Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:52 AM
Study NCT ID:
NCT07323095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline', 'timeFrame': 'Week 28'}], 'secondaryOutcomes': [{'measure': 'The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline', 'timeFrame': 'Week 16'}, {'measure': 'Incidence of treatment-emergent adverse events (Safety and Tolerability)', 'timeFrame': 'Week 28', 'description': 'Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This is a phase 2, international, multicenter, randomized, double blind, parallel group trial to evaluate the efficacy and safety of ABP-671 in subjects with CKD and hyperuricaemia, to preliminarily evaluate the efficacy of ABP-671 in the treatment of subjects with CKD and hyperuricemia, primary Efficacy Endpoint is change in UACR from baseline to Week 28'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18-75 years , who voluntarily participate in this clinical trial, understand and comply with the procedures stipulated in this study\n* Patients who have been diagnosed with CKD based on Clinical Practice Guideline\n* During screening, body mass index (BMI) was ≥18.0 and ≤ 40.0 kg/m2\n* The sUA levels \\> 420 μmol/L (7.0 mg/dL)\n\nExclusion Criteria:\n\n* History of renal transplantation\n* The 24-hour urinary protein ≥ 3.5 g/day\n* Liver function abnormality: aspartate aminotransferase or alanine aminotransferase, or alkaline phosphatase \\> 3 times the upper limit of normal value (ULN)\n* Subjects with mental disorders who are unable to communicate normally with the investigator\n* Subjects who have participated in another clinical study during the screening period are within 30 days of the last dose of the study drug in another study\n* The investigator judged that the subject was not suitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT07323095', 'briefTitle': 'Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atom Therapeutics Co., Ltd'}, 'officialTitle': 'A Phase 2, International, Multicenter, Randomized, Double-blind, Parallel-group Trial to Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia', 'orgStudyIdInfo': {'id': 'ABP-671-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ABP-671 plus febuxostat Group 1', 'description': "Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice", 'interventionNames': ['Drug: ABP-671 plus febuxostat Group 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ABP-671 plus febuxostat Group 2', 'description': "Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice", 'interventionNames': ['Drug: ABP-671 plus febuxostat Group 2']}, {'type': 'EXPERIMENTAL', 'label': 'ABP-671 Group', 'description': "Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice", 'interventionNames': ['Drug: ABP-671 Group']}], 'interventions': [{'name': 'ABP-671 plus febuxostat Group 1', 'type': 'DRUG', 'description': 'ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)', 'armGroupLabels': ['ABP-671 plus febuxostat Group 1']}, {'name': 'ABP-671 plus febuxostat Group 2', 'type': 'DRUG', 'description': 'ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)', 'armGroupLabels': ['ABP-671 plus febuxostat Group 2']}, {'name': 'ABP-671 Group', 'type': 'DRUG', 'description': 'ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)', 'armGroupLabels': ['ABP-671 Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2019', 'city': 'Newcastle', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Genesis Research services', 'geoPoint': {'lat': -32.92953, 'lon': 151.7801}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tsinghua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Renbo Gao', 'role': 'CONTACT', 'email': 'renbo.gao@atombp.com', 'phone': '+86 15062305252'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atom Therapeutics Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}