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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
Genesis Research services
Newcastle, New South Wales, Australia
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Time frame: Week 28
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Time frame: Week 16
Incidence of treatment-emergent adverse events (Safety and Tolerability)
Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
Time frame: Week 28
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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