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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

875

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jul 2014

Longer than P75 for phase_1

Geographic Reach

1 country

29 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.4 years study duration

Study Start

First participant enrolled

July 1, 2014

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed

Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

6.4 years

First QC Date

July 16, 2014

Last Update Submit

December 23, 2019

Conditions

End-Stage Renal Disease

Keywords

Chronic Kidney Disease,End-Stage Renal Disease,Traditional Chinese Medicine,dialysis initiation.

Outcome Measures

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

Secondary Outcomes (6)

all-cause mortality
From enrollment to dialysis initiation or death.The duration of follow up will be for a maximum of 4 years.
Cardio-cerebro vascular events
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.
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
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
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.
+1 more secondary outcomes

Other Outcomes (5)

Liver function
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
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.
+2 more other outcomes

Study Arms (2)

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.

Drug: CKD-related management

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.

Drug: CM therapiesDrug: CKD-related management

Interventions

CM therapiesDRUG

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.

Also known as: Traditional Chinese medicine (TCM) treatment, TCM treatment, Complementary Therapies

CM therapies group

CKD-related managementDRUG

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.

Also known as: modern medicine, Western medicine

CKD-related management groupCM therapies group

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Anhui Provincial Hospital of Chinese Medicine

Hefei, Anhui, 230000, China

Location

China PLA General Hospital