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Chinese Medicine on Deferring Dialysis Initiation (C-MODDI)

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ClinicalTrials.gov Identifier: NCT02194946
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2014
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Xu-sheng, Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Drug: CM therapies Drug: CKD-related management Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 875 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Chinese Medicine on Deferring Dialysis Initiation for Stage 5 Chronic Kidney Disease
Study Start Date : July 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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: 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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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.

  6. 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.


Other Outcome Measures:
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194946


  Show 29 Study Locations
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Study Director: Xusheng Liu, MD Guangdong Provincial Hospital of Traditional Chinese Medicine
Principal Investigator: Ping Li, PhD China-Japan Friendship Hospital

Publications:
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney inter., Suppl.2013;3: 1-150.
Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China. Beijing: People's Medicial Publishing House; 2010

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Responsible Party: Liu Xu-sheng, Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02194946     History of Changes
Other Study ID Numbers: 2013BAI02B04
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Liu Xu-sheng, Guangdong Provincial Hospital of Traditional Chinese Medicine:
Chronic Kidney Disease,
End-Stage Renal Disease,
Traditional Chinese Medicine,
dialysis initiation.

Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases