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

NCT ID: NCT07323095

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2028-01-31

Brief Summary

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This is a phase 2, international, multicenter, randomized, double blind, parallel group 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 28

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

ABP-671 plus febuxostat Group 1

Intervention Type DRUG

ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)

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

Group Type ACTIVE_COMPARATOR

ABP-671 plus febuxostat Group 2

Intervention Type DRUG

ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)

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

Group Type EXPERIMENTAL

ABP-671 Group

Intervention Type DRUG

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

Interventions

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ABP-671 plus febuxostat Group 1

ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)

Intervention Type DRUG

ABP-671 plus febuxostat Group 2

ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)

Intervention Type DRUG

ABP-671 Group

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atom Therapeutics Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Genesis Research services

Newcastle, New South Wales, Australia

Site Status

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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Australia China

Central Contacts

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Renbo Gao

Role: CONTACT

+86 15062305252

Other Identifiers

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ABP-671-202

Identifier Type: -

Identifier Source: org_study_id

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