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
1 other identifier
interventional
80
2 countries
9
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2026
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedStudy Start
First participant enrolled
June 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
Study Completion
Last participant's last visit for all outcomes
January 31, 2028
April 22, 2026
November 1, 2025
1.3 years
December 8, 2025
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Week 40
Secondary Outcomes (2)
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)
Week 40
Study Arms (4)
ABP-671 plus febuxostat Group 1
ACTIVE COMPARATORInvestigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
ABP-671 plus febuxostat Group 2
ACTIVE COMPARATORInvestigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
ABP-671 Group
EXPERIMENTALInvestigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
Placebo Group
PLACEBO COMPARATORInvestigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
Interventions
ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Genesis Research services
Newcastle, New South Wales, 2019, Australia
Paratus Clinical Research Brisbane
Brisbane, Queensland, Australia
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 100000, China
Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
January 7, 2026
Study Start (Estimated)
June 30, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
April 22, 2026
Record last verified: 2025-11