Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-20 @ 2:46 PM
Study NCT ID:
NCT03242967
Status:
WITHDRAWN
Last Update Posted:
2018-11-05
First Post:
2017-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624313', 'term': 'vadadustat'}, {'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Revised study design.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in Hb between baseline and the primary evaluation period', 'timeFrame': 'Baseline visit, Week 36', 'description': 'Mean change in hemoglobin will be evaluated'}], 'secondaryOutcomes': [{'measure': 'Mean change in Hb between baseline and the secondary evaluation period', 'timeFrame': 'Baseline visit, Week 52', 'description': 'Mean change in hemoglobin will be evaluated'}, {'measure': 'Proportion of subjects with mean Hb within the target range during the primary evaluation period', 'timeFrame': 'Baseline visit, Week 36', 'description': 'Hemoglobin values within the target range will be evaluated'}, {'measure': 'Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '52 weeks', 'description': 'Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anemia', 'hemoglobin', 'darbepoetin alfa', 'TIW', 'hypoxia-inducible factor prolyl-hydroxylase inhibitor', 'HIF-PHI', 'AKB-6548', 'vadadustat', 'renal', 'hypoxia-inducible factor', 'HIF', 'dialysis-dependent chronic kidney disease', 'CKD', 'DD-CKD', 'kidney', 'erythropoiesis stimulating agent', 'ESA'], 'conditions': ['Anemia', 'Dialysis-Dependent Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects ≥18 years of age\n* Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease\n* Currently maintained on ESA therapy\n* Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)\n\nExclusion Criteria:\n\n* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss\n* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia\n* Red blood cell transfusion within 4 weeks prior to or during screening\n* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation'}, 'identificationModule': {'nctId': 'NCT03242967', 'acronym': 'TRILOGY', 'briefTitle': 'Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)', 'orgStudyIdInfo': {'id': 'AKB-6548-CI-0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vadadustat', 'description': 'Oral tablet', 'interventionNames': ['Drug: Vadadustat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Darbepoetin alfa', 'description': 'subcutaneous or intravenous', 'interventionNames': ['Drug: Darbepoetin alfa']}], 'interventions': [{'name': 'Vadadustat', 'type': 'DRUG', 'otherNames': ['AKB-6548'], 'description': 'Oral tablet', 'armGroupLabels': ['Vadadustat']}, {'name': 'Darbepoetin alfa', 'type': 'DRUG', 'otherNames': ['Aranesp'], 'description': 'subcutaneous or intravenous', 'armGroupLabels': ['Darbepoetin alfa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}], 'overallOfficials': [{'name': 'Akebia Therapeutics', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akebia Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}