Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 12:43 PM
Study NCT ID:
NCT01656135
Status:
COMPLETED
Last Update Posted:
2016-03-09
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Group Trial for The ONE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D015166', 'term': 'Monitoring, Immunologic'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune Monitoring (IM) assessment', 'timeFrame': '60 weeks'}, {'measure': 'Health Economics (HEC) assessment', 'timeFrame': '60 weeks'}], 'primaryOutcomes': [{'measure': 'biopsy-confirmed acute rejection incidence', 'timeFrame': '60 weeks'}], 'secondaryOutcomes': [{'measure': 'time to first acute rejection episode', 'timeFrame': 'within 60 weeks'}, {'measure': 'severity of acute rejection episodes', 'timeFrame': 'within 60 weeks'}, {'measure': 'total immunosuppressive burden', 'timeFrame': '60 weeks'}, {'measure': 'incidence of chronic graft dysfunction', 'timeFrame': '60 weeks'}, {'measure': 'incidence of graft loss through rejection', 'timeFrame': '60 weeks'}, {'measure': 'incidence of adverse drug reactions', 'timeFrame': '60 weeks'}, {'measure': 'incidence of major infections', 'timeFrame': '60 weeks'}, {'measure': 'incidence of neoplasia', 'timeFrame': '60 weeks'}, {'measure': 'incidence of patients treated for subclinical acute rejection', 'timeFrame': '60 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gold standard treatment', 'immune monitoring', 'acute rejection', 'graft rejection', 'living-donor', 'renal transplantation', 'kidney transplantation'], 'conditions': ['End-stage Renal Failure', 'Kidney Graft Rejection']}, 'referencesModule': {'references': [{'pmid': '36441083', 'type': 'DERIVED', 'citation': 'Sly LM, McKay DM. Macrophage immunotherapy: overcoming impediments to realize promise. Trends Immunol. 2022 Dec;43(12):959-968. doi: 10.1016/j.it.2022.10.002. Epub 2022 Oct 29.'}, {'pmid': '36306921', 'type': 'DERIVED', 'citation': 'Moreau A, Kervella D, Bouchet-Delbos L, Braudeau C, Saiagh S, Guerif P, Limou S, Moreau A, Bercegeay S, Streitz M, Sawitzki B, James B, Harden PN, Game D, Tang Q, Markmann JF, Roberts ISD, Geissler EK, Dreno B, Josien R, Cuturi MC, Blancho G; DIVAT consortium. A Phase I/IIa study of autologous tolerogenic dendritic cells immunotherapy in kidney transplant recipients. Kidney Int. 2023 Mar;103(3):627-637. doi: 10.1016/j.kint.2022.08.037. Epub 2022 Oct 26.'}, {'pmid': '32446407', 'type': 'DERIVED', 'citation': 'Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7.'}], 'seeAlsoLinks': [{'url': 'http://www.onestudy.org', 'label': 'The ONE Study'}]}, 'descriptionModule': {'briefSummary': 'To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOrgan Donor:\n\nA prospective donor is eligible for the research if all of the following inclusion criteria apply:\n\n1. Eligible for live kidney donation\n2. Aged at least 18 years\n3. An ABO blood type compatible with the organ recipient\n4. Willing and able to provide a blood sample for The ONE Study Subprojects\n5. Willing to provide personal and medical/biological data for the trial\n6. Signed and dated written informed consent.\n\nIn signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.\n\nOrgan Recipient:\n\n1. Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor\n2. Aged at least 18 years\n3. Able to commence the immunosuppressive regimen at the protocol-specified time point\n4. Willing and able to participate in The ONE Study subprojects\n5. Signed and dated written informed consent.\n\nExclusion Criteria:\n\nOrgan Donor:\n\nIf a prospective donor fulfils any of the following criteria, then they are ineligible for the trial:\n\n1. Genetically identical to the prospective organ recipient at the HLA loci\n2. Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation\n3. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel\n4. Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).\n\nOrgan Recipient:\n\n1. Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft\n2. Known sensitivity to tacrolimus, mycophenolate, or corticosteroids\n3. Genetically identical to the prospective organ donor at the HLA loci\n4. PRA grade \\> 40% within 6 months prior to enrolment\n5. Previous treatment with any desensitisation procedure (with or without IVIg)\n6. Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)\n7. Evidence of significant local or systemic infection\n8. HIV-positive, EBV-negative or suffering chronic viral hepatitis\n9. Significant liver disease, defined as persistently elevated AST and/or ALT levels \\>2 x ULN (Upper Limit of Normal range)\n10. Malignant or pre-malignant haematological conditions\n11. Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives\n12. Any condition which, in the judgement of the Investigator, would place the subject at undue risk\n13. Ongoing treatment with systemic immunosuppressive drugs at study entry\n14. Participation in another clinical trial during the study or within 28 days prior to planned study entry\n15. Female patients of child-bearing potential with a positive pregnancy test at enrolment\n16. Female patients who are breast-feeding\n17. All female patients of child-bearing potential UNLESS:\n\n 1. The patient is willing to maintain a highly effective method of birth control for the duration of the study\n 2. The career, lifestyle, or sexual orientation of the patient ensures that there is no risk of pregnancy for the duration of the study (at the discretion of the local Investigator)\n18. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule\n19. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel\n20. Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).'}, 'identificationModule': {'nctId': 'NCT01656135', 'briefTitle': 'Reference Group Trial for The ONE Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation', 'orgStudyIdInfo': {'id': 'ONErgt11'}, 'secondaryIdInfos': [{'id': '260687', 'type': 'OTHER_GRANT', 'domain': 'EU FP7 Programme'}, {'id': '2011-004301-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Reference Group', 'description': 'Basiliximab (Simulect®):\n\n* Day 0: 20mg IV ≤2h prior to surgery\n* Day 4: 20mg IV\n\nPrednisolone:\n\n* Day 0: 500mg IV (250mg pre-op, 250mg intra-op)\n* Day 1: 125mg IV\n* Day 2 - 14: 20mg/day oral\n* Week 3 - 4: 15mg/day oral\n* Week 5 - 8: 10mg/day oral\n* Week 9 - 12: 5mg/day oral\n* Week 13 - 14: 2.5mg/day oral\n* Week 15 - Study End: Cessation\n\nSteroid tapering should not proceed if graft rejection has occurred or if renal dysfunction is observed.\n\nMycophenolate Mofetil (MMF, or biologic equivalent):\n\nTreatment with MMF should commence one day prior to transplantation (on Day -1) and should continue indefinitely, with a dose reduction after two weeks:\n\n* Day -1 - 14: 2g/day oral\n* Day 15 - Study End 1.5g/day oral (750mg twice daily)\n\nTacrolimus (or biologic equivalent):\n\n* Day -4 - 14: 3-12ng/ml\n* Week 3 - 12: 3-10ng/ml\n* Week 13 - 36: 3-8ng/ml\n* Week 37 - Study End: 3-6ng/ml', 'interventionNames': ['Other: Blood drawing for immune monitoring and questionnaires']}], 'interventions': [{'name': 'Blood drawing for immune monitoring and questionnaires', 'type': 'OTHER', 'armGroupLabels': ['Reference Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes Hotel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Hospital Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital in affiliation with King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital in affiliation with the University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Edward K. Geissler, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Investigator and EU Project Leader', 'investigatorFullName': 'Edward Geissler', 'investigatorAffiliation': 'University of Regensburg'}}}}