About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- ABP-671 plus febuxostat Group 1
- ABP-671 plus febuxostat Group 2
- ABP-671 Group
- Placebo Group