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

Shanghai University of Traditional Chinese Medicine200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

IgA Nephropathy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Glomerular filtration rate

Evaluation of renal function indicators

Time frame: 12 months

Secondary Outcomes

24 hours urine protein

Evaluate the therapeutic effect