Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-09 @ 9:29 PM
Study NCT ID:
NCT00682292
Status:
COMPLETED
Last Update Posted:
2008-05-22
First Post:
2008-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D000077561', 'term': 'Daclizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-02', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-21', 'studyFirstSubmitDate': '2008-05-20', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of biopsy-proven acute allograft rejection during the first post-transplant year', 'timeFrame': 'acute rejection proved by graft biopsy'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.', 'timeFrame': 'graft dysfunction'}, {'measure': 'Proportion of patients who experienced more than one episode of acute allograft rejection', 'timeFrame': 'graft dysfunction, biopsies'}, {'measure': 'Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)', 'timeFrame': 'number of anti-lymphocyte treatment required for acute rejection episodes'}, {'measure': 'Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm', 'timeFrame': 'graft dysfunction and biopsies'}, {'measure': 'Banff grade of the first rejection episode', 'timeFrame': 'graft biopsy'}, {'measure': 'Incidence of adverse events in the two treatment arms at 1 year', 'timeFrame': 'number of adverse events reported by the investigators'}, {'measure': 'Incidence of delayed graft function', 'timeFrame': 'number of patient who required hemodialysis during the first week post transplantation'}, {'measure': 'Graft function at 1 year', 'timeFrame': 'serum creatinine and estimated glomerular filtration rate'}, {'measure': 'Graft and patient survival at 1 year', 'timeFrame': 'number of graft failures and/or deaths'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Renal transplantation', 'Immunisation', 'Acute rejection', 'Induction therapy', 'Thymoglobulin', 'Daclizumab', 'Rejection in sensitized renal transplant recipients'], 'conditions': ['Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab.', 'detailedDescription': "The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year.\n\nEligible patients were randomized (1:1) to receive either ATG (1.25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Third or fourth renal graft or\n2. Current anti-HLA antibodies above or equal to 30% at the last evaluation or\n3. Peak anti-HLA antibodies above or equal to 50% at the last evaluation or\n4. A second graft if the first was lost within 2 years because of rejection.\n5. Patients who gave their informed consent and are able to understand the scope of the study\n\nExclusion Criteria:\n\n1. Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.\n2. Transplantation from a non-heart beating donor\n3. Transplantation of two kidneys from the same donor\n4. Patients with generalized infection at the time of transplantation\n5. Women in child-bearing age who do not plan to use efficient contraception'}, 'identificationModule': {'nctId': 'NCT00682292', 'acronym': 'TAXI', 'briefTitle': 'Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.', 'orgStudyIdInfo': {'id': 'UHLillle'}, 'secondaryIdInfos': [{'id': 'CRG020600038'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1, ATG', 'description': 'Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids', 'interventionNames': ['Drug: Thymoglobulin (ATG)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2, Daclizumab', 'description': 'Dacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids', 'interventionNames': ['Drug: Daclizumab']}], 'interventions': [{'name': 'Thymoglobulin (ATG)', 'type': 'DRUG', 'otherNames': ['Thymoglobulin, Genzyme'], 'description': 'Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation', 'armGroupLabels': ['1, ATG']}, {'name': 'Daclizumab', 'type': 'DRUG', 'otherNames': ['Zenapax, Roche'], 'description': 'Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation', 'armGroupLabels': ['2, Daclizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'University Hospital of Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Christian Noël, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Lille, France'}, {'name': 'Daniel Abramowicz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasme Hospital, Bruxelles, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasme University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Noël Christian, MD, PhD, Professor of Nephrology', 'oldOrganization': 'University Hospital of Lille'}}}}