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
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)
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
Parallel
ABP-671 plus febuxostat Group 1
DrugABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
ABP-671 plus febuxostat Group 2
DrugABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
ABP-671 Group
DrugABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
Placebo Group
DrugABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
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
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
