Clinical trial NCT02194946: Chinese Medicine on Deferring Dialysis Initiation
Official title: Effectiveness of Chinese Medicine on Deferring Dialysis Initiation for Stage 5 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: End-Stage Renal Disease
Keywords: Chronic Kidney Disease,
End-Stage Renal Disease,
Traditional Chinese Medicine,
dialysis initiation.
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2014-07-21
Enrollment: 875
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Time to initiation of dialysis from enrollment.
timeFrame: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Secondary outcomes:
measure: all-cause mortality
timeFrame: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
measure: Cardio-cerebro vascular events
timeFrame: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
measure: Hospitalization or death caused by severe infection.
timeFrame: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
measure: incidence of severe adverse event/reaction
timeFrame: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
measure: Slope of reciprocal serum creatinine
timeFrame: 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.
measure: Nutrition and microinflammation status
timeFrame: 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.
Other outcomes:
measure: Liver function
timeFrame: 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.
measure: Complete blood count
timeFrame: 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.
measure: Routine stool test + occult blood
timeFrame: 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.
measure: Electrocardiogram
timeFrame: 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.
measure: Adverse event/reaction
timeFrame: 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.
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital of Chinese Medicine
state: Anhui
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: First Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital China Academy of traditional Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Xiyuan Hospital, Academy of traditional Chinese Medicine
state: Beijing
city: Chongqing
country: China
facility: Third Military Medical University Xinqiao Hospital
state: Chongqing
city: Guangzhou
country: China
facility: General hospital of Guangzhou Military command of PLA
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou No.1 People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: TCM Integrated Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Hospital of traditional Chinese Medicine
state: Guangxi
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi University Of Chinese Medicine
state: Guangxi
city: Guiyang
country: China
facility: First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
state: Guizhou
city: Ha'erbin
country: China
facility: First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
state: Heilongjiang
city: Ha'erbin
country: China
facility: Heilongjiang Academy of Traditional Chinese Medicine
state: Heilongjiang
city: Wuhan
country: China
facility: Hubei Provincial Hospital of Chinese Medicine
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Chinese Medicine
state: Jiangsu
city: Xi'an
country: China
facility: Shaanxi Provincial Hospital of Chinese Medicine
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of The Fourth Military Medical University
state: Shaanxi
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Taiyuan
country: China
facility: First hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Tianjin
country: China
facility: First Affiliated Hospital of Tianjin University Of Chinese Medicine
state: Tianjin
city: Hangzhou
country: China
facility: Hangzhou Hospital of Chinese Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Tong De Hospital, Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Xusheng Liu, MD
role: STUDY_DIRECTOR
affiliation: China-Japan Friendship Hospital
name: Ping Li, PhD
role: PRINCIPAL_INVESTIGATOR
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