Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-04-02 @ 3:33 AM
Study NCT ID:
NCT02133404
Status:
COMPLETED
Last Update Posted:
2024-11-06
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'C000628269', 'term': 'ASP7991'}, {'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum iPTH concentration', 'timeFrame': 'Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment', 'description': 'iPTH: intact parathyroid hormone'}], 'secondaryOutcomes': [{'measure': 'Corrected serum Ca, Phosphate(P) concentration', 'timeFrame': 'Before and at 3, 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment', 'description': 'Ca x P will be calculated'}, {'measure': 'serum vitamin D concentration', 'timeFrame': 'Before and at 22, 43, 64, 85 and 92 days after start of the treatment'}, {'measure': 'serum wPTH concentration', 'timeFrame': 'Before and at 22, 43, 64, 85 and 92 days after start of the treatment', 'description': 'wPTH: whole parathyroid hormone'}, {'measure': 'Serum concentration of bone metabolism markers', 'timeFrame': 'Before and at 22, 43, 64, 85 and 92 days after start of the treatment', 'description': 'Bone metabolism markers will be BAP (Bone specific alkaline phosphatase) and TRACP5b (Tartrate-resistant acid phosphatase-5b)'}, {'measure': 'Serum FGF23 concentration', 'timeFrame': 'Before and at 22, 43, 64, 85 and 92 days after start of the treatment'}, {'measure': 'Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs', 'timeFrame': 'For 12 weeks after start of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mineral bone disease(MBD)', 'Chronic kidney disease(CKD)', 'secondary hyperparathyroidism(SHPT)'], 'conditions': ['Secondary Hyperparathyroidism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=277', 'label': 'Link to results on the Astellas Clinical Study Results Web site'}]}, 'descriptionModule': {'briefSummary': 'To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis', 'detailedDescription': 'This study is a multicenter, double-blind, randomized, Cinacalcet hydrochloride-controlled, parallel-group, dose-ascending study. Subjects judged to be eligible will be registered and randomized into either ASP7991 group (receiving ASP7991 and cinacalcet-placebo) or Cinacalcet group (receiving cinacalcet and ASP7991-placebo), and will receive 12-week (84 days) administration of study drug from first dialysis day in a week (treatment period), in a double-blind manner. The dose of the study drugs will be increased every 3 weeks in dose-ascending manner.\n\nFollow-up assessment will be performed before starting first dialysis in a week, 1 week (7 days) after the completion of the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period\n* Patients with secondary hyperparathyroidism\n* Patients whose serum iPTH concentration is \\>240 pg/mL and corrected serum Ca is ≥ 9.0 mg/dL\n* Patients who have had no changes in the following items ≥4-week (28 days).\n\n * Dosage and regimen, including new administration, of active vitamin D, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods)\n * Ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week\n\nExclusion Criteria:\n\n* Patients who underwent parathyroid intervention, such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT), within 24 weeks (168 days) prior to the administration\n* Patients who have primary hyperparathyroidism\n* Patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days)\n* Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are observed at \\>2/3 of all confirmable measurements\n* Patients who are complicated by severe heart disorder \\[congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction\\], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks (84 days) before administration of the study drug\n* Patients with hepatic function abnormal (ALT or AST is \\>2× ULN, or total bilirubin (T-bil) is \\> 1.5 × ULN.)\n* Patients with a history of malignant tumor or the patient's condition is complicated by malignant tumor. (However, enrollment is acceptable if the tumor has not relapsed for 5 years or longer.)\n* Patients with a history of serious drug allergy including anaphylactic shock\n* Patients with a history of drug allergy to Cinacalcet hydrochloride\n* Female patients who are potentially child-bearing or lactating, or patients who do not comply with the instructed contraceptive measures\n* Patients who were or are currently involved in trials for other investigational drugs or medical devices, or clinical trial for post-marketing study drugs within 12 weeks (84 days) before the study\n* Patients who have received ASP7991 in the past\n* Patients who were judged ineligible to participate in the study by the\n\ninvestigator / subinvestigator"}, 'identificationModule': {'nctId': 'NCT02133404', 'briefTitle': 'A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase II Study of ASP7991 -A Double-blind, Cinacalcet Hydrochloride-controlled, Dose-ascending Study in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis -', 'orgStudyIdInfo': {'id': '7991-CL-1004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP7991 group', 'description': 'receiving ASP7991 and Cinacalcet-placebo', 'interventionNames': ['Drug: ASP7991', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cinacalcet group', 'description': 'receiving Cinacalcet and ASP7991-placebo', 'interventionNames': ['Drug: Cinacalcet', 'Drug: Placebo']}], 'interventions': [{'name': 'ASP7991', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['ASP7991 group']}, {'name': 'Cinacalcet', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Cinacalcet group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['ASP7991 group', 'Cinacalcet group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Kanto', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}, {'city': 'Shikoku', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}