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
| Registry | NCT07323095 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Atom Therapeutics Co., Ltd (Industry) |
| Conditions | Chronic Kidney Disease |
| Interventions | ABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2, ABP-671 Group, Placebo Group (Drug) |
| Dates | start 2026-06-30 (estimated), primary completion 2027-10-31 (estimated), completion 2028-01-31 (estimated), first posted 2026-01-07, last updated 2026-06-04 |
| Locations | 10 sites in Australia, China |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Kidney Disease All trials of ABP-671 plus febuxostat Group 1 All trials of ABP-671 plus febuxostat Group 2
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ABP-671 plus febuxostat Group 1 | Active comparator | Drug: 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 |
| ABP-671 plus febuxostat Group 2 | Active comparator | Drug: 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 |
| ABP-671 Group | Experimental | Drug: 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 |
| Placebo Group | Placebo comparator | Drug: Placebo 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 |
Sex: All, ages: 18 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Renal Research Gosford Pty Ltd | Gosford, New South Wales | Australia | |
| Genesis Research services | Newcastle, New South Wales | Australia | |
| Paratus Clinical Research Brisbane | Brisbane, Queensland | Australia | |
| Beijing Tsinghua Changgung Hospital | Beijing, Beijing Municipality | China | |
| Peking University First Hospital | Beijing, Beijing Municipality | China | |
| Xuanwu Hospital Capital Medical University | Beijing, Beijing Municipality | China | |
| Jiangsu Province Hospital | Nanjing, Jiangsu | China | |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai Municipality | China | |
| Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine | Hangzhou, Zhejiang | China | |
| Zhejiang Provincial People's Hospital | Hangzhou, Zhejiang | China |