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Chinese Medicine on Deferring Dialysis Initiation (C-MODDI)

Primary Purpose

End-Stage Renal Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CM therapies
CKD-related management
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

CKD-related management group

CM therapies group

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to initiation of dialysis from enrollment.
Averaged time from enrollment to dialysis initiation or death from any cause, whichever comes first. Patients commence dialysis based on the following criteria: 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. 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

all-cause mortality
percentage of subjects who die from any cause during follow-up.
Cardio-cerebro vascular events
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.
Hospitalization or death caused by severe infection.
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.
incidence of severe adverse event/reaction
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
Reciprocal serum creatinine (1/SCr) slope,the serum creatinine was assessed every 2 months.
Nutrition and microinflammation status
Malnutrition Inflammation Score is used to assess nutrition and microinflammation status.

Full Information

First Posted
July 16, 2014
Last Updated
December 23, 2019
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02194946
Brief Title
Chinese Medicine on Deferring Dialysis Initiation
Acronym
C-MODDI
Official Title
Effectiveness of Chinese Medicine on Deferring Dialysis Initiation for Stage 5 Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
Chronic Kidney Disease,, End-Stage Renal Disease,, Traditional Chinese Medicine,, dialysis initiation.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
875 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CKD-related management group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CM therapies group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CM therapies
Other Intervention Name(s)
Traditional Chinese medicine (TCM) treatment, TCM treatment, Complementary Therapies
Intervention Description
The choice of CM patterns will be at the treating physician's discretion. The dosing regimen of Chinese herbs and Chinese patent medicine will be as per the 2010 Chinese pharmacopoeia.The oral Chinese herbal formula will be composed of 18 herbs:Radix Astragali, Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Rhizoma diosscoreae, Poria, Semen Cuscutae, Radix Morindae Officinalis, Herba Epimedii, Herba Cistanches, Fructus Ligustri Lucidi, Rhizoma Polygonati, Fructus Amomi, Herba Agastaches, Rhizoma Coptidis, Radix et Rhizoma Rhei, Semen Coicis, Radix Salviae Miltiorrhizae, and stir-baked Semen Persicae. The Chinese herbal formula via Colonic administration will be composed of 3 herbs: Radix et Rhizoma Rhei, Calcined Concha Osterae, Herba Taraxaci.
Intervention Type
Drug
Intervention Name(s)
CKD-related management
Other Intervention Name(s)
modern medicine, Western medicine
Intervention Description
Western medicine treatment for CKD are practised following KDIGO and KDOQI guidelines, to reach the recommended goals of nutrition, blood pressure, hemoglobulin, electrolytes, fluid control and acid-base balance.
Primary Outcome Measure Information:
Title
Time to initiation of dialysis from enrollment.
Description
Averaged time from enrollment to dialysis initiation or death from any cause, whichever comes first. Patients commence dialysis based on the following criteria: 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. 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.
Time Frame
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Secondary Outcome Measure Information:
Title
all-cause mortality
Description
percentage of subjects who die from any cause during follow-up.
Time Frame
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Title
Cardio-cerebro vascular events
Description
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.
Time Frame
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Title
Hospitalization or death caused by severe infection.
Description
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.
Time Frame
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Title
incidence of severe adverse event/reaction
Description
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.
Time Frame
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Title
Slope of reciprocal serum creatinine
Description
Reciprocal serum creatinine (1/SCr) slope,the serum creatinine was assessed every 2 months.
Time Frame
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.
Title
Nutrition and microinflammation status
Description
Malnutrition Inflammation Score is used to assess nutrition and microinflammation status.
Time Frame
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 Pre-specified Outcome Measures:
Title
Liver function
Description
aspartate aminotransferase (AST),alanine aminotransferase (ALT)
Time Frame
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.
Title
Complete blood count
Description
Complete blood count
Time Frame
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.
Title
Routine stool test + occult blood
Description
Routine stool test + occult blood
Time Frame
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.
Title
Electrocardiogram
Description
Electrocardiogram
Time Frame
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.
Title
Adverse event/reaction
Description
number of cases of any recorded adverse event/reaction per year.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xusheng Liu, MD
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ping Li, PhD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital of Chinese Medicine
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
China PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Dongzhimen Hospital of Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
First Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Guang'anmen Hospital China Academy of traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Xiyuan Hospital, Academy of traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Third Military Medical University Xinqiao Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
General hospital of Guangzhou Military command of PLA
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangzhou No.1 People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Huadu District People's Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
TCM Integrated Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Liuzhou Hospital of traditional Chinese Medicine
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Facility Name
First Affiliated Hospital of Guangxi University Of Chinese Medicine
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Name
First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
First Affiliated Hospital of Heilongjiang University Of Chinese Medicine
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Heilongjiang Academy of Traditional Chinese Medicine
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Facility Name
Hubei Provincial Hospital of Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Jiangsu Provincial Hospital of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Shaanxi Provincial Hospital of Chinese Medicine
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Xijing Hospital of The Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
First hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030000
Country
China
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
First Affiliated Hospital of Tianjin University Of Chinese Medicine
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Hangzhou Hospital of Chinese Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Tong De Hospital, Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
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Chinese Medicine on Deferring Dialysis Initiation

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