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To observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary IgA nephropathy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gd-IgA1 test | Other | collect and test Gd-IgA1 test in enrolled subjects |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in proteinuria levels | To evaluate the changes in proteinuria levels of the target patient in the 12th month compared to baseline | about 12 months |
| Number of Participants With clinical significant Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. | Safety event | about 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the changes in eGFR of target patients at the 12th month compared to baseline | about 12 months | |
| Evaluate the changes in microscopic hematuria of the target patient at the 12th month compared to baseline | about 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the changes in GD-IgA1 levels of the target patient at 12 months compared to baseline. | about 12 months |
Inclusion Criteria:
Exclusion Criteria:
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Male or female, aged 18 to 75 years, diagnosed with primary IgA nephropathy through renal biopsy within 3 months, with eGFR ≥ 30ml/min/1.73m2, 24-hour urinary protein ≥ 1.0g/d, and blood pressure<140/90mmHg
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guisen Li, Doctor | Contact | +86-28-87393340 | guisenli@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
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UPCR, eGFR, blood chemistry, blood routine, urine routine, 24-hour Urine Protein Quantitation, etc..
| Assess the incidence of composite renal endpoint events (eGFR decreased by 40% from baseline or ESKD) in target patients | about 12 months |
| Assess the incidence of ESKD (eGFR<15ml/min/1.73m2) in target patients at the 12th month | about 12 months |
| Evaluate the proportion of target patients with a 40% decrease in eGFR compared to baseline at the 12th month | about 12 months |
| Evaluate the proportion of target patients whose average urinary protein level decreased by 50% from baseline in the 12th month | about 12 months |
| Evaluate the changes in serum and urine proteomics and metabolomics of the target patient in the 12th month | about 12 months |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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