Chinese Medicine on Deferring Dialysis Initiation
- Conditions
- End-Stage Renal Disease
- Interventions
- Drug: CKD-related managementDrug: CM therapies
- Registration Number
- NCT02194946
- Lead Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 875
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKD-related management group CKD-related management 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. CM therapies group CM therapies 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. CM therapies group CKD-related management 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.
- Primary Outcome Measures
Name Time Method Time to initiation of dialysis from enrollment. 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.
- Secondary Outcome Measures
Name Time Method Cardio-cerebro vascular events From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years. Cardio-cerebro vascular events, i.e. cerebral hemorrhage, cerebral infarction, myocardial infarction, acute coronary syndrome, severe arrhythmia, acute heart failure, acute exacerbation of congestive heart failure.
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. number of cases of any recorded severe adverse event/reaction per year. Any adverse events/reactions complained of by patients or observed by researchers should be recorded, as well as any newly accompanied disease or aggravation of original symptoms.
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. Reciprocal serum creatinine (1/SCr) slope,the serum creatinine was assessed every 2 months.
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. Malnutrition Inflammation Score is used to assess nutrition and microinflammation status.
all-cause mortality From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years. percentage of subjects who die from any cause during follow-up.
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. percentage of subjects who suffer from severe infection events before dialysis initiation.The severe infection will lead to hospitalization or death.
Infection events refer to death or hospitalization due to infection.
Trial Locations
- Locations (29)
Anhui Provincial Hospital of Chinese Medicine
🇨🇳Hefei, Anhui, China
China PLA General Hospital
🇨🇳Beijing, Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
General hospital of Guangzhou Military command of PLA
🇨🇳Guangzhou, Guangdong, China
Guangzhou No.1 People's Hospital
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Guangxi University Of Chinese Medicine
🇨🇳Nanning, Guangxi, China
TCM Integrated Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
🇨🇳Guiyang, Guizhou, China
Hubei Provincial Hospital of Chinese Medicine
🇨🇳Wuhan, Hubei, China
Shaanxi Provincial Hospital of Chinese Medicine
🇨🇳Xi'an, Shaanxi, China
The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Tong De Hospital, Zhejiang Province
🇨🇳Hangzhou, Zhejiang, China
Liuzhou Hospital of traditional Chinese Medicine
🇨🇳Liuzhou, Guangxi, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Dongzhimen Hospital of Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
🇨🇳Ha'erbin, Heilongjiang, China
First Affiliated Hospital of Tianjin University Of Chinese Medicine
🇨🇳Tianjin, Tianjin, China
Xijing Hospital of The Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Jiangsu Provincial Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China
Hangzhou Hospital of Chinese Medicine
🇨🇳Hangzhou, Zhejiang, China
First Hospital of Peking University
🇨🇳Beijing, Beijing, China
Guang'anmen Hospital China Academy of traditional Chinese Medicine
🇨🇳Beijing, Beijing, China
Xiyuan Hospital, Academy of traditional Chinese Medicine
🇨🇳Beijing, Beijing, China
Third Military Medical University Xinqiao Hospital
🇨🇳Chongqing, Chongqing, China
Huadu District People's Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
Heilongjiang Academy of Traditional Chinese Medicine
🇨🇳Ha'erbin, Heilongjiang, China
First hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China