Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT03351166
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Molidustat for Correction 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of rise in Hb (Hemoglobin) level (g/dL/week)', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Responder rate: proportion of responders among the subjects', 'timeFrame': 'Week 21 to 24', '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'}], 'secondaryOutcomes': [{'measure': 'Rate of rise in Hb (Hemoglobin) level (g/dL/week)', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Proportion of subjects who meet each component of the response', 'timeFrame': 'Week 21 to 24', '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': 'Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Hb level', 'timeFrame': 'Baseline and up to 24 weeks'}, {'measure': 'Change in Hb level', 'timeFrame': 'Baseline and up to 24 weeks'}, {'measure': 'Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period', 'timeFrame': 'Week 21 to 24'}, {'measure': 'Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period', 'timeFrame': 'Week 21 to 24'}, {'measure': 'Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period', 'timeFrame': 'Week 21 to 24'}, {'measure': 'Proportion of subjects with hemoglobin levels above the target range', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Proportion of subjects with hemoglobin levels below the target range', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Proportion of subjects with hemoglobin levels in the target range', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week', 'timeFrame': 'Up to 24 weeks', 'description': 'Defined as change in Hb level / duration between two visits (weeks)'}, {'measure': 'Number of participants with serious adverse events', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Maximum concentration (Cmax) of Molidustat', 'timeFrame': 'Baseline, Week 8, Week16 and Week 24'}, {'measure': 'Area under the concentration-time curve (AUC) of Molidustat', 'timeFrame': 'Baseline, Week 8, Week16 and Week 24'}, {'measure': 'EPO (Erythropoietin) serum concentration of Molidustat', 'timeFrame': 'Baseline, Week 8, Week16 and Week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia', 'Renal Insufficiency, Chronic']}, 'referencesModule': {'references': [{'pmid': '33506635', 'type': 'DERIVED', 'citation': 'Akizawa T, Nobori K, Matsuda Y, Hayashi Y, Hayasaki T, Yamamoto H. Molidustat for anemia correction in Japanese patients undergoing hemodialysis: a single-arm, phase 3 study. Ther Apher Dial. 2021 Dec;25(6):917-925. doi: 10.1111/1744-9987.13627. Epub 2021 Mar 22.'}, {'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 dialysis subjects with renal anemia who are not 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 end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly\n* Body weight \\> 40 and ≤ 160 kg at screening\n* Male or female subject ≥ 20 years of age at screening\n* At least one kidney\n* Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol\n* Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and \\< 10.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \\< 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment\n* Ferritin ≥ 50 ng/mL 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 and poorly controlled arterial hypertension (defined as systolic BP≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP \\< 90mmHg) at randomization\n* Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)'}, 'identificationModule': {'nctId': 'NCT03351166', 'acronym': 'MIYABI HD-C', 'briefTitle': 'A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)', 'orgStudyIdInfo': {'id': '19351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Molidustat (BAY85-3934)', 'description': 'Molidustat group', 'interventionNames': ['Drug: Molidustat (BAY85-3934)']}], 'interventions': [{'name': 'Molidustat (BAY85-3934)', 'type': 'DRUG', 'description': "Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response", 'armGroupLabels': ['Molidustat (BAY85-3934)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '811-0120', 'city': 'Kasuya-gun', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Houshikai Kano hospital'}, {'zip': '501-6062', 'city': 'Hashima-gun', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Matsunami General Hospital'}, {'zip': '078-8211', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Asahikawa-Kosei General Hospital', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'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': '676-0812', 'city': 'Takasago', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Takasago Seibu Hospital', 'geoPoint': {'lat': 34.76298, 'lon': 134.79229}}, {'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': '986-8522', 'city': 'Ishinomaki', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Japanese Red Cross Ishinomaki Hospital', 'geoPoint': {'lat': 38.41667, 'lon': 141.3}}, {'zip': '395-8505', 'city': 'Iida', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Iida Hospital', 'geoPoint': {'lat': 35.51965, 'lon': 137.82074}}, {'zip': '560-0004', 'city': 'Toyonaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Toyonaka Keijinkai Clinic', 'geoPoint': {'lat': 34.78244, 'lon': 135.46932}}, {'zip': '187-0001', 'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Kodaira Kitaguchi Clinic', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}, {'zip': '263-0043', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Medical corporation association Shunshin-kai Inage hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '810-0004', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka Renal Clinic', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '331-8711', 'city': 'Saitama', 'country': 'Japan', 'facility': 'Ohmiya Chuo General 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'}}}}