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Recruiting NCT07323095

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

Conditions: Chronic Kidney Disease

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: Atom Therapeutics Co., Ltd

Location: Renal Research Gosford Pty Ltd Gosford New South Wales

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07323095). StuddyBuddy aggregates publicly available trial information.