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Recruiting NCT06676007

A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy

Trial Parameters

Condition IgA Nephropathy (IgAN)
Sponsor Sichuan Provincial People's Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-10-30
Completion 2026-12-31
Interventions
Gd-IgA1 test

Brief Summary

To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.

Eligibility Criteria

Inclusion Criteria: 1. Target patients aged 18-75, including those aged 18 and 75 2. Primary IgA nephropathy diagnosed by renal biopsy within 3 months 3. eGFR≥30ml/min/1.73m2 4. 24-hour urine protein ≥ 1.0g/d, or UPCR ≥ 0.8 g/g 5. Sign informed consent Exclusion Criteria: 1. Including but not limited to secondary IgAN caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis 2. Patients who have received kidney transplantation or dialysis 3. Patients with other glomerular diseases (such as C3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria\>3.5 g/d, serum albumin\<3.0 g/dl, with or without edema) 4. Patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections 5. Patients with type 1 or type 2 diabetes diagnosed and poorly controlled (HbA1c\>8%) 6. Patients with a history of unstable

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