Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:38 PM
Study NCT ID:
NCT03543657
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maintenance Treatment of Renal Anemia in Dialysis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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': 'C000603972', 'term': 'molidustat'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean Hb level during the evaluation period', 'timeFrame': 'From week 33 to 36'}, {'measure': 'The change in mean Hb level during the evaluation period from baseline', 'timeFrame': 'Baseline and week 33 to 36'}], 'secondaryOutcomes': [{'measure': 'Responder rate: proportion of responders among the subjects', 'timeFrame': 'From week 33 to 36', 'description': 'Responder is defined as meeting all of the following criteria:\n\n(i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment'}, {'measure': 'Proportion of subjects who meet each component of the response', 'timeFrame': 'From week 33 to 36', 'description': 'Response:\n\n(i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment'}, {'measure': 'Hb level', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Change in Hb level', 'timeFrame': 'Baseline and up to 52 weeks'}, {'measure': 'Proportion of subjects whose mean hemoglobin level is in the target range', 'timeFrame': 'From week 33 to 36'}, {'measure': 'Proportion of subjects whose mean hemoglobin level is above the target range', 'timeFrame': 'From week 33 to 36'}, {'measure': 'Proportion of subjects whose mean hemoglobin level is below the target range', 'timeFrame': 'From week 33 to 36'}, {'measure': 'Proportion of subjects with hemoglobin levels in the target range', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Proportion of subjects with hemoglobin levels above the target range', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Proportion of subjects with hemoglobin levels below the target range', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week', 'timeFrame': 'Up to 52 weeks', 'description': 'Defined as change in Hb level / duration between two visits (weeks)'}, {'measure': 'Number of participants with serious adverse events', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'At baseline, week 8, week 24 and week 52'}, {'measure': 'Area under the concentration-time curve (AUC)', 'timeFrame': 'At baseline, week 8, week 24 and week 52'}, {'measure': 'EPO (Erythropoietin) serum concentration', 'timeFrame': 'At baseline, week 8, week 24 and week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia', 'Renal Insufficiency, Chronic']}, 'referencesModule': {'references': [{'pmid': '36005278', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.'}, {'pmid': '31203241', 'type': 'DERIVED', 'citation': 'Akizawa T, Taguchi M, Matsuda Y, Iekushi K, Yamada T, Yamamoto H. Molidustat for the treatment of renal anaemia in patients with dialysis-dependent chronic kidney disease: design and rationale of three phase III studies. BMJ Open. 2019 Jun 14;9(6):e026602. doi: 10.1136/bmjopen-2018-026602.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with ESKD (end-stage kidney disease) on regular dialysis (including, hemodiafiltration, hemofiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly for at least 12 weeks prior to randomization\n* Body weight (after dialysis) \\> 40 and ≤ 160 kg at screening\n* Male or female subject ≥ 20 years of age at screening\n* At least one kidney\n* Treated with weekly or bi-weekly dose of darbepoetin alfa, monthly or bi-weekly dose of epoetin beta pegol, OR weekly, biweekly, twice or three times per week dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to randomization\n* Mean screening Hb level ≥ 9.5 and \\< 12.0 g/dL (mean of all central laboratory Hb levels before dialysis \\[at least 2 measurements must be taken ≥ 2 days apart\\] during the screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is \\< 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization\n* Ferritin ≥ 100 ng/mL or transferrin saturation ≥ 20% at screening\n* Serum folate level and serum vitamin B12 level above lower limit of normal (LLN) at screening\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) Class III or IV congestive heart failure\n* History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization\n* Sustained, poorly controlled arterial hypertension (defined as systolic BP (blood pressure) ≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP \\< 90mmHg) at randomization\n* Proliferative choroidal or retinal disease, such as neovascular agerelated macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation) at screening'}, 'identificationModule': {'nctId': 'NCT03543657', 'acronym': 'MIYABI HD-M', 'briefTitle': 'Maintenance Treatment of Renal Anemia in Dialysis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)', 'orgStudyIdInfo': {'id': '19352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Molidustat group', 'description': 'Subjects in the molidustat group will receive molidustat and darbepoetin alfa placebo.', 'interventionNames': ['Drug: Molidustat (BAY85-3934)', 'Drug: Placebo of Darbepoetin alfa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Darbepoetin alfa group', 'description': 'Subjects in the darbepoetin alfa group will receive molidustat placebo and darbepoetin alfa.', 'interventionNames': ['Drug: Darbepoetin alfa', 'Drug: Placebo of Molidustat (BAY85-3934)']}], 'interventions': [{'name': 'Molidustat (BAY85-3934)', 'type': 'DRUG', 'description': "Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).", 'armGroupLabels': ['Molidustat group']}, {'name': 'Darbepoetin alfa', 'type': 'DRUG', 'description': "Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.", 'armGroupLabels': ['Darbepoetin alfa group']}, {'name': 'Placebo of Molidustat (BAY85-3934)', 'type': 'DRUG', 'description': 'Matching placebo of Molidustat.', 'armGroupLabels': ['Darbepoetin alfa group']}, {'name': 'Placebo of Darbepoetin alfa', 'type': 'DRUG', 'description': 'Matching placebo of Darbepoetin alfa.', 'armGroupLabels': ['Molidustat group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '465-0025', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Hakuyoukai Medical corporation Hakuyoukai Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-0084', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Shinkashiwa Clinic', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '292-0805', 'city': 'Kisarazu', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Kisarazu Clinic', 'geoPoint': {'lat': 35.38329, 'lon': 139.93254}}, {'zip': '792-0812', 'city': 'Niihama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Kuwajima Clinic', 'geoPoint': {'lat': 33.96047, 'lon': 133.30522}}, {'zip': '916-0044', 'city': 'Sabae', 'state': 'Fukui', 'country': 'Japan', 'facility': 'Sabae kidney Clinic', 'geoPoint': {'lat': 35.94647, 'lon': 136.18498}}, {'zip': '811-0120', 'city': 'Kasuya-gun', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Houshikai Kano hospital'}, {'zip': '805-0050', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Saiseikai Yahata General Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '379-2311', 'city': 'Midori', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Sanshikai Toho Hospital', 'geoPoint': {'lat': 36.44492, 'lon': 139.28448}}, {'zip': '078-8211', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Asahikawa-Kosei General Hospital', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '066-0062', 'city': 'Chitose', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Koizumi Cardiology Medical Clinic', 'geoPoint': {'lat': 42.81944, 'lon': 141.65222}}, {'zip': '061-3213', 'city': 'Ishikari', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Ishikari Hospital', 'geoPoint': {'lat': 43.23972, 'lon': 141.35389}}, {'zip': '059-0026', 'city': 'Noboribetsu', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Itami Kidney Clinic', 'geoPoint': {'lat': 42.45215, 'lon': 141.17914}}, {'zip': '060-0008', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Souen Central Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '309-1793', 'city': 'Kasama', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Ibaraki Prefectural Central Hospital', 'geoPoint': {'lat': 36.38333, 'lon': 140.26667}}, {'zip': '306-0014', 'city': 'Koga', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Japanese Red Cross Koga Hospital', 'geoPoint': {'lat': 36.18333, 'lon': 139.71667}}, {'zip': '310-0015', 'city': 'Mito', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Mito Kyodo General Hospital', 'geoPoint': {'lat': 36.35, 'lon': 140.45}}, {'zip': '302-0011', 'city': 'Totte', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tokiwa Clinic'}, {'zip': '300-0062', 'city': 'Tsuchiura', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tsuchiura Beryl Clinic', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'zip': '305-0861', 'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Kikuchi Medical Clinic', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '924-8588', 'city': 'Hakusan', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Public Central Hospital of Matto Ishikawa', 'geoPoint': {'lat': 36.48204, 'lon': 136.58684}}, {'zip': '762-0007', 'city': 'Sakaidechō', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'Kaisei Hospital', 'geoPoint': {'lat': 34.32278, 'lon': 133.8356}}, {'zip': '243-0013', 'city': 'Atsugi', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Honatsugi Medical Clinic', 'geoPoint': {'lat': 35.44272, 'lon': 139.36931}}, {'zip': '253-0052', 'city': 'Chigasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Chigasaki Central Clinic', 'geoPoint': {'lat': 35.33638, 'lon': 139.40434}}, {'zip': '252-0385', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Toshiba Rinkan Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '224-0032', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama Jin Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '225-0015', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Eda Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '233-0013', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Kaminagaya Saitou Clinic', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '981-3632', 'city': 'Kurokawa-gun', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Seisuikai Yoshioka Mahoroba Clinic'}, {'zip': '989-6117', 'city': 'Ōsaki', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Eijinkai Hospital', 'geoPoint': {'lat': 38.58866, 'lon': 140.973}}, {'zip': '395-8505', 'city': 'Iida', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Iida Hospital', 'geoPoint': {'lat': 35.51965, 'lon': 137.82074}}, {'zip': '390-0821', 'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Kanno Dialysis & Vascular Access Clinic', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '390-1401', 'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Matsumoto City Hospital', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'zip': '386-0405', 'city': 'Ueda', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Maruko Central Hospital', 'geoPoint': {'lat': 36.40265, 'lon': 138.28161}}, {'zip': '573-1195', 'city': 'Hirakata', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Arisawa General Hospital', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'zip': '560-0004', 'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Toyonaka Keijinkai Clinic', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'zip': '348-0045', 'city': 'Hanyū', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Hanyu General Hospital', 'geoPoint': {'lat': 36.16667, 'lon': 139.53333}}, {'zip': '355-0016', 'city': 'Higashi-Matsuyama', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Higashimatsuyamakohjin Clinic', 'geoPoint': {'lat': 36.03333, 'lon': 139.41667}}, {'zip': '343-0823', 'city': 'Koshigaya', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saiyu Clinic', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'zip': '335-0023', 'city': 'Toda', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Todachuo General Hospital', 'geoPoint': {'lat': 35.81447, 'lon': 139.66018}}, {'zip': '192-0082', 'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Hachioji Azumacho Clinic', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'zip': '187-0001', 'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kodaira Kitaguchi Clinic', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'zip': '755-0155', 'city': 'Ube', 'state': 'Yamaguchi', 'country': 'Japan', 'facility': 'Saint Hill Hospital', 'geoPoint': {'lat': 33.94306, 'lon': 131.25111}}, {'zip': '263-0043', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Medical corporation association Shunshin-kai Inage hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '810-0012', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Ikeda Vascular Access Nephrology Dialysis', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '815-0038', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Oohashi internal medicine circulatory Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '861-0135', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Ueki Imafuji Clinic', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '380-0904', 'city': 'Nagano', 'country': 'Japan', 'facility': 'Medical Corporation Suzukihinyoukika', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '850-0032', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki Kidney Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '543-0052', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Akagaki Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '552-0007', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Nishi Shinryosho', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '555-0001', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Chibune Clinic', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '339-0033', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Iwatsuki-minami Hospital', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '990-0834', 'city': 'Yamagata', 'country': 'Japan', 'facility': 'Yamagata Tokushukai Hospital', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}