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

NCT07323095 · tracked via the Priya Life Science China tracker

Sponsor

Atom Therapeutics Co., Ltd

Phase

Phase 2

Started

2026-06-30

Last updated

2026-06-04

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

ABP-671 plus febuxostat Group 1ABP-671 plus febuxostat Group 2ABP-671 GroupPlacebo Group

ABP-671 plus febuxostat Group 1: ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)

ABP-671 plus febuxostat Group 2: ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)

ABP-671 Group: ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)

Placebo Group: ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline — Week 40

Trial sites (10)

Facility	City	Region
Renal Research Gosford Pty Ltd	Gosford	New South Wales
Genesis Research services	Newcastle	New South Wales
Paratus Clinical Research Brisbane	Brisbane	Queensland
Beijing Tsinghua Changgung Hospital	Beijing	Beijing Municipality
Peking University First Hospital	Beijing	Beijing Municipality
Xuanwu Hospital Capital Medical University	Beijing	Beijing Municipality
Jiangsu Province Hospital	Nanjing	Jiangsu
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang
Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07323095 on ClinicalTrials.gov ↗ ← All trials in China