Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuric… (NCT07323095) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Australia, China80 participantsStarted 2026-06-30
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline