Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABP-671 plus febuxostat Group 1, ABP-671 plus febuxostat Group 2, ABP-671 Group, Placebo Group.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
Interventions
- Drug ABP-671 plus febuxostat Group 1
ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO) - Drug ABP-671 plus febuxostat Group 2
ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO) - Drug ABP-671 Group
ABP-671 Dose 2 + Febuxostat placebo-tablets(PO) - Drug Placebo Group
ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)
Primary outcome measures
- 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 outcome measures (2)
- 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]
- Incidence of treatment-emergent adverse events (Safety and Tolerability) [Time frame: Week 40]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Beijing Tsinghua Changgung Hospital — Beijing
- Peking University First Hospital — Beijing
- Xuanwu Hospital Capital Medical University — Beijing
- Jiangsu Province Hospital — Nanjing
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai
- Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Hangzhou
- Zhejiang Provincial People's Hospital — Hangzhou
Australia · 3 centers
- Renal Research Gosford Pty Ltd — Gosford
- Genesis Research services — Newcastle
- Paratus Clinical Research Brisbane — Brisbane
Identifiers
NCT: NCT07323095 · ABP-671-202