Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT01128335
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2010-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'C543528', 'term': 'sotrastaurin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2020-08-20', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2010-05-20', 'dispFirstSubmitQcDate': '2020-08-20', 'studyFirstSubmitQcDate': '2010-05-20', 'dispFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.', 'timeFrame': 'Month 6'}], 'secondaryOutcomes': [{'measure': 'Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).', 'timeFrame': 'Months 3, 6, 12, and 24'}, {'measure': 'Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.', 'timeFrame': 'Months 12, 24'}, {'measure': 'Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant', 'timeFrame': 'Months 6, 12, 24'}, {'measure': 'Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).', 'timeFrame': 'Months 3, 6, 12, 24'}]}, 'conditionsModule': {'keywords': ['Liver transplantation', 'HCV-negative recipient', 'deceased donor', 'sotrastaurin', 'oran transplantation', 'tacrolimus'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '25677074', 'type': 'RESULT', 'citation': 'Pascher A, De Simone P, Pratschke J, Salame E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8843', 'label': 'Results for CAEB071B2201 from the Novartis Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Recipients of any race, 18 years or older\n* Recipients of primary de novo orthotopic liver transplant from a deceased donor\n* Recipients of a kidney with a cold ischemia time \\< 30 hours\n* HCV-negative recipients\n\nExclusion criteria:\n\n* Prior organ/cellular transplant or multiple organ transplant\n* MELD-score \\> 35\n* HCC \\> Milan criteria\n* Donor age \\< 12 years\n* Cold ischemia \\> 15 hours\n* Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01128335', 'briefTitle': 'Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'CAEB071B2201'}, 'secondaryIdInfos': [{'id': '2007-001776-36'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'MMF(1000mg bid) + tacrolimus + standard of care medications', 'interventionNames': ['Drug: MMF(1000mg bid) + tacrolimus + standard of care medications']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'sotrastaurin (200mg bid) + tacrolimus + standard of care medications', 'interventionNames': ['Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'sotrastaurin (200mg bid) + tacrolimus + standard of care medications', 'interventionNames': ['Drug: sotrastaurin (200mg bid) + tacrolimus + standard of care medications']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'sotrastaurin (300 mg bid) + tacrolimus + standard of care medications', 'interventionNames': ['Drug: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications']}], 'interventions': [{'name': 'MMF(1000mg bid) + tacrolimus + standard of care medications', 'type': 'DRUG', 'description': 'MMF(1000mg bid) + tacrolimus + standard of care 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