Primary IgA nephropathy
Conditions
Interventions
treatment group:Chuanhuang No.1 prescription+ Valsartan
Sponsors
Shanghai Dong Fang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Female or male aged =18 years; 2) Primary IgA nephropathy confirmed by renal biopsy; 3) 24-hour urinary protein quantification =0.75g, or urinary protein-creatinine ratio (UPCR)=0.5 g/g; 4) The chronic kidney disease epidemic cooperative group creatinine formula (CKD-EPI2009) formula was used Calculated 60=eGFR=30mL/min/1.73 m2; 5) Fertile male and female subjects of reproductive age should be informed after signing Use of effective contraception during the period until the end of the trial; Women of childbearing age included women who had not undergone menopause or who had undergone menopause for less than 2 years; Male subjects must agree not to donate sperm during the study; 6) Be able to sign the informed consent, understand and agree to comply with the requirements of the study and the trial process arrangement.
Exclusion criteria
Exclusion criteria: 1) Systemic diseases that can cause IgA deposition in the mesangial region, including but not limited to: Henoch-Schonlein purpura, systemic lupus erythematosus, ankylosing spondylitis, etc. Special types of IgA nephropathy (including minimal lesions with mesangial IgA deposition, rapidly progressing crescental IgA nephropathy, etc.) and other glomerular diseases (such as diabetic nephropathy, etc.); 2) 24-hour urinary protein quantification & GT; 5g; 3) Renal biopsy showed crescent =25%; A history of severe gastrointestinal disease (e.g., active peptic ulcer disease, active gastrointestinal bleeding, history of gastrointestinal perforation, inflammatory bowel disease, and chronic diarrhea); Or other conditions that the investigator determined might affect the drug's effect 4) Treated severe chronic or active infection (including but not limited to tuberculosis infection); 5) Subjects with a history of unstable angina pectoris or class III or IV congestive heart failure or clinically meaningful arrhythmia; 6) Subjects diagnosed with malignancy within the past 5 years, except locally recurrent cancers that have been cured (e.g. basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer); 7) Subjects with a history of cirrhosis; Subjects with severe osteoporosis requiring treatment; Subjects who have undergone organ transplants; Subjects with glaucoma or cataract who currently require clinical treatment; Subjects diagnosed with uncontrolled mental illness; 8) Subjects with poorly controlled type 1 or type 2 diabetes (glycated hemoglobin & GT; 8%). 9) Laboratory tests for abnormal liver function (ALT and/or AST> Twice the upper limit of normal, ALP> 2.5 times the upper limit of normal); 10) Severe abnormalities in total blood cholesterol (> 500 mg/dL or & gt; Tendency for 12.92 L); HIV antibody positive, treponema pallidum antibody positive, hepatitis B surface antigen positive, hepatitis C antibody positive; 11) Received immunosuppressive drugs other than glucocorticoids within 6 months before the screening period; 12) Received any systemic glucocorticoid therapy within 3 months prior to the screening period; 13) Known hypersensitivity or intolerance to valsartan or any ingredient in an experimental drug formulation; 14) A history of chronic alcohol use (defined as daily consumption of alcoholic beverages & GT; 2 servings or weekly > 14 subjects; One alcoholic drink was defined as 150ml wine, 350ml beer, or 50ml liquor) or a history of heavy alcohol consumption in the 2 weeks prior to screening (defined as daily consumption of alcoholic beverages). 4 servings or weekly > 28); 15) Pregnant or lactating female subjects; 16) At the investigator's discretion, there are other medical or social reasons for exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| eGFR;24hupr;urine albumin-creatinine ratio;TCM symptom and syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| CRP;IL-6;IL-1ß;TNF-a;ROS;SOD;MDA; | — |
Countries
China
Contacts
Public ContactNa Liu
Outcome results
None listed