Registry of IgA Nephropathy in Chinese Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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, according to the following protocol. Establishment of registration database online. Participants will be enrolled according to the inclusion criteria and exclusion criteria. The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up. SPSS software (version 14.0; SPSS, Inc., Chicago, IL, USA) will be used for statistical analysis. P value less than 0.05 will be considered significant.

Official Title
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Registry of IgA Nephropathy in Chinese Children

Conditions
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IgA Nephropathy, Proteinuria in Nephrotic Range, Immunosuppressive Treatment

Intervention / Treatment
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* Drug: Corticosteroid
* Drug: Cyclophosphamide
* Drug: Mycophenolate mofetil
* Drug: Dipyridamole
* Drug: ACE Inhibitor or Angiotensin receptor antagonist


Participation Criteria
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Eligibility Criteria
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In-patients will be enrolled with the following criteria. Inclusion Criteria: Clinical diagnosis of primary IgA nephropathy. Presenting with nephrotic proteinuria, defined as 24-hour urinary protein>50mg/kg, or UPC>2.0 mg/mg. Informed consent must be signed. Exclusion Criteria: Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| corticosteroid<br>pediatric IgA nephropathy treated with only corticosteroid | Drug: Corticosteroid<br> <br> * Other names: Deflazacort;Drug: Dipyridamole<br> <br> Drug: ACE Inhibitor or Angiotensin receptor antagonist<br> <br> |
| corticosteroid and cyclophosphamide<br>pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide | Drug: Corticosteroid<br> <br> * Other names: Deflazacort;Drug: Cyclophosphamide<br> <br> * Other names: CTX;Drug: Dipyridamole<br> <br> Drug: ACE Inhibitor or Angiotensin receptor antagonist<br> <br> |
| corticosteroid and mycophenolate mofetil<br>pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil | Drug: Corticosteroid<br> <br> * Other names: Deflazacort;Drug: Mycophenolate mofetil<br> <br> * Other names: MMF;Drug: Dipyridamole<br> <br> Drug: ACE Inhibitor or Angiotensin receptor antagonist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Two years |