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The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS | Active Comparator | low-dose corticosteroids monotherapy |
|
| CS+CTX | Active Comparator | low-dose corticosteroids combined with cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | RAS blockade as much as tolerated or allowed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Combined event | 40% decrease in eGFR, ESRD or death due to kidney disease | up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proteinuria remission at 6, 12 months and total follow-up period | Proteinuria remission | up to 6 years |
| Hematuria remission at 6, 12 months and total follow-up period | Hematuria remission |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AFMMU | Recruiting | Xi'an | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Prednisolone plus Cyclophosphamide |
| Drug |
RAS blockade as much as tolerated or allowed |
|
| up to 6 years |
| The composite of 30% decrease in eGFR, ESRD and all cause death | up to 6 years |
| The composite of 40% decrease in eGFR, ESRD and all cause death | up to 6 years |
| The composite of 50% decrease in eGFR, ESRD and all cause death | up to 6 years |
| Annual eGFR decline rate | up to 6 years |
| 30% decrease in eGFR | up to 6 years |
| 40% decrease in eGFR | up to 6 years |
| 50% decrease in eGFR | up to 6 years |
| ESRD | up to 6 years |
| All cause death | up to 6 years |
| 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |