Efficacy, Safety and Response Predictors of Adjuvant Astragalus Therapy for Diabetic Kidney Disease (READY) - An Open-label Randomised Controlled Trial With Responder Regression Analysis
试验速览
- 阶段
- 2 期
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in estimated GFR
研究概览
简要总结
This add-on open-label randomised controlled pragmatic trial aims to:
- evaluate the effect of add-on astragalus treatment on type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria.
- estimate treatment effect, variance, recruitment rate, attrition rate and change in clinical manifestation including Chinese medicine syndrome for parameters optimisation and feasibility assessment for a subsequent phase III randomised controlled trial.
- assess response predictors for efficacy and safety among type 2 diabetic patients with stage 2 to 3 chronic kidney disease and macroalbuminuria receiving add-on astragalus treatment
详细描述
This add-on open-label randomised controlled pragmatic trial.
Sample size is calculated based on planned regression analysis. We believe an annual GFR benefit of 5 ml/min/1.73m2 is deemed significant clinically. 118 patients are therefore needed to offer a power of 70% to detect a GFR difference of 5 ml/min/1.73m2 over 48-week allowing 15% attrition rate for this study with a significance level of alpha equals to 0.05.
A trial management committee (TMC) formed by PA, Co-As and RA will centralise all the data of the trial. Co-As and RA will collect, clean and send the data of patients to TMC on a weekly basis. All data will be double entered to computer and cleaned before analysis to prevent data entry errors. All data transfer will be encrypted to protect patients' confidentiality. TMC will have regular meetings monthly with experts to discuss the progress of the trial. An independent Data Monitoring Board (DMB) will be invited to monitor the progress of the trial. DMB will advise ethics committee to terminate the trial if data is showing extreme benefits or harm. Detailed guidelines will be discussed and set by DMB.
Missing values will be imputed with last observation carried forward. Patient without a postrandomisation assessment for a particular efficacy endpoint will be excluded from the analysis of that endpoint.
Regression analysis will be used to compare the adjusted mean of eGFR, UACR, HbA1c, FBG, and other biomarkers at week 48 between groups and statistical significance. The adverse events will be analysed in a narrative manner. The percentage of all adverse events and the rate of attrition due to adverse events will be compared between intervention groups and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessment of primary outcomes is performed by an independent laboratory
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with type 2 diabetes for at least 5 years;
- •with an estimated glomerular filtration rate (GFR) ≥30 ˂90 mL/min/1.73m2 confirmed with repeat testing over three or more months calculated by the abbreviated MDRD study equation;
- •persistent macroalbuminuria with spot urine albumin-to-creatinine ratio (UACR) ≥ 300 mg/g confirmed by at least 2 out of 3 consecutive first morning void urine samples;
- •on stable dose of anti-diabetic drug including insulin for 12 weeks;
- •on stable dose of angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker for 12 weeks; and
- •willing and able to give written informed consent
排除标准
- •with known history of glomerulonephritis, polycystic kidney disease, systemic lupus erythematosus, any suggestive evidence of nondiabetic glomerulopathy;
- •with known history of kidney transplant;
- •with concurrent severe disorders of heart, brain, liver, and hematopoietic system, tumor and mental disorder;
- •with deranged liver function;
- •poorly controlled blood pressure;
- •with known history of intolerance or malabsorption of oral medications;
- •with uncontrollable urinary infection;
- •experiencing pregnancy; or
- •participating in other clinical trial within 30 days
研究组 & 干预措施
Standard medical care
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker and oral hypoglycemic agents or insulin
干预措施: Routine medical care (active comparator) (Other)
Add on astragalus powder
3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks.
干预措施: Astragalus Powder (Drug)
Add on astragalus powder
3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks.
干预措施: Routine medical care (active comparator) (Other)
结局指标
主要结局
Change in estimated GFR
时间窗: From baseline to 48 weeks after treatment
Efficacy and safety
Change in spot urine albumin-to-creatinine ratio
时间窗: From baseline to 48 weeks after treatment
Efficacy and safety
次要结局
- Change in glycated haemoglobin (HbA1c)(From baseline to 48 weeks after treatment)
- Change in urinary Cystatin C(From baseline to 48 weeks after treatment)
- Change in lipids(From baseline to 48 weeks after treatment)
- Change in urinary monocyte chemotactic protein 1 (MCP-1)(From baseline to 48 weeks after treatment)
研究者
Sydney CW TANG
Chair of Renal Medicine and Yu Professor in Nephrology
The University of Hong Kong