Status:
UNKNOWN
Chinese Medicine on Deferring Dialysis Initiation
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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...
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,...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
875 Patients enrolled
Trial Details
Trial ID
NCT02194946
Start Date
July 1 2014
End Date
December 1 2020
Last Update
December 26 2019
Active Locations (29)
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1
Anhui Provincial Hospital of Chinese Medicine
Hefei, Anhui, China, 230000
2
China PLA General Hospital
Beijing, Beijing Municipality, China, 100000
3
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100000
4
Dongzhimen Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China, 100000