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Предстои набиране Фаза 2 NCT07323095

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
Shanghai , Shanghai Municipality
Технически детайли
Статус
Предстои набиране
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
30.06.2026
Крайна дата
31.01.2028
Регистрационен номер
NCT07323095
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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