Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
NCT ID: NCT07323095
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2026-02-01
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABP-671 plus febuxostat Group 1
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
ABP-671 plus febuxostat Group 1
ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
ABP-671 plus febuxostat Group 2
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
ABP-671 plus febuxostat Group 2
ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
ABP-671 Group
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
ABP-671 Group
ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
Interventions
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ABP-671 plus febuxostat Group 1
ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
ABP-671 plus febuxostat Group 2
ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
ABP-671 Group
ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
Eligibility Criteria
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Inclusion Criteria
* Patients who have been diagnosed with CKD based on Clinical Practice Guideline
* During screening, body mass index (BMI) was ≥18.0 and ≤ 40.0 kg/m2
* The sUA levels \> 420 μmol/L (7.0 mg/dL)
Exclusion Criteria
* The 24-hour urinary protein ≥ 3.5 g/day
* Liver function abnormality: aspartate aminotransferase or alanine aminotransferase, or alkaline phosphatase \> 3 times the upper limit of normal value (ULN)
* Subjects with mental disorders who are unable to communicate normally with the investigator
* 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
* The investigator judged that the subject was not suitable for participation in this study
18 Years
75 Years
ALL
No
Sponsors
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Atom Therapeutics Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Genesis Research services
Newcastle, New South Wales, Australia
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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ABP-671-202
Identifier Type: -
Identifier Source: org_study_id
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