Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT02432833
Status:
COMPLETED
Last Update Posted:
2018-04-13
First Post:
2015-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
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': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-12', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-05-01', 'lastUpdatePostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tacrolimus total daily dose (TDD) from week 3 to month 6', 'timeFrame': 'from week 3 to month 6'}], 'secondaryOutcomes': [{'measure': 'Tacrolimus blood trough level (TL).', 'timeFrame': 'from screening to months 6'}, {'measure': 'number of dose adjustment', 'timeFrame': 'from screening to months 6'}, {'measure': 'Occurrence of treatment failure', 'timeFrame': 'from screening to months 6'}, {'measure': 'Delayed graft function', 'timeFrame': 'from screening to months 6'}, {'measure': 'Acute rejection requiring treatment', 'timeFrame': 'from screening to months 6'}, {'measure': 'Consumption of concomitant immunosuppressant medications', 'timeFrame': 'from screening to months 6'}, {'measure': 'Treatment discontinuation', 'timeFrame': 'from screening to months 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '36017158', 'type': 'DERIVED', 'citation': 'Budde K, Rostaing L, Maggiore U, Piotti G, Surace D, Geraci S, Procaccianti C, Nicolini G, Witzke O, Kamar N, Albano L, Buchler M, Pascual J, Gutierrez-Dalmau A, Kuypers D, Wekerle T, Glyda M, Carmellini M, Tisone G, Midtvedt K, Wennberg L, Grinyo JM. Prolonged-Release Once-Daily Formulation of Tacrolimus Versus Standard-of-Care Tacrolimus in de novo Kidney Transplant Patients Across Europe. Transpl Int. 2022 Mar 21;35:10225. doi: 10.3389/ti.2021.10225. eCollection 2022.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004314-29/results', 'label': 'Study Record on EU Clinical Trials Register including results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a real-life setting in different European Countries.', 'detailedDescription': 'This is a Multicentre, Open label, Randomized, Two-arm, parallel-group study to assess efficacy and safety of Envarsus® compared with tacrolimus used as per current clinical practice in the initial maintenance setting in de novo kidney transplant patients. The study will be conducted in approximately 10 european countries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient's signed informed consent obtained prior to any study-related procedure;\n2. Adult men and women at least 18 years of age with end-stage renal disease who are recipients (or will be recipients) of a kidney transplant from a living or deceased donor;\n3. No known contraindications to the administration of tacrolimus, other macrolides and study drugs excipients;\n4. Patients must agree to use a highly reliable method of birth control;\n5. Donor-recipient negative cross match test, and compatible AB0 blood type;\n6. Able to swallow tablets and capsules\n\nExclusion Criteria:\n\n1. Recipient of any transplanted organ other than kidney;\n2. Recipient of a previous renal transplant;\n3. Recipient of a kidney from a donor after cardiac death;\n4. Recipient of a kidney from an AB0 incompatible or positive cross-match donor;\n5. Current (not older than 3 months) anti-HLA Panel Reactive Antibody (PRA) levels higher than 30%. Whenever PRA, either complement-dependent cytotoxicity-PRA or calculated PRA , is not available, patients who are positive on solid-phase screening assay for anti-HLA antibodies must not be enrolled;\n6. Recipient of a kidney with a cold ischemia time of ≥ 30 hours;\n7. White blood cells count ≤ 2.8x109 cells/L unless ANC \\>1.0x109/L;\n8. Platelet count \\< 50 x109 cells/L;\n9. ALT or AST levels \\>3 times the normal upper limit during the 30 days prior transplant procedure;\n10. Current abuse of drugs or alcohol;\n11. Incapable of understanding purpose and risk of study, unable to give written informed consent or unwilling to comply with study protocol;\n12. Treatment with any other investigational agent in the 30 days prior to enrolment;\n13. Kidney recipients and/or donors positive for HCV (HCV-RNA positive or HCV-Ab positive respectively);\n14. Kidney recipients and/or donors positive for HBV (HBV-DNA or HBS-Ag positive);\n15. Recipients positive for HIV;\n16. Patient or donor with current diagnosis or history of malignancy within the past 5 years except basal or non-metastatic squamous cell carcinoma of the skin successfully treated;\n17. Uncontrolled concomitant infection, systemic infection requiring treatment or any other unstable condition that could interfere with study objectives;\n18. Severe diarrhoea, vomiting, active peptic ulcer or GI disorder that may affect absorption of tacrolimus;\n19. Known hypersensitivity to tacrolimus other macrolides and study drugs excipients;\n20. Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use reliable methods of contraception"}, 'identificationModule': {'nctId': 'NCT02432833', 'acronym': 'STEADY', 'briefTitle': 'Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Farmaceutici S.p.A.'}, 'officialTitle': 'Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients', 'orgStudyIdInfo': {'id': 'CCD-06235AA1-01'}, 'secondaryIdInfos': [{'id': '2014-004314-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Envarsus® (tacrolimus)', 'description': 'prolonged-release tablets once daily and orally', 'interventionNames': ['Drug: ENVARSUS®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prograf or Advagraf', 'description': 'Prograf® hard capsules, twice daily, oral formulation or Advagraf® prolonged-release hard capsules, once daily, oral formulation', 'interventionNames': ['Drug: PROGRAF®', 'Drug: ADVAGRAF®']}], 'interventions': [{'name': 'ENVARSUS®', 'type': 'DRUG', 'description': 'Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus', 'armGroupLabels': ['Envarsus® (tacrolimus)']}, {'name': 'PROGRAF®', 'type': 'DRUG', 'description': 'Prograf® hard capsules, twice daily, oral formulation', 'armGroupLabels': ['Prograf or Advagraf']}, {'name': 'ADVAGRAF®', 'type': 'DRUG', 'description': 'Advagraf® prolonged-release hard capsules, once daily, oral formulation', 'armGroupLabels': ['Prograf or Advagraf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43123', 'city': 'Parma', 'country': 'Italy', 'facility': 'Chiesi farmaceutici Spa', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Klemens Budde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Farmaceutici S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}