IgA nephropathy
Conditions
Interventions
Experimental group:Oral mycophenol sodium enteric-coated tablet and hydroxychloroquine
Sponsors
Shanxi Medical University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) aged 18 years or older; (2) kidney biopsy-confirmed primary IgA nephropathy; (3) proteinuria = 0.75g/d while receiving the maximum tolerated dose of RAS blocker therapy; (4) the latest eGFR measurement = 30 ml/min/1.73m2 (calculated using the CKD-EPI equation).
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the trial: (1) secondary IgA nephropathy, such as due to lupus, liver cirrhosis, Henoch-Schonlein purpura; (2) indication for immunosuppressive therapy with corticosteroids, such as minimal change renal disease with IgA deposits, and crescents present in >50% of glomeruli on a renal biopsy within the last 12 months etc. (3) concurrent interstitial nephritis, membranous nephropathy, or other presence of other indications needing immunosuppressive therapy; (4) administration of systemic glucocorticoids or immunosuppressive agents (including hydroxychloroquine) therapy within the past 3 months; (5) malignant/uncontrolled hypertension, defined as a systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 110 mmHg; (6) a history of malignant tumors within the last 5 years; (7) other etiologies of unstable kidney function, such as acute kidney injury resulting from massive hematuria (past events are not an exclusion); (8) marked hepatic impairment, for example, alanine transaminase levels exceeding 2.0 times the upper limit of normal (ULN), or total bilirubin level surpassing 1.5 times the ULN; (9) pregnant or breastfeeding females, as well as patients with reproduction requirements; (10) active systemic infections, or serious infections within the month preceding enrollment, including human immunodeficiency virus, Hepatitis B or C; (11) leukopenia (white blood cell count below 3.0 × 109/L ), anemia (hemoglobin level lower than 80 g/L), thrombocytopenia (platelet count less than 80 × 109/L), or other hematologic disorders; (12) active peptic ulcerative disease; (13) combined fundus lesions; (14) with contraindications to the use of hydroxychloroquine or EC-MPS; (15) individuals deemed by investigators as unable to follow the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The alteration in 24-hour urine protein quantification value relative to baseline following a 6-month treatment period.;the difference in the rate of eGFR decline at 12 months of treatment. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in 24-hour urinary protein excretion after 12 months of treatment.;The change in eGFR from baseline to 6 and 12 months.;the change in urine albumin-to-creatinine ratio at 6 months and 12 months post-treatment compared to the baseline level.; | — |
Countries
China
Contacts
Public ContactXiaole Su
Shanxi Medical University Second Hospital
Outcome results
None listed