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

Not Applicable

• Conditions: IgA Nephropathy
• Interventions: Drug: Chinese Herb Prescription Granule plus prednisone; Drug: Placebo

• Registration Number: NCT01879514
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-03-25
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-13
• Last Update Submitted: 2013-06-13
• Study First Posted: 2013-06-17
• Last Update Posted: 2013-06-17
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	12 months	Evaluation of renal function indicators

Secondary Outcome Measures

Name	Time	Method
24 hours urine protein	12 months	Evaluate the therapeutic effect

Trial Locations

Locations (1)

Department of Nephrology,Longhua Hospital; 🇨🇳 Shanghai, China