Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 5:55 PM
Study NCT ID:
NCT03418168
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2018-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Molidustat for Treatment of Renal Anemia in Peritoneal 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': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2018-01-26', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Responder rate: proportion of responders among the subjects', 'timeFrame': 'Week 30 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'}], 'secondaryOutcomes': [{'measure': 'Mean Hb (Hemoglobin) level', 'timeFrame': 'Week 30 to 36'}, {'measure': 'Change in mean Hb level', 'timeFrame': 'Baseline and Week 30 to 36'}, {'measure': 'Rate of rise in Hb (Hemoglobin) level (g/dL/week)', 'timeFrame': 'Up to 8 weeks'}, {'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 30 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': 'Baseline and Up to Week 36'}, {'measure': 'Change in Hb level', 'timeFrame': 'Baseline and Up to Week 36'}, {'measure': 'Proportion of subjects with mean hemoglobin levels are in the target range', 'timeFrame': 'Week 30 to 36'}, {'measure': 'Proportion of subjects with mean hemoglobin levels are above the target range', 'timeFrame': 'Week 30 to 36'}, {'measure': 'Proportion of subjects with mean hemoglobin levels are below the target range', 'timeFrame': 'Week 30 to 36'}, {'measure': 'Proportion of subjects with hemoglobin levels in the target range', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Proportion of subjects with hemoglobin levels above the target range', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Proportion of subjects with hemoglobin levels below the target range', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week', 'timeFrame': 'Up to 36 weeks', 'description': 'Defined as change in Hb level / duration between two visits (weeks)'}, {'measure': 'Percentage of days in the target Hb range during the evaluation period', 'timeFrame': 'Week 30 to 36'}, {'measure': 'Percentage of days in the target Hb range during the treatment period', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Rate of rise in Hb level (g/dL/week) between each consecutive visits', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Percentage of Hb levels in target range during the evaluation period', 'timeFrame': 'Week 30 to 36', 'description': 'Defined as the number of measurements in the target range / number of measurements x 100 \\[%\\])'}, {'measure': 'Percentage of Hb levels in target range during the treatment period', 'timeFrame': 'Up to 36 weeks', 'description': 'Defined as the number of measurements in the target range / number of measurements x 100 \\[%\\])'}, {'measure': 'Proportion of subjects who received at least one rescue treatment', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Proportion of subjects whose Hb level was ≥ 13.0 g/dL or < 8.0 g/dL', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Number of participants with serious adverse events', 'timeFrame': 'Up to 36 weeks'}, {'measure': 'Maximum concentration (Cmax) of Molidustat', 'timeFrame': 'Baseline, Week 8, Wee16 and Week 36'}, {'measure': 'Area under the concentration-time curve (AUC) of Molidustat', 'timeFrame': 'Baseline, Week 8, Wee16 and Week 36'}, {'measure': 'EPO (Erythropoietin) serum concentration of Molidustat', 'timeFrame': 'Baseline, Week 8, Wee16 and Week 36'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia', 'Renal Insufficiency, Chronic']}, 'referencesModule': {'references': [{'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 peritoneal dialysis subjects with renal anemia'}, '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 peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period\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* Subjects who meet one of the 1 or 2 following criteria\n\n * Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 8.0 and \\< 11.0 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 * Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and \\< 13.0 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* Subjects who meet one of the 1 or 2 following criteria\n\n * Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol\n * Subjects pre treated with ESA at assignment:\n\n * Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment\n * Subject treated with ESA by IV or SC within 8 weeks prior to assignment\n * Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment\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': 'NCT03418168', 'acronym': 'MIYABI PD', 'briefTitle': 'A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia', 'orgStudyIdInfo': {'id': '19353'}}, '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': '498-8502', 'city': 'Yatomi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Kainan Hospital', 'geoPoint': {'lat': 35.1053, 'lon': 136.73378}}, {'zip': '790-0024', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Ehime Prefectural Central Hospital', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '802-8555', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kokura Memorial Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '806-8501', 'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'JCHO Kyushu Hospital', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'zip': '830-0011', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '003-0814', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Elm Grove Clinic', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '650-0047', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe City Medical Center General Hospital', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '251-8550', 'city': 'Fujisawa', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Fujisawa City Hospital', 'geoPoint': {'lat': 35.34926, 'lon': 139.47666}}, {'zip': '247-8533', 'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '213-8587', 'city': 'Kawasaki', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Toranomon Hospital Kajigaya', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '227-8501', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Showa University Fujigaoka Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '983-8512', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku Medical and Pharmaceutical University Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '957-8588', 'city': 'Shibata', 'state': 'Niigata', 'country': 'Japan', 'facility': 'Niigata Prefectural Shibata Hospital', 'geoPoint': {'lat': 37.95, 'lon': 139.33333}}, {'zip': '874-0011', 'city': 'Beppu', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'National Hospital Organization Beppu Medical Center', 'geoPoint': {'lat': 33.27945, 'lon': 131.49751}}, {'zip': '904-2293', 'city': 'Uruma', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'Okinawa prefectural Chubu Hospital', 'geoPoint': {'lat': 26.37609, 'lon': 127.85908}}, {'zip': '594-0076', 'city': 'Izumi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Fuchu Hospital', 'geoPoint': {'lat': 34.48333, 'lon': 135.43333}}, {'zip': '918-8503', 'city': 'Fukui', 'country': 'Japan', 'facility': 'Fukui-ken Saiseikai Hospital', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'zip': '812-8582', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '814-0180', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Fukuoka University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '815-8555', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Japanese Red Cross Fukuoka Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '960-1295', 'city': 'Fukushima', 'country': 'Japan', 'facility': 'Fukushima Medical University Hospital', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'zip': '500-8523', 'city': 'Gifu', 'country': 'Japan', 'facility': 'Asahi University Hospital', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '612-8555', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'National Hospital Organization Kyoto Medical Center', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '630-8581', 'city': 'Nara', 'country': 'Japan', 'facility': 'Nara Prefecture General Medical Center', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'zip': '950-1197', 'city': 'Niigata', 'country': 'Japan', 'facility': 'Niigata City General Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '558-8558', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka General Medical Center', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '870-0033', 'city': 'Ōita', 'country': 'Japan', 'facility': 'Japanese Red Cross Oita Hospital', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}