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This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.
It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A 1-2-3Group | Experimental | Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. |
|
| B 1-3-5Group | Active Comparator | Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone(intravenously in the 1st-2nd-3rd month ) | Drug | Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission of proteinuria (complete or partial) | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation). | up to 6 months | |
| The longitudinal decline of kidney function(eGFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zongpei Jiang, M.D. & Ph.D. | Contact | 8620-38379727 | jx.home@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zongpei Jiang, M.D. & Ph.D. | The Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology,Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | 523059 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35062886 | Derived | Liang M, Xiong L, Li A, Zhou J, Huang Y, Huang M, Zhang X, Shi H, Su N, Wei Y, Jiang Z. The effectiveness and safety of corticosteroid therapy for IgA nephropathy with crescents: a prospective, randomized, controlled study. BMC Nephrol. 2022 Jan 21;23(1):40. doi: 10.1186/s12882-022-02661-6. |
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| Methylprednisolone(intravenously in the 1st-3rd-5th month) | Drug | Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. |
|
| up to 6 months |
| Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
|
| Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
|
| Department of Nephrology,Huizhou Municipal Central Hospital | Recruiting | Huizhou | Guangdong | 516001 | China |
|
| Department of Nephrology,1st Affiliated Hospital,Shenzhen University | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Department of Nephrology,1st People's Hospital of Zhaoqing | Recruiting | Zhaoqing | Guangdong | 526020 | China |
|
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D009336 | Necrosis |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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