Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-01-27 @ 3:42 AM
Study NCT ID:
NCT06434961
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2024-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Trial of SHR6508 in Secondary Hyperparathyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-05-24', 'studyFirstSubmitQcDate': '2024-05-24', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline', 'timeFrame': 'efficacy assessment period, defined as Week 20-27', 'description': 'iPTH was tested at a central laboratory.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline', 'timeFrame': 'efficacy assessment period, defined as Week 20-27', 'description': 'iPTH was tested at a central laboratory.'}, {'measure': 'Incidence of nausea and vomiting events', 'timeFrame': 'Day1 to End of Treatment, End of Treatment is about Week 27', 'description': 'Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)'}, {'measure': 'Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline', 'timeFrame': 'efficacy assessment period, defined as Week 20-27', 'description': 'iPTH was tested at a central laboratory.'}, {'measure': 'Change From Baseline in serum cCa and P', 'timeFrame': 'efficacy assessment period, defined as Week 20-27', 'description': 'cCa and P were tested at a central laboratory.'}, {'measure': 'Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Day1 to End of Study, End of Study is about Week 31', 'description': 'Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)'}, {'measure': 'Participants with Anti-SHR6508 Antibody at baseline and postbaseline', 'timeFrame': 'Day1 to End of Study, End of Study is about Week 31', 'description': 'Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Diagnosed with end stage renal disease receiving maintenance hemodialysis\n3. Male or female\n4. Meet the Body Mass Index standard\n5. Stably use of concomitant medication of other therapies of SHPT\n6. Meet the standard of iPTH level, cCa\n\nExclusion Criteria:\n\n1. Subjects with a history of malignant tumor\n2. Subjects with neuropsychiatric diseases\n3. Subjects with a history of cardiovascular diseases\n4. Subjects with gastrointestinal diseases\n5. Subjects with a history of surgery\n6. Subjects with a history of blood loss\n7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin\n8. Subjects with a treatment history of similar drugs\n9. Allergic to a drug ingredient or component\n10. Pregnant or nursing women\n11. No birth control during the specified period of time\n12. Subject with a history of alcohol abuse and drug abuse\n13. Participated in clinical trials of other drugs\n14. The investigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT06434961', 'briefTitle': 'The Trial of SHR6508 in Secondary Hyperparathyroidism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism', 'orgStudyIdInfo': {'id': 'SHR6508-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'interventionNames': ['Drug: SHR6508 plus oral placebo tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control group', 'interventionNames': ['Drug: Cinacalcet plus intravenous placebo']}], 'interventions': [{'name': 'SHR6508 plus oral placebo tablets', 'type': 'DRUG', 'description': 'SHR6508 plus oral placebo tablets', 'armGroupLabels': ['Treatment group']}, {'name': 'Cinacalcet plus intravenous placebo', 'type': 'DRUG', 'description': 'Cinacalcet plus intravenous placebo', 'armGroupLabels': ['Active Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}