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NCT Number: NCT07323095

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

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Renal Research Gosford Pty Ltd, Gosford, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABP-671 plus febuxostat Group 1

Drug

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

ABP-671 plus febuxostat Group 2

Drug

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

ABP-671 Group

Drug

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

Placebo Group

Drug

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

Primary outcomes

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

    Time frame: Week 40

Secondary outcomes

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

    Time frame: Week 16

  2. Incidence of treatment-emergent adverse events (Safety and Tolerability)

    Time frame: Week 40

    Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation

Study contacts

Contact information is provided by the study sponsor or research team.

Renbo Gao

CONTACT

[email protected]

+86 15062305252

Sponsors and collaborators

Lead sponsor

Atom Therapeutics Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 7, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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