IgA Nephropathy, Proteinuria in Nephrotic Range, Immunosuppressive Treatment
Conditions
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.
Interventions
DRUGCorticosteroid
DRUGCyclophosphamide
DRUGMycophenolate mofetil
DRUGDipyridamole
Sponsors
Nanjing PLA General Hospital
Beijing Children's Hospital
Central South University
The Children's Hospital of Zhejiang University School of Medicine
First Affiliated Hospital, Sun Yat-Sen University
Tongji Hospital
Hunan Children's Hospital
Shanghai Children's Hospital
Nanjing Children's Hospital
Children's Hospital of Chongqing Medical University
Shandong Provincial Hospital
Fuzhou General Hospital
Second Affiliated Hospital of Wenzhou Medical University
Children's Hospital of Hebei Province
Guangzhou Women and Children's Medical Center
Jiangxi Province Children's Hospital
Guangzhou First People's Hospital
Xian Children's Hospital
Capital Institute of Pediatrics, China
The First Hospital of Jilin University
Wuhan Women and Children's Medical Center
Tianjin Children's Hospital
Chengdu Women's and Children's Central Hospital
The First People's Hospital of Yunnan
Peking University First Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Renal dysfunction | Two years | Renal dysfunction is defined as eGFR declined by more than 50%. |
| Hypertension | Two years | Hypertension is defined as blood pressure higher than age-specific average level. Use of antihypertensive drugs will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXuhui Zhong, Dr.
Backup ContactJie Ding, Prof.
Outcome results
None listed