Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Chronic Kidney Disease
Спонсор: Atom Therapeutics Co., Ltd
Налично на:
БГ
Обобщение
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
Кой може да участва
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
Интервенции
ABP-671 plus febuxostat Group 1
DRUG
ABP-671 plus febuxostat Group 2
DRUG
ABP-671 Group
DRUG
Placebo Group
DRUG
Места на провеждане
9
Австралия (2)
Paratus Clinical Research Brisbane
Brisbane , Queensland
Genesis Research services
Newcastle , New South Wales
Китай (7)
Beijing Tsinghua Changgung Hospital
Beijing , Beijing Municipality
Peking University First Hospital
Beijing , Beijing Municipality
Xuanwu Hospital Capital Medical University
Beijing , Beijing Municipality
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou , Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou , Zhejiang
Jiangsu Province Hospital
Nanjing , Jiangsu
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine