Clinical trial NCT03015974: Registry of IgA Nephropathy in Chinese Children
Official title: Registry of IgA Nephropathy in Chinese Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgA Nephropathy
Proteinuria in Nephrotic Range
Immunosuppressive Treatment
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing PLA General Hospital
name: Beijing Children's Hospital
name: Central South University
name: The Children's Hospital of Zhejiang University School of Medicine
name: First Affiliated Hospital, Sun Yat-Sen University
name: Tongji Hospital
name: Hunan Children's Hospital
name: Shanghai Children's Hospital
name: Nanjing Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Shandong Provincial Hospital
name: Fuzhou General Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Children's Hospital of Hebei Province
name: Guangzhou Women and Children's Medical Center
name: Jiangxi Province Children's Hospital
name: Guangzhou First People's Hospital
name: Xian Children's Hospital
name: Capital Institute of Pediatrics, China
name: The First Hospital of Jilin University
name: Wuhan Women and Children's Medical Center
name: Tianjin Children's Hospital
name: Chengdu Women's and Children's Central Hospital
name: The First People's Hospital of Yunnan
First posted: 2017-01-10
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1200 patients diagnosed as primary IgA nephropathy with nephrotic proteinuria will be enrolled among 25 pediatric nephrology medical centers nationwide.

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.

Eligibility 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.

Primary outcomes:
measure: Improvement of proteinuria
timeFrame: Two years
measure: Renal dysfunction
timeFrame: Two years
measure: Hypertension
timeFrame: Two years
Secondary outcomes:
measure: End stage renal disease(ESRD)
timeFrame: Two years
measure: Mortality
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking University First Hospital
name: Jie Ding, Prof.
role: PRINCIPAL_INVESTIGATOR
References: