Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia

Официальное название

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

Обзор

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

Вмешательства

• Препарат ABP-671 plus febuxostat Group 1
  ABP-671 Dose 1 + Febuxostat Dose 1-tablets(PO)
• Препарат ABP-671 plus febuxostat Group 2
  ABP-671 Dose 2 + Febuxostat Dose 2-tablets(PO)
• Препарат ABP-671 Group
  ABP-671 Dose 2 + Febuxostat placebo-tablets(PO)
• Препарат Placebo Group
  ABP-671 placebo-tablets(PO) + Febuxostat placebo-tablets(PO)

Первичные конечные точки

• The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline [Срок оценки: Week 40]

Вторичные конечные точки (2)

• The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline [Срок оценки: Week 16]
• Incidence of treatment-emergent adverse events (Safety and Tolerability) [Срок оценки: Week 40]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Beijing Tsinghua Changgung Hospital — Пекин
• Peking University First Hospital — Пекин
• Xuanwu Hospital Capital Medical University — Пекин
• Jiangsu Province Hospital — Нанкин
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
• Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine — Ханчжоу
• Zhejiang Provincial People's Hospital — Ханчжоу

Австралия · 3 центра

• Renal Research Gosford Pty Ltd — Gosford
• Genesis Research services — Newcastle
• Paratus Clinical Research Brisbane — Brisbane

Идентификаторы

NCT: NCT07323095 · ABP-671-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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