A clinical study of traditional Chinese medicine combined with western medicine in treatment of primary IgA nephropathy (IgAN) in CKD stage 3

Not Applicable

• Conditions: IgA nephropathy

• Registration Number: ITMCTR2200006488
• Lead Sponsor: Shanghai east hospital (East Hospital affiliated to Tongji University)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Selection criteria: Subjects must meet all of the following selection criteria to enter the introduction period:
1) Females or males aged = 18;
2) Renal biopsy confirms primary IgA nephropathy;
3) 24-hour urine protein quantitative = 0.75 g, or urine protein creatinine ratio (UPCR) = 0.5 g/g;
4) 59=eGFR= 30mL/min/1.73 m2 calculated using the CKD-EPI cooperative creatinine formula (CKD-EPI2009);
5) Males with fertility and female subjects of childbearing age are required to use effective contraception between the time of signing the informed until the end of the trial; Female subjects of childbearing age included women who had not been menopausal and who had not been menopause for more than 2 years; Male subjects were required to agree not to donate sperm during the study period;
6) Be able to sign an informed consent form, understand and agree to comply with the requirements of the study and the trial process arrangement.

Exclusion Criteria

Subjects with any of the following items cannot be screened or enter the introduction phase:
1) Systemic diseases that can cause IgA deposition in the mesangial region of the glomeruli, including but not limited to: Henoch-Sch?nlein purpura, systemic lupus erythematosus, ankylosing spondylitis, etc.; Special types of IgA nephropathy (including minimal lesions with mesenteric IgA deposition, rapidly progressive crescent IgA nephropathy, etc.) and other glomerular diseases (such as diabetes nephropathy, etc.);
2) 24-hour urine protein quantitative >5g;
3) Renal biopsy shows a crescent body ratio of =25%; History of severe gastrointestinal disorders (e.g., active peptic ulcer disease, active gastrointestinal bleeding, history of gastrointestinal perforation, inflammatory bowel disease, chronic diarrhea, etc.); or other conditions that the researcher judges may affect the effectiveness of the drug
4) severe chronic or active infection (including but not limited to tuberculosis infection) in the treatment;
5) Subjects with unstable angina or a history of grade III or IV congestive heart failure or clinically significant arrhythmias;
6) Subjects diagnosed with malignancy in the past 5 years, except for locally recurrent cancers that have been cured (such as basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ or breast cancer, etc.);
7) Subjects with a history of cirrhosis; Subjects with severe osteoporosis who need to be treated; Subjects who have received organ transplantation; Subjects with glaucoma or cataracts who are currently undergoing clinical treatment; Subjects diagnosed with uncontrolled mental illness;
8) Subjects with poor control of type 1 or type 2 diabetes mellitus (glycosylated hemoglobin >8%);
9) Laboratory tests for abnormal liver function (ALT and/or AST> 2 times the upper limit of normal values, ALP > 2.5 times the upper limit of normal values);
10) Laboratory test for serious abnormalities of total blood cholesterol (>500mg/dL or >12.92mmol/L); Positive antibodies for human immunodeficiency virus, positive treponemal antibodies, positive for hepatitis B surface antigen, positive for hepatitis C antibodies;
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) is known to be oversensitive or intolerant to any ingredient of valsartan or a pharmaceutical formulation for experimental purposes;
14) Subjects with a long history of alcohol consumption (defined as drinking 2 servings of alcoholic beverages per day > or 14 servings per week >; One alcoholic beverage is defined as 150ml of wine, 350ml of beer, or 50ml of liquor) or a history of heavy drinking in the 2 weeks prior to screening (defined as drinking 4 alcoholic drinks per day> or 28 servings per week >);
15) Female subjects during pregnancy or breastfeeding;
16) Depending on the investigator's decision, there are other medical or social reasons that lead to the subject's exclusion

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
creatine;urine protein;