Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia

A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia

This is a phase 2, international, multicenter, randomized, double blind, placebo-controlled 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 40

Inclusion Criteria:

• Male or female aged 18-75 years , who voluntarily participate in this clinical trial, understand and comply with the procedures stipulated in this study
• 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:

• History of renal transplantation
• 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