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AzTrials

End-Stage Renal DiseasePhase 1/2C-MODDINCT02194946

Chinese Medicine on Deferring Dialysis Initiation

A Phase 1/2 study testing CM therapies and CKD-related management in people with End-Stage Renal Disease, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 29 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
End-Stage Renal Disease
What is being tested?
CM therapies and CKD-related management
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
875 participants
Where
29 sitesChina
Study dates
Jul 2014to Dec 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

China29 sites

  • China PLA General Hospital

    Beijing, Beijing Municipality, 100000

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100000

  • Dongzhimen Hospital of Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100000

  • First Hospital of Peking University

    Beijing, Beijing Municipality, 100000

  • Guang'anmen Hospital China Academy of traditional Chinese Medicine

    Beijing, Beijing Municipality, 100000

  • Xiyuan Hospital, Academy of traditional Chinese Medicine

    Beijing, Beijing Municipality, 100000

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610000

  • Third Military Medical University Xinqiao Hospital

    Chongqing, Chongqing Municipality, 400037

  • General hospital of Guangzhou Military command of PLA

    Guangzhou, Guangdong, 510000

  • Guangzhou No.1 People's Hospital

    Guangzhou, Guangdong, 510000

  • Huadu District People's Hospital of Guangzhou

    Guangzhou, Guangdong, 510000

  • TCM Integrated Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • Guangdong Provincial Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

  • First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine

    Guiyang, Guizhou, 550000

  • Hangzhou Hospital of Chinese Medicine

    Hangzhou, Zhejiang, 310000

  • Tong De Hospital, Zhejiang Province

    Hangzhou, Zhejiang, 310000

  • First Affiliated Hospital of Heilongjiang University Of Chinese Medicine

    Harbin, Heilongjiang, 150000

  • Heilongjiang Academy of Traditional Chinese Medicine

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital of Chinese Medicine

    Hefei, Anhui, 230000

  • Liuzhou Hospital of traditional Chinese Medicine

    Liuzhou, Guangxi, 545000

  • Jiangsu Provincial Hospital of Chinese Medicine

    Nanjing, Jiangsu, 210000

  • First Affiliated Hospital of Guangxi University Of Chinese Medicine

    Nanning, Guangxi, 530000

  • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200000

  • The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200000

  • First hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • First Affiliated Hospital of Tianjin University Of Chinese Medicine

    Tianjin, Tianjin Municipality, 300000

  • Hubei Provincial Hospital of Chinese Medicine

    Wuhan, Hubei, 430000

  • Shaanxi Provincial Hospital of Chinese Medicine

    Xi'an, Shaanxi, 710000

  • Xijing Hospital of The Fourth Military Medical University

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
CM therapies, CKD-related management
Keywords
Chronic Kidney Disease,, End-Stage Renal Disease,, Traditional Chinese Medicine,, dialysis initiation.
Medical subject headings
Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM therapiesDrug

    Also called Traditional Chinese medicine (TCM) treatment, TCM treatment, Complementary 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.

  • CKD-related managementDrug

    Also called modern medicine, Western medicine

    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.

Study groups in NCT02194946
Study groupRoleWhat they receive
CKD-related management groupActive comparatorPatients 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.
Receives: Drug: CKD-related management
CM therapies groupExperimentalParticipants 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.
Receives: Drug: CM therapies; Drug: CKD-related management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    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.

    Measured: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.

Secondary outcomes (6)

  1. all-cause mortality

    percentage of subjects who die from any cause during follow-up.

    Measured: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.

  2. 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.

    Measured: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.

  3. 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.

    Measured: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.

  4. 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.

    Measured: From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.

  5. Slope of reciprocal serum creatinine

    Reciprocal serum creatinine (1/SCr) slope,the serum creatinine was assessed every 2 months.

    Measured: 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.

  6. Nutrition and microinflammation status

    Malnutrition Inflammation Score is used to assess nutrition and microinflammation status.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
875 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194946
Sponsor's protocol ID
2013BAI02B04
Acronym
C-MODDI
Status last verified
Dec 2019
First submitted
16 Jul 2014
Last updated
26 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Wang YJ, He LQ, Sun W, Lu Y, Wang XQ, Zhang PQ, Wei LB, Cao SL, Yang NZ, Ma HZ, Gao J, Li P, Tao XJ, Yuan FH, Li J, Yao C, Liu X. Optimized project of traditional Chinese medicine in treating chronic kidney disease stage 3: a multicenter double-blinded randomized controlled trial. J Ethnopharmacol. 2012 Feb 15;139(3):757-64. doi: 10.1016/j.jep.2011.12.009. Epub 2011 Dec 13.

    PubMed 22178174

  • Zou C, Lu ZY, Wu YC, Yang LH, Su GB, Jie XN, Liu XS. Colon may provide new therapeutic targets for treatment of chronic kidney disease with Chinese medicine. Chin J Integr Med. 2013 Feb;19(2):86-91. doi: 10.1007/s11655-013-1351-8. Epub 2013 Jan 31.

    PubMed 23371456

  • 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.

  • Rosansky S, Glassock RJ, Clark WF. Early start of dialysis: a critical review. Clin J Am Soc Nephrol. 2011 May;6(5):1222-8. doi: 10.2215/CJN.09301010.

    PubMed 21555505

  • Rosansky SJ, Clark WF, Eggers P, Glassock RJ. Initiation of dialysis at higher GFRs: is the apparent rising tide of early dialysis harmful or helpful? Kidney Int. 2009 Aug;76(3):257-61. doi: 10.1038/ki.2009.161. Epub 2009 May 20.

    PubMed 19455195

  • Wright S, Klausner D, Baird B, Williams ME, Steinman T, Tang H, Ragasa R, Goldfarb-Rumyantzev AS. Timing of dialysis initiation and survival in ESRD. Clin J Am Soc Nephrol. 2010 Oct;5(10):1828-35. doi: 10.2215/CJN.06230909. Epub 2010 Jul 15.

    PubMed 20634325

  • Rosansky SJ, Eggers P, Jackson K, Glassock R, Clark WF. Early start of hemodialysis may be harmful. Arch Intern Med. 2011 Mar 14;171(5):396-403. doi: 10.1001/archinternmed.2010.415. Epub 2010 Nov 8.

    PubMed 21059968

  • Hwang SJ, Yang WC, Lin MY, Mau LW, Chen HC; Taiwan Society of Nephrology. Impact of the clinical conditions at dialysis initiation on mortality in incident haemodialysis patients: a national cohort study in Taiwan. Nephrol Dial Transplant. 2010 Aug;25(8):2616-24. doi: 10.1093/ndt/gfq308. Epub 2010 Jun 2.

    PubMed 20519231

  • Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. A randomized, controlled trial of early versus late initiation of dialysis. N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27.

    PubMed 20581422

  • Nesrallah GE, Mustafa RA, Clark WF, Bass A, Barnieh L, Hemmelgarn BR, Klarenbach S, Quinn RR, Hiremath S, Ravani P, Sood MM, Moist LM; Canadian Society of Nephrology. Canadian Society of Nephrology 2014 clinical practice guideline for timing the initiation of chronic dialysis. CMAJ. 2014 Feb 4;186(2):112-7. doi: 10.1503/cmaj.130363. No abstract available.

    PubMed 24492525

  • Tattersall J, Dekker F, Heimburger O, Jager KJ, Lameire N, Lindley E, Van Biesen W, Vanholder R, Zoccali C; ERBP Advisory Board. When to start dialysis: updated guidance following publication of the Initiating Dialysis Early and Late (IDEAL) study. Nephrol Dial Transplant. 2011 Jul;26(7):2082-6. doi: 10.1093/ndt/gfr168. Epub 2011 May 5. No abstract available.

    PubMed 21551086

  • Li Z, Zhu L, Zhang H, Yang J, Zhao J, Du D, Meng J, Yang F, Zhao Y, Sun J. Protective effect of a polysaccharide from stem of Codonopsis pilosula against renal ischemia/reperfusion injury in rats. Carbohydr Polym. 2012 Nov 6;90(4):1739-43. doi: 10.1016/j.carbpol.2012.07.062. Epub 2012 Jul 31.

    PubMed 22944441

  • Song J, Meng L, Li S, Qu L, Li X. A combination of Chinese herbs, Astragalus membranaceus var. mongholicus and Angelica sinensis, improved renal microvascular insufficiency in 5/6 nephrectomized rats. Vascul Pharmacol. 2009 May-Jun;50(5-6):185-93. doi: 10.1016/j.vph.2009.01.005.

    PubMed 19563735

  • Tong Y, Han B, Guo H, Liu Y. Protection of Chinese herbs against adenine-induced chronic renal failure in rats. Afr J Tradit Complement Altern Med. 2010;7(4):331-8. doi: 10.4314/ajtcam.v7i4.56701. Epub 2010 Jul 3.

    PubMed 21731165

  • Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China. Beijing: People's Medicial Publishing House; 2010

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CM therapies and CKD-related management in people with End-Stage Renal Disease, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 29 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02194946, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.

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