Immunoglobulin A nephropathy
Conditions
Interventions
Experimental group:Sinomenine+Losartan
Control group:Sinomenine Placebo+Losartan
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)According to the 2021 KDIGO guidelines for glomerulonephritis, patients with confirmed diagnosis of primary IgA nephropathy based on renal biopsy pathology; (2)Age ranging from 18 to 65 years old (inclusive) with no gender restrictions; (3)eGFR=45mL/min/1.73m^2; (4)After receiving the maximum or tolerated dose of ACEI and ARB for at least 3 months, the 24-hour urine protein-creatinine ratio =0.5 g/g or urine protein quantification =0.5 g/24 h;during the run-in period, at least two 24-hour urine tests and blood creatinine test results are required to determine whether the above standards are met; (5)Voluntary participants who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Have been, or are receiving, or have an indication for treatment with systemic (oral or intravenous) immunosuppressants (eg, glucocorticoids, Rhinoper, mycophenolate mycofenolate, cyclophosphamide, etc.) in the 3 months prior to randomization; (2)Contraindications to the use of Sinomenine: history of asthma, decompensated cirrhosis, or hepatic insufficiency [ALT or AST = 1.5 ULN]; (3)Patients with positive hepatitis B surface antigen, hepatitis C antibody, or HIV antigen antibody; (4)Clinical evidence of active tuberculosis as judged by the investigator; (5)Uncontrolled hypertension (>140/90mmHg); (6)Type 1 or type 2 diabetes or glycated hemoglobin = 6.5%; (7)Personal history of malignancy in the past 5 years; (8)Serious, progressive, uncontrolled cardiac, cerebrovascular, and psychiatric diseases; (9)Unstable renal function due to other causes, such as a decrease in GFR of more than 30% after ACEI/ARB use during the induction phase; (10)Those who have a definite allergic reaction to any of the drugs in this study (such as other preparations containing Sinomenine, RAS blockers); (11)Secondary IgA nephropathy: such as systemic lupus erythematosus, hepatitis B-related glomerulonephritis, cirrhosis, allergic purpura, etc; (12)Pregnant women and women who are breastfeeding or planning to become pregnant, or women of childbearing age have a positive pregnancy test at screening, or do not agree to use contraception during the study; (13)Those who are participating in other drug clinical trials or have participated in other clinical trials within 3 months; (14)Judged by the investigator to be unsuitable for inclusion in the study (such as poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urine protein-creatinine ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour urine protein quantification;24-hour urine albumin-creatinine ratio;Glomerular filtration rate;Urine red blood cell count;Composite kidney disease endpoint;Red blood cells in urine have turned negative;EuroQol Five Dimensions Questionnaire;Traditional Chinese Medicine Wet Syndrome Evaluation Scale; | — |
Countries
China
Contacts
Public ContactFuhua Lu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed