Primary IgA Nephropathy
Conditions
Keywords
liver-kidney yin deficiency syndrome, primary severe IgA nephropathy, Lee's grade Ⅲ
Brief summary
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.
Detailed description
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.
Interventions
DRUGWM (Shentong Granules)
Shentong Granules with Prednisone
DRUGHormone (prednisone)
Oral prednisone
Sponsors
RenJi Hospital
Ruijin Hospital
Shanghai 6th People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above; 2. TCM is liver kidney yin deficiency syndrome; 3. age 18-70 years old, sex, nationality is not limited; 4. CKD phase 2-4 （89 ml/min\>eGFR（EPI Formula）\>15ml/min/1.73m2）; 5. 24 hour urinary protein≥1g.
Exclusion criteria
1. It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks; 2. It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks; 3. Acute or progressive glomerulonephritis patients; 4. Severe complications threat to life, such as severe infection; 5. Active hepatitis B and liver function test sustained abnormal; 6. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone; 7. Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L; 8. Gravid or lactation woman; 9. Other clinical trials are being studied; 10. Merger with other serious disease and dysfunction of the organ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glomerular filtration rate | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein excretion | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks |
| serum creatinine | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks |
| serum Lipid | Half-yearly |
| TCM syndrome score | changes from Baseline to 2, 4, 12, 24,36 and 48 weeks |
Countries
China
Contacts
Primary ContactYueyi Deng, MD.
Backup ContactWanjia Chen, MS.
Outcome results
None listed