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

NCT ID: NCT01879514

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

Conditions

IgA Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combination Group

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

Group Type: EXPERIMENTAL

Chinese Herb Prescription Granule plus prednisone

Intervention Type: DRUG

Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule

Interventions

Chinese Herb Prescription Granule plus prednisone

Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule

Intervention Type: DRUG

Placebo

Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

yueyi deng

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YueYi Deng, PHD,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of Traditional Chinese Medicine

Locations

Department of Nephrology,Longhua Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

YUEYI DENG, Dr.

Role: CONTACT

lhkidney@hotmail.com

64385700 ext. 3222

Facility Contacts

YueYI Deng, Dr.

Role: primary

lhkidney@hotmail.com

64385700 ext. 3222

Other Identifiers

SHDC12010114

Identifier Type: -

Identifier Source: org_study_id