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| Name | Class |
|---|---|
| Nanjing PLA General Hospital | OTHER |
| Beijing Children's Hospital | OTHER |
| Central South University | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine |
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This study tries to identify the safe and effective treatment option for IgA nephropathy in children. Investigators will perform prospective registration study among 25 pediatric nephrology medical centers in China.
A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide, according to the following protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| corticosteroid | pediatric IgA nephropathy treated with only corticosteroid |
| |
| corticosteroid and cyclophosphamide | pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide |
| |
| corticosteroid and mycophenolate mofetil | pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of proteinuria | Complete remission is defined as 24-hour urine protein<150mg or UPC<0.3 g/g with normal kidney function. Partial remission is defined as urine protein decreased by more than 50% with normal renal function. | Two years |
| Renal dysfunction | Renal dysfunction is defined as eGFR declined by more than 50%. | Two years |
| Hypertension | Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded. | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| End stage renal disease(ESRD) | ESRD is defined as eGFR<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant. | Two years |
| Mortality | Death of participants will be recorded. |
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In-patients will be enrolled with the following criteria.
Inclusion Criteria:
Exclusion Criteria:
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A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuhui Zhong, Dr. | Contact | 8613683556856 | xuhui7876@126.com | |
| Jie Ding, Prof. | Contact | 861083573238 | djnc_5855@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Ding, Prof. | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | 100034 | 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 |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D013256 | Steroids |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| C021988 | deflazacort |
| D003520 | Cyclophosphamide |
| D009173 | Mycophenolic Acid |
| D004176 | Dipyridamole |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D057911 | Angiotensin Receptor Antagonists |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Tongji Hospital | OTHER |
| Hunan Children's Hospital | OTHER_GOV |
| Shanghai Children's Hospital | OTHER |
| Nanjing Children's Hospital | OTHER |
| Children's Hospital of Chongqing Medical University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Fuzhou General Hospital | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Children's Hospital of Hebei Province | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
| Jiangxi Province Children's Hospital | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Xian Children's Hospital | OTHER_GOV |
| Capital Institute of Pediatrics, China | OTHER |
| The First Hospital of Jilin University | OTHER |
| Wuhan Women and Children's Medical Center | OTHER |
| Tianjin Children's Hospital | OTHER |
| Chengdu Women's and Children's Central Hospital | OTHER |
| The First People's Hospital of Yunnan | OTHER |
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The urine, serum and DNA of participants are expected to be collected and preserved.
| Cyclophosphamide | Drug |
|
|
| Mycophenolate mofetil | Drug |
|
|
| Dipyridamole | Drug |
|
| ACE Inhibitor or Angiotensin receptor antagonist | Drug |
|
| Two 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |