Effectiveness of Chinese Medicine on Deferring Dialysis Initiation for Stage 5 Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 875
- 试验地点
- 29
- 主要终点
- Time to initiation of dialysis from enrollment.
研究概览
简要总结
Stage 5 chronic kidney disease (CKD), also end stage renal disease(ESRD), usually presents overt clinical symptoms and is a critical stage when patients are encountered with dialysis. The optimal time to initiating dialysis in patients with stage 5 CKD is addressed as the most important dialysis-related question. As indicated by the recently published European Renal Best Practice (ERBP) guideline, early initiation seemed to produce no benefit but greater expenditure and sometimes more harm.Renal replacement therapies (RRT) including dialysis are the most common procedures for patients with end-stage renal disease (ESRD), but conservative management should be an option in patients who still experience the stable period without clinical indications of dialysis.Chinese Medicine (CM) is recognized as an alternative therapy on alleviating uremic symptoms, deferring dialysis initiation, and improving quality of life. Although the effects of CM on kidney disease have been demonstrated in animal experiments, evidence from large clinical trial is insufficient. So we raise the hypothesis that CM therapies including Chinese herbal formula, Chinese patent medicine via oral pattern and/or Colonic administration, will defer the initiation of dialysis in adults with stage 5 CKD.
详细描述
Chinese Medicine (CM) treatment has been applied to CKD patients commonly in China, especially those independent of dialysis. Based on the personal experience of experts from different areas in China, patients with stage 5 CKD have been treated with different formulations of herbs including Astragalus membranaceus (Huangqi), Codonopsis pilosula (Dangshen), Semen Cuscutae (Tusizi) and Radix et Rhizoma Rhei (Dahuang) etc. . Based on the Traditional Chinese Medicine theory and clinical practise, these herbal medicines help strengthening "spleen-kidney" and dispelling "turbidity" . To determine whether CM therapies including Chinese herbal formula, Chinese patent medicine via oral pattern and/or Colonic administration, will significantly defer dialysis initiation, we conduct the Chinese Medicine on Deferring Dialysis Initiation (C-MODDI) study. It's a multicenter, prospective, controlled trial, also an effectiveness study that are conducted in the "real world" of a variety of busy clinical practices, with heterogeneous interventions that are more representative of the general effectiveness of CM therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years;
- •with an estimated glomerular filtration rate (eGFR) between 5.5-15 ml/min per 1.73 m2;
- •Non-diabetic CKD, which should be identified by biopsy or patients' medical histories.
- •East Asian.
排除标准
- •Clinical indications of dialysis still occur after conservative kidney management for 1 week, which will be ruled out as hemoglobin < 70g/L; or serum potassium> 6.5mmol/L; or Carbon Dioxide Combining Power (CO2CP) <13mmol/L; or EPI-GFR≤5ml/min/1.73m2 ;
- •Pregnant or lactating.
- •Critical status, such as alimentary tract hemorrhage or decompensated cirrhosis;
- •History of malignancy other than a successfully and completely treated carcinoma;
- •Any condition (mental or physical) that would interfere with the patient's ability to comply with the study protocol;
- •Concurrent or current treatment with glucocorticoid or immunosuppressant agents in last 3 months;
- •Participation in any other clinical trial;
- •Known or suspected allergy to certain agents involved;
研究组 & 干预措施
CKD-related management group
Patients in basic care group are provided with basic western medicine treatment according to Kidney Disease: Improving Global Outcomes(KDIGO) and The National Kidney Foundation Kidney Disease Outcomes Quality Initiative(KDOQI) guidelines but not prescribed any Chinese herbal medicine.
The basic western medicine treatment mainly includes dietary protein restriction(0.6g/kg·d, for Chinese), Blood pressure control, treating anemia with erythropoietin,treatment of abnormal calcium-phosphate metabolism, and treatment of fluid, electrolyte and acid-base disorders.
干预措施: CKD-related management (Drug)
CM therapies group
Participants will receive CM therapies and CKD-related management concurrently. One or several the following CM patterns will be allowed: a. Chinese herbal formula via oral administration; b. Chinese patent medicine via oral administration; c. Chinese herbal formula via colonic administration; d. Chinese patent medicine via colonic administration.
干预措施: CM therapies (Drug)
CM therapies group
Participants will receive CM therapies and CKD-related management concurrently. One or several the following CM patterns will be allowed: a. Chinese herbal formula via oral administration; b. Chinese patent medicine via oral administration; c. Chinese herbal formula via colonic administration; d. Chinese patent medicine via colonic administration.
干预措施: CKD-related management (Drug)
结局指标
主要结局
Time to initiation of dialysis from enrollment.
时间窗: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Averaged time from enrollment to dialysis initiation or death from any cause, whichever comes first. Patients commence dialysis based on the following criteria: 1. Clinical indications of dialysis include medically refractory serum potassium\> 6.5mmol/L, total carbon dioxide (TCO2) \<13mmol/L, eGFR≤5ml/min/1.73m2 (calculated by EPI formula), or the patient is symptomatic (see criteria #2). If these indications remain occur after receiving conservative CKD-related management for 1 week, or if relapse twice within one month, the patient definitely reaches the endpoint. 2. Uremic symptoms include nausea, vomit, malnutrition, pericarditis or pleurisy, volume overload, encephalopathy, bleeding tendency, refractory hypertension, or other symptoms that are likely to be ameliorated by dialysis.
次要结局
- Cardio-cerebro vascular events(From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.)
- incidence of severe adverse event/reaction(From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.)
- Slope of reciprocal serum creatinine(From date of enrollment until the date of first dialysis or date of death from any cause,or the end of study, whichever come first.The duration of follow up will be for a maximum of 4 years.)
- Nutrition and microinflammation status(From date of enrollment until the date of death from any cause,or the end of study, whichever come first, performed every 6 months.The duration of follow up will be for a maximum of 4 years.)
- all-cause mortality(From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.)
- Hospitalization or death caused by severe infection.(From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.)
研究者
Liu Xu-sheng
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine