Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT00492869
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2007-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543528', 'term': 'sotrastaurin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'dispFirstSubmitDate': '2020-08-20', 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2007-06-26', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2007-06-26', 'dispFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms'}], 'secondaryOutcomes': [{'measure': 'Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies'}]}, 'conditionsModule': {'keywords': ['kidney transplantation', 'rejection', 'AEB071', 'tacrolimus', 'mycophenolic', 'basiliximab', 'immunosuppression'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '21564523', 'type': 'DERIVED', 'citation': 'Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2801', 'label': 'Results for CAEB071A2207 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Male and female patients of any race 18 years or older\n* Adult recipients of kidney transplant from a deceased or living donor\n* Recipients of a functioning kidney within 24 hours post transplant\n\nExclusion:\n\n* Need for medication prohibited by the protocol\n* Patients or donors infected with Hepatitis B,C or HIV\n* Patients with a history of cancer within last 5 years\n* Patients with history of significant cardiac disorder\n* Patients of high-risk immunological status\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00492869', 'briefTitle': 'Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'CAEB071A2207'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AEB071', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103-8401', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Science Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Lifelink, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, 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