Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-01-01 @ 3:20 AM
Study NCT ID:
NCT06901505
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'D006397', 'term': 'Hematinics'}, {'id': 'C000624313', 'term': 'vadadustat'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hemoglobin (Hb)', 'timeFrame': 'Baseline and the mean of Week 20 to 24'}], 'secondaryOutcomes': [{'measure': 'Number of participants reporting treatment-emergent serious adverse events (TESAEs)', 'timeFrame': 'Up to 29 Weeks'}, {'measure': 'Proportion of participants with mean Hb levels within target range', 'timeFrame': 'Week 16 to Week 24'}, {'measure': 'Proportion of participants receiving RBC transfusions', 'timeFrame': 'Up to 29 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Hemodialysis', 'Erythropoiesis-Stimulating Agent', 'Open-label', 'Vadadustat'], 'conditions': ['Anemia of Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the efficacy of vadadustat administered three times a week compared to standard of care erythropoiesis-stimulating agent for the treatment of anemia in in-center hemodialysis participants with end-stage kidney disease (ESKD). A subset of sites will participate in a red blood cell (RBC) sub-study where changes in the phenotype of RBCs in response to vadadustat treatment relative to methoxy polyethylene glycol-epoetin beta treatment in DD-CKD participants with anemia will be assessed. A separate informed consent form (ICF) will be signed by these participants who opt to be in the RBC sub-study. Of the 350 participants in the main study, approximately 28 participants will also be enrolled into the RBC sub-study. The total duration of the study is approximately 35 Weeks including screening and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants ≥18 years of age.\n* Receiving outpatient in-center hemodialysis for ESKD at least three times a week.\n* Currently prescribed or meets criteria for ESA based on approved facility policy.\n* Hb \\> 8 grams per deciliter (g/dl).\n* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20%.\n* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.\n* For selected sites, individuals who opt to participate in the RBC sub-study must meet the following inclusion criteria:\n* Currently prescribed or will be prescribed methoxy polyethylene glycol-epoetin beta.\n* Hb \\<11.5 g/dL\n\nExclusion Criteria:\n\n* Contraindication to receive vadadustat per United States prescribing information (USPI) as determined by the treating health care provider.\n* Concomitant use of any hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI).\n* Known cirrhosis or active, acute liver disease.\n* Unable to comply with study requirements or compliance with attending dialysis treatments as prescribed, or in the opinion of the treating physician or Investigator, not clinically stable to participate in the study.\n* Pregnant at the time of consent (per participant self-report).\n* Any other reason, which in the opinion of the Investigator, would make the participants unsuitable for participation in the study.\n* For selected sites, individuals who opt to participate in the RBC sub-study must also not meet the following exclusion criteria:\n* History of, or currently diagnosed with, any hematological disease, such as sickle cell disease, thalassemia, hemochromatosis, Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, myelodysplastic syndromes, or any other blood disorder that could interfere with the study outcomes.\n* Participants will receive a blood transfusion within 3 months prior to the initiation of the study.\n* History of or currently diagnosed with chronic lung disease'}, 'identificationModule': {'nctId': 'NCT06901505', 'briefTitle': 'To Evaluate the Efficacy of Three Times Weekly (TIW) Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akebia Therapeutics'}, 'officialTitle': 'A Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy of Three Times Weekly Vadadustat Compared to Standard of Care ESA in Patients With Anemia of CKD Receiving In-Center Hemodialysis', 'orgStudyIdInfo': {'id': 'AKB-6548-CI-0052'}, 'secondaryIdInfos': [{'id': 'VOCAL', 'type': 'OTHER', 'domain': 'Akebia Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vadadustat', 'description': 'Study drug will be administered three times a week.', 'interventionNames': ['Drug: Vadadustat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erythropoiesis-Stimulating Agent (ESA)', 'description': 'Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol', 'interventionNames': ['Drug: Erythropoiesis-Stimulating Agent (ESA)']}], 'interventions': [{'name': 'Erythropoiesis-Stimulating Agent (ESA)', 'type': 'DRUG', 'description': 'Administered by intra-venous (IV) infusion.', 'armGroupLabels': ['Erythropoiesis-Stimulating Agent (ESA)']}, {'name': 'Vadadustat', 'type': 'DRUG', 'otherNames': ['Vafseo', 'AKB-6548'], 'description': '300mg, oral tablets', 'armGroupLabels': ['Vadadustat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36117-7306', 'city': 'Montgomery', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '06112-1260', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06705-3893', 'city': 'Middlebury', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 41.52787, 'lon': -73.12761}}, {'zip': '31904-3604', 'city': 'Columbus', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '55435-1807', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site #1', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55435-1807', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89052-5548', 'city': 'Henderson', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89128-0804', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '79835-2200', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site #1', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '79835-2200', 'city': 'El Paso', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '77054-3836', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site #1', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054-3836', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78258-4800', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site #1', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258-4800', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site #2', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258-4800', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77384-3024', 'city': 'The Woodlands', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '23502-3235', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site #1', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23502-3235', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DaVita Research Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'centralContacts': [{'name': 'Akebia Therapeutics', 'role': 'CONTACT', 'email': 'trials@akebia.com', 'phone': '16178446128'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akebia Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}