Registry of IgA Nephropathy in Chinese Children
- Conditions
- IgA NephropathyProteinuria in Nephrotic RangeImmunosuppressive Treatment
- Interventions
- Drug: CorticosteroidDrug: ACE Inhibitor or Angiotensin receptor antagonist
- Registration Number
- NCT03015974
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
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
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.
1. Establishment of registration database online.
2. Participants will be enrolled according to the inclusion criteria and exclusion criteria.
3. The following data will be collected prospectively, including demographic data, clinical symptoms, physical examination, laboratory examination, renal pathology, treatment protocol and follow-up.
4. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- 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.
- Diagnosed as secondary renal diseases, including lupus nephritis, purpura nephritis, hepatitis B virus associated nephritis, etc.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description corticosteroid and mycophenolate mofetil Mycophenolate mofetil pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil corticosteroid and mycophenolate mofetil ACE Inhibitor or Angiotensin receptor antagonist pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil corticosteroid and cyclophosphamide ACE Inhibitor or Angiotensin receptor antagonist pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide corticosteroid and cyclophosphamide Corticosteroid pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide corticosteroid Corticosteroid pediatric IgA nephropathy treated with only corticosteroid corticosteroid ACE Inhibitor or Angiotensin receptor antagonist pediatric IgA nephropathy treated with only corticosteroid corticosteroid and mycophenolate mofetil Corticosteroid pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil corticosteroid Dipyridamole pediatric IgA nephropathy treated with only corticosteroid corticosteroid and cyclophosphamide Cyclophosphamide pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide corticosteroid and cyclophosphamide Dipyridamole pediatric IgA nephropathy treated with corticosteroid and cyclophosphamide corticosteroid and mycophenolate mofetil Dipyridamole pediatric IgA nephropathy treated with corticosteroid and mycophenolate mofetil
- Primary Outcome Measures
Name Time Method Improvement of proteinuria Two years 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.
Hypertension Two years Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded.
Renal dysfunction Two years Renal dysfunction is defined as eGFR declined by more than 50%.
- Secondary Outcome Measures
Name Time Method End stage renal disease(ESRD) Two years ESRD is defined as eGFR\<15ml/min/1.73m2, initiation of long-term dialysis or kidney transplant.
Mortality Two years Death of participants will be recorded.
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, China