ABP-671 in people with chronic kidney disease and high uric acid

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, international, multicenter, randomized, double-blind, placebo-controlled study designed to test the efficacy and safety of ABP-671 in adults with chronic kidney disease and hyperuricaemia. Participants are randomized to receive ABP-671 alone, ABP-671 with febuxostat, or placebo, with two groups also receiving febuxostat in combination. The primary efficacy endpoint is the change in the urinary albumin-to-creatinine ratio (UACR) from baseline to Week 40, providing an early look at kidney-related benefits. Safety monitoring and interim assessments are included to characterize tolerability in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Genesis Research services
  Newcastle, New South Wales, Australia Recruiting
• Paratus Clinical Research Brisbane
  Brisbane, Queensland, Australia Recruiting
• Renal Research Gosford Pty Ltd
  Gosford, New South Wales, Australia Not yet recruiting
• Beijing Tsinghua Changgung Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University First Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Xuanwu Hospital Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Renbo Gao
• Email: renbo.gao@atombp.com
• Phone: +86 15062305252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.