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

Shanghai University of Traditional Chinese Medicine

Status: Unknown

Conditions: IgA Nephropathy

Treatments: Drug: Chinese Herb Prescription Granule plus prednisone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01879514

SHDC12010114

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Combination Group

Experimental group

Description:

Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks

Treatment:

Drug: Chinese Herb Prescription Granule plus prednisone

Placebo

Placebo Comparator group

Description:

Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks

Treatment:

Drug: Placebo