IgA Nephropathy
Conditions
Keywords
IgA nephropathy, Therapy of 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.
Interventions
DRUGChinese Herb Prescription Granule plus prednisone
Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule
DRUGPlacebo
Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule
Sponsors
Shanghai 6th People's Hospital
RenJi Hospital
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glomerular filtration rate | 12 months | Evaluation of renal function indicators |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 hours urine protein | 12 months | Evaluate the therapeutic effect |
Countries
China
Contacts
Primary ContactYUEYI DENG, Dr.
Outcome results
None listed