Alloway RR, Girnita AL, Woodle ES. Proteasome inhibitor-based therapy for antibody-mediated rejection. Kidney Int. 2012 Jun;81(11):1067-74. doi: 10.1038/ki.2011.502. Epub 2012 Feb 15.'}, {'pmid': '23195008', 'type': 'BACKGROUND', 'citation': 'Tzvetanov I, Spaggiari M, Joseph J, Jeon H, Thielke J, Oberholzer J, Benedetti E. The use of bortezomib as a rescue treatment for acute antibody-mediated rejection: report of three cases and review of literature. Transplant Proc. 2012 Dec;44(10):2971-5. doi: 10.1016/j.transproceed.2012.02.037.'}, {'pmid': '22836132', 'type': 'BACKGROUND', 'citation': 'Schmidt N, Alloway RR, Walsh RC, Sadaka B, Shields AR, Girnita AL, Hanseman DJ, Woodle ES. Prospective evaluation of the toxicity profile of proteasome inhibitor-based therapy in renal transplant candidates and recipients. Transplantation. 2012 Aug 27;94(4):352-61. doi: 10.1097/TP.0b013e318257acf6.'}, {'pmid': '21745166', 'type': 'BACKGROUND', 'citation': 'Hu X, Xu J, Sun A, Shen Y, He G, Guo F. Successful T-cell acute lymphoblastic leukemia treatment with proteasome inhibitor bortezomib based on evaluation of nuclear factor-kappaB activity. Leuk Lymphoma. 2011 Dec;52(12):2393-5. doi: 10.3109/10428194.2011.593271. Epub 2011 Jul 12. No abstract available.'}, {'pmid': '22770877', 'type': 'BACKGROUND', 'citation': 'Kim SJ, Yoon DH, Kang HJ, Kim JS, Park SK, Kim HJ, Lee J, Ryoo BY, Ko YH, Huh J, Yang WI, Kim HK, Min SK, Lee SS, Do IG, Suh C, Kim WS; Consortium for Improving Survival of Lymphoma (CISL) investigators. Bortezomib in combination with CHOP as first-line treatment for patients with stage III/IV peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 trial. Eur J Cancer. 2012 Nov;48(17):3223-31. doi: 10.1016/j.ejca.2012.06.003. Epub 2012 Jul 4.'}, {'pmid': '20535594', 'type': 'BACKGROUND', 'citation': "Zain JM, O'Connor O. Targeted treatment and new agents in peripheral T-cell lymphoma. Int J Hematol. 2010 Jul;92(1):33-44. doi: 10.1007/s12185-010-0614-9. Epub 2010 Jun 10."}, {'pmid': '22689676', 'type': 'BACKGROUND', 'citation': 'Arnulf B, Pylypenko H, Grosicki S, Karamanesht I, Leleu X, van de Velde H, Feng H, Cakana A, Deraedt W, Moreau P. Updated survival analysis of a randomized phase III study of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma. Haematologica. 2012 Dec;97(12):1925-8. doi: 10.3324/haematol.2012.067793. Epub 2012 Jun 11.'}, {'pmid': '19104417', 'type': 'RESULT', 'citation': 'Everly MJ, Everly JJ, Susskind B, Brailey P, Arend LJ, Alloway RR, Roy-Chaudhury P, Govil A, Mogilishetty G, Rike AH, Cardi M, Wadih G, Tevar A, Woodle ES. Bortezomib provides effective therapy for antibody- and cell-mediated acute rejection. Transplantation. 2008 Dec 27;86(12):1754-61. doi: 10.1097/TP.0b013e318190af83.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.', 'detailedDescription': 'When acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. However, there is insufficient effect in about 20-30%. Bortezomib acts not only on plasma cells, but also T cells, B cells and dendritic cells. In addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. Therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living donor kidney transplantation recipients\n* patients who were performed kidney biopsies because of laboratory and clinically suspected rejection\n* Biopsy proven acute cellular rejection (Banff I - IIA) with C4d negative\n* Single luminex panel reactive antibody (PRA) I \\& II mean fluorescent intensity (MFI) \\< 3000\n\nExclusion Criteria:\n\n* patients who received other major organ transplantation\n* combined with urinary tract infection or obstruction\n* combined with acute antibody mediated rejection\n* poor compliance'}, 'identificationModule': {'nctId': 'NCT02351427', 'briefTitle': 'Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney', 'orgStudyIdInfo': {'id': '2014-1223'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bortezomib', 'description': 'Bortezomib (subcutaneous) 1.3mg/m2 on day 1, 4 and 7\n\nwith\n\nSteroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage', 'interventionNames': ['Drug: Bortezomib', 'Drug: Steroid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid', 'description': 'Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage', 'interventionNames': ['Drug: Steroid']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Velcade'], 'description': 'In one group, investigators administer bortezomib and steroid to manage acute cellular rejection in kidney transplantation, and compare the results with another group in which only steroid was administered.', 'armGroupLabels': ['Bortezomib']}, {'name': 'Steroid', 'type': 'DRUG', 'description': 'Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.', 'armGroupLabels': ['Bortezomib', 'Steroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Su-Kil Park, M.D., PhD', 'role': 'CONTACT', 'email': 'skpark@amc.seoul.kr', 'phone': '82-2-3010-3263'}, {'name': 'Chung Hee Baek, M.D.', 'role': 'CONTACT', 'email': 'bch393@naver.com', 'phone': '82-2-3010-1481'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Su-Kil Park, M.D., PhD', 'role': 'CONTACT', 'email': 'skpark@amc.seoul.kr', 'phone': '82-2-3010-3263'}, {'name': 'Chung Hee Baek, M.D.', 'role': 'CONTACT', 'email': 'bch393@naver.com', 'phone': '82-2-3010-1481'}], 'overallOfficials': [{'name': 'Su-Kil Park, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Department of Internal Medicine, Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Su-Kil Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}