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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAtom Therapeutics Co., Ltd

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

Treatment groups

80 Participants
are divided into 4 treatment groups

Sponsors and collaborators