Chinese Medicine on Deferring Dialysis Initiation (C-MODDI)
End-Stage Renal Disease
About this trial
This is an interventional treatment trial for End-Stage Renal Disease focused on measuring Chronic Kidney Disease,, End-Stage Renal Disease,, Traditional Chinese Medicine,, dialysis initiation.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Sites / Locations
- Anhui Provincial Hospital of Chinese Medicine
- China PLA General Hospital
- China-Japan Friendship Hospital
- Dongzhimen Hospital of Beijing University of Chinese Medicine
- First Hospital of Peking University
- Guang'anmen Hospital China Academy of traditional Chinese Medicine
- Xiyuan Hospital, Academy of traditional Chinese Medicine
- Third Military Medical University Xinqiao Hospital
- General hospital of Guangzhou Military command of PLA
- Guangzhou No.1 People's Hospital
- Huadu District People's Hospital of Guangzhou
- TCM Integrated Hospital of Southern Medical University
- Guangdong Provincial Hospital of Chinese Medicine
- Liuzhou Hospital of traditional Chinese Medicine
- First Affiliated Hospital of Guangxi University Of Chinese Medicine
- First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
- First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
- Heilongjiang Academy of Traditional Chinese Medicine
- Hubei Provincial Hospital of Chinese Medicine
- Jiangsu Provincial Hospital of Chinese Medicine
- Shaanxi Provincial Hospital of Chinese Medicine
- Xijing Hospital of The Fourth Military Medical University
- Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
- First hospital of Shanxi Medical University
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- First Affiliated Hospital of Tianjin University Of Chinese Medicine
- Hangzhou Hospital of Chinese Medicine
- Tong De Hospital, Zhejiang Province
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
CKD-related management group
CM therapies 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.
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.