jRCTs061210079已完成不适用
Assessment of efficacy and safety of dotinurad therapy for hyperuricemic patients with kidney dysfunction (DTN-CKD study)
未提供0 个研究点目标入组 100 人开始时间: 2022年3月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with hyperuricemia aged 20 years or older at the time of providing informed consent
- •Patients who have not received treatment with uricosuric drugs within 2 weeks prior to the observation start date
- •Patients with a serum uric acid level (untreated level) 8.0 mg/dL or higher within 6 weeks prior to the observation start date
- •Patients with an estimated GFR (eGFR) 15 mL/min/1.73m2 or higher within 6 weeks prior to the observation start date
排除标准
- •Patients with acute gouty arthritis that has not subsided
- •Patients diagnosed with urolithiasis
- •Patients with secondary hyperuricemia (tumor lysis syndrome, etc.)
- •Patients with an AST or ALT of 100 IU/L or higher
- •Patients who are pregnant, likely to be pregnant, or breastfeeding
- •Patients with a history of hypersensitivity to the ingredients contained in dotinurad preparations
- •Patients who are judged as inappropriate for this study by the principal investigator or subinvestigator
结局指标
主要结局
-
Percent change in serum uric acid levels at 24 weeks in G1/G2 and G3/G4 groups (non-inferiority)
次要结局
- Change and percent change in serum uric acid levels and proportion of patients reaching the target level at 4, 8, 12, 24 weeks in G1/G2 and G3/G4 groups(4, 8, 12, 24 weeks)
- Change and percent change in eGFR at 24 weeks in G1/G2 and G3/G4 groups(24 weeks)
- Change and percent change in serum uric acid levels and proportion of patients reaching the target level at 4, 8, 12, 24 weeks in eGFR classification-based 5 subgroups(4, 8, 12, 24 weeks)
- Change and percent change in eGFR at 24 weeks in eGFR classification-based 5 subgroups(24 weeks)
- Change and percent change in serum uric acid levels by dose and proportion of patients reaching the target level
- Change and percent change in serum uric acid levels by presence/absence and by cause of renal dysfunction and proportion of patients reaching the target level
- Change and percent change in serum uric acid levels by age and proportion of patients reaching the target level
- Dynamics of uric acid clearance/creatinine clearance ratio (CUA/CCr)
- Dynamics of urine protein/creatinine ratio and urine albumin/creatinine ratio
- Adverse events
- Liver function test results (AST, ALT, gamma-GT)
- Urinary pH
- Casual blood glucose level, HbA1c
- Investigation on the differences in patient backgrounds (at week 0) between patients who have reached the target level of serum uric acid control and those who have not(week 0)
- Investigation on the differences in information during the observation period, such as the dose of dotinurad and the incidence of gout, between patients who have reached the target level of serum uric acid control and those who have not(observation period)
研究者
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