Chinese Medicine on Deferring Dialysis Initiation (C-MODDI)

December 23, 2019 updated by: Liu Xu-sheng, Guangdong Provincial Hospital of Traditional Chinese Medicine

Effectiveness of Chinese Medicine on Deferring Dialysis Initiation for Stage 5 Chronic Kidney Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

875

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital of Chinese Medicine
    • Beijing
      • Beijing, Beijing, China, 100000
        • China PLA General Hospital
      • Beijing, Beijing, China, 100000
        • China-Japan Friendship Hospital
      • Beijing, Beijing, China, 100000
        • Dongzhimen Hospital of Beijing University of Chinese Medicine
      • Beijing, Beijing, China, 100000
        • First Hospital of Peking University
      • Beijing, Beijing, China, 100000
        • Guang'anmen Hospital China Academy of traditional Chinese Medicine
      • Beijing, Beijing, China, 100000
        • Xiyuan Hospital, Academy of traditional Chinese Medicine
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Third Military Medical University Xinqiao Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine
      • Guangzhou, Guangdong, China, 510000
        • General Hospital of Guangzhou Military Command of PLA
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou No.1 People's Hospital
      • Guangzhou, Guangdong, China, 510000
        • Huadu District People's Hospital of Guangzhou
      • Guangzhou, Guangdong, China, 510000
        • TCM Integrated Hospital of Southern Medical University
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • Liuzhou Hospital of Traditional Chinese Medicine
      • Nanning, Guangxi, China, 530000
        • First Affiliated Hospital of Guangxi University Of Chinese Medicine
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150000
        • First Affiliated Hospital of Heilongjiang University of Chinese Medicine
      • Ha'erbin, Heilongjiang, China, 150000
        • Heilongjiang Academy of Traditional Chinese Medicine
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Hubei Provincial Hospital of Chinese Medicine
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial Hospital of Chinese Medicine
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Shaanxi Provincial Hospital of Chinese Medicine
      • Xi'an, Shaanxi, China, 710000
        • Xijing Hospital of the Fourth Military Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200000
        • The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • First Affiliated Hospital of Tianjin University of Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Hangzhou hospital of Chinese medicine
      • Hangzhou, Zhejiang, China, 310000
        • Tong De Hospital, Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CKD-related management 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.
Drug: CKD-related management
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.
Other Names:
  • modern medicine
  • Western medicine
Experimental: CM therapies group
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.
Drug: CKD-related management
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.
Other Names:
  • modern medicine
  • Western medicine
Drug: CM therapies
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.
Other Names:
  • Traditional Chinese medicine (TCM) treatment
  • TCM treatment
  • Complementary Therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to initiation of dialysis from enrollment.
Time Frame: 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.
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 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.
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Cardio-cerebro vascular events
Time Frame: 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.
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Hospitalization or death caused by severe infection.
Time Frame: 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.
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
incidence of severe adverse event/reaction
Time Frame: 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.
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Slope of reciprocal serum creatinine
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.
Reciprocal serum creatinine (1/SCr) slope,the serum creatinine was assessed every 2 months.
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.
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.
Malnutrition Inflammation Score is used to assess 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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function
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.
aspartate aminotransferase (AST),alanine aminotransferase (ALT)
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.
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.
Complete blood count
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.
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.
Routine stool test + occult blood
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.
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.
Electrocardiogram
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.
Adverse event/reaction
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.
number of cases of any recorded adverse event/reaction per year.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Study Director: Xusheng Liu, MD, Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Principal Investigator: Ping Li, PhD, China-Japan Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013BAI02B04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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