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

A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: ABP-671 plus febuxostat Group 1; Drug: ABP-671 plus febuxostat Group 2; Drug: ABP-671 Group; Drug: Placebo Group

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Renbo Gao; Phone Number: +86 15062305252; Email: renbo.gao@atombp.com

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia, 2019
      • Genesis Research Services
  • Queensland
    • Brisbane, Queensland, Australia
      • Paratus Clinical Research Brisbane
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Peking University First Hospital
    • Beijing, Beijing Municipality, China, 100000
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing Municipality, China, 100000
      • Xuanwu Hospital Capital Medical University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Jiangsu Province Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310000
      • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ABP-671 plus febuxostat Group 1; Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice	Drug: ABP-671 plus febuxostat Group 1; ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
Active Comparator: ABP-671 plus febuxostat Group 2; Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice	Drug: ABP-671 plus febuxostat Group 2; ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
Experimental: ABP-671 Group; Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice	Drug: ABP-671 Group; ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
Placebo Comparator: Placebo Group; Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice	Drug: Placebo Group; ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline		Week 16
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	Week 40

Collaborators and Investigators

• Sponsor: Atom Therapeutics Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: ABP-671-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No