Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath

Study Overview
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Brief Summary
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IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.

Official Title
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Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Chinese Herb Prescription Granule plus prednisone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed by renal biopsy and clinical examination as primary IgA nephropathy. Pathology:upon Lee's grade Ⅲ Age :18-60 years old. Gender and nationality are not limited Chronic Kidney Disease(CKD) Stage 3:（59 ml/min>GFR>30ml/min/1.73m2） 24-hour urine protein:≥1.0g.Informed consent Exclusion Criteria: Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks Patients suffering from acute or rapidly progressive glomerulonephritis Patients continue with active hepatitis B and abnormal liver function tests transaminase Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents Abnormal glucose metabolism, fasting blood glucose more than 6.2mmol/L Pregnancy or breast-feeding women Receiving other clinical trials Associated with other serious diseases and organ dysfunction Combined life-threatening complications such as severe infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Group<br>Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks | Drug: Chinese Herb Prescription Granule plus prednisone<br>* Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule<br>|
| Placebo Comparator: Placebo<br>Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks | Drug: Placebo<br>* Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate | Evaluation of renal function indicators | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours urine protein | Evaluate the therapeutic effect | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgA nephropathy, Therapy of Chinese medicine