Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Science and Technology of the People´s Republic of China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-related management group | Active Comparator | 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. |
|
| CM therapies group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM therapies | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xusheng Liu, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| Ping Li, PhD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital of Chinese Medicine | Hefei | Anhui | 230000 | China | ||
| China PLA General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22178174 | Background | 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. | |
| 23371456 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| CKD-related management | Drug | 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. |
|
|
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. | 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 | 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 | 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 | 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. |
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 | 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 | 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 | 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. |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100000 | China |
| Dongzhimen Hospital of Beijing University of Chinese Medicine | Beijing | Beijing Municipality | 100000 | China |
| First Hospital of Peking University | Beijing | Beijing Municipality | 100000 | China |
| Guang'anmen Hospital China Academy of traditional Chinese Medicine | Beijing | Beijing Municipality | 100000 | China |
| Xiyuan Hospital, Academy of traditional Chinese Medicine | Beijing | Beijing Municipality | 100000 | China |
| Third Military Medical University Xinqiao Hospital | Chongqing | Chongqing Municipality | 400037 | China |
| General hospital of Guangzhou Military command of PLA | Guangzhou | Guangdong | 510000 | China |
| Guangzhou No.1 People's Hospital | Guangzhou | Guangdong | 510000 | China |
| Huadu District People's Hospital of Guangzhou | Guangzhou | Guangdong | 510000 | China |
| TCM Integrated Hospital of Southern Medical University | Guangzhou | Guangdong | 510000 | China |
| Guangdong Provincial Hospital of Chinese Medicine | Guangzhou | Guangdong | 510120 | China |
| Liuzhou Hospital of traditional Chinese Medicine | Liuzhou | Guangxi | 545000 | China |
| First Affiliated Hospital of Guangxi University Of Chinese Medicine | Nanning | Guangxi | 530000 | China |
| First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine | Guiyang | Guizhou | 550000 | China |
| First Affiliated Hospital of Heilongjiang University Of Chinese Medicine | Harbin | Heilongjiang | 150000 | China |
| Heilongjiang Academy of Traditional Chinese Medicine | Harbin | Heilongjiang | 150000 | China |
| Hubei Provincial Hospital of Chinese Medicine | Wuhan | Hubei | 430000 | China |
| Jiangsu Provincial Hospital of Chinese Medicine | Nanjing | Jiangsu | 210000 | China |
| Shaanxi Provincial Hospital of Chinese Medicine | Xi'an | Shaanxi | 710000 | China |
| Xijing Hospital of The Fourth Military Medical University | Xi'an | Shaanxi | 710000 | China |
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| The Sixth People's Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200000 | China |
| First hospital of Shanxi Medical University | Taiyuan | Shanxi | 030000 | China |
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 610000 | China |
| First Affiliated Hospital of Tianjin University Of Chinese Medicine | Tianjin | Tianjin Municipality | 300000 | China |
| Hangzhou Hospital of Chinese Medicine | Hangzhou | Zhejiang | 310000 | China |
| Tong De Hospital, Zhejiang Province | Hangzhou | Zhejiang | 310000 | China |
| Background |
| 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. |
| Background | 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. |
| 21555505 | Background | 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. |
| 19455195 | Background | 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. |
| 20634325 | Background | 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. |
| 21059968 | Background | 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. |
| 20519231 | Background | 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. |
| 20581422 | Background | 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. |
| 24492525 | Background | 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. |
| 21551086 | Background | 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. |
| 22944441 | Background | 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. |
| 19563735 | Background | 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. |
| 21731165 | Background | 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. |
| Background | Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China. Beijing: People's Medicial Publishing House; 2010 |
| 23958927 | Background | Emmanuel AV, Krogh K, Bazzocchi G, Leroi AM, Bremers A, Leder D, van Kuppevelt D, Mosiello G, Vogel M, Perrouin-Verbe B, Coggrave M, Christensen P; Members of working group on Trans Anal Irrigation from UK, Denmark, Italy, Germany, France and Netherlands. Consensus review of best practice of transanal irrigation in adults. Spinal Cord. 2013 Oct;51(10):732-8. doi: 10.1038/sc.2013.86. Epub 2013 Aug 20. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| D013812 | Therapeutics |
| D000529 | Complementary Therapies |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
Not provided
Not provided