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Relationships of clinical phenotypes and genetic background associated with immunogenology in primary childhood nephrotic syndrome: protocol for a prospective observational single center cohort study

Relationships of clinical phenotypes and genetic background associated with immunogenology in primary childhood nephrotic syndrome: protocol for a prospective observational single center cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019795
Enrollment
Unknown
Registered
2018-11-29
Start date
2019-02-01
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Nephrotic Syndrome

Interventions

Case series:NA

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Diagnostic criteria for primary nephrotic syndrome: massive proteinuria: 24-hour proteinuria (> 50mg/kg) or morning urine protein/creatinine (> 2.0 mg/mg) (++-++++++); hypoalbuminemia: serum albumin (> 25g/L); hyperlipidemia: serum cholesterol (> 5.7mmol/L); edema of varying degrees. 1 and 2 of the above 4 items are necessary conditions for diagnosis; 2. Henoch-Schonlein purpura (HSP) was diagnosed according to EULAR and Pres criteria in 2006. Contact (essential) rash with any of the following: 1) diffuse abdominal pain; 2) obvious IgA deposition on biopsy; 3) acute arthritis or arthralgia in any joint; 4) kidney Visceral damage is manifested as hematuria or proteinuria. Henoch-Schonlein purpura nephritis (HSPN) was established by the nephrology group of Chinese Medical Association in 2009, HSPN classification criteria and treatment guidelines (evidence-based guidelines for the diagnosis and treatment of HSPN (trial). The diagnostic criteria for HSPN were: hematuria and (or) proteinuria within 6 months of the course of HSP. The diagnostic criteria of hematuria and albuminuria: (1) hematuria: gross hematuria or microscopic hematuria, gross hematuria or microscopic hematuria three times a week. Red blood cells were more than 3 / high magnification (HP); (2) albuminuria: satisfy any of the following: 1) 3 times within a week urinary routine protein positive; 2) 24 hours urinary protein quantitative > 150 mg; 3 times within a week urinary microalbumin higher than normal value. In addition, HSPN should also be diagnosed in patients with recurrence of purpura, first hematuria and/or proteinuria after 6 months of HSP; 3. Outpatient health check-up children: in the study period and place, the included healthy children had no history of major diseases (except occasional upper respiratory tract infection), family members had no history of inbreeding, no family history of disease (strict identification of family history of kidney disease), the children and their parents had no abnormalities. SSNS: adequate prednisone 2 mg/(kg.d) or 60 mg/(m2. d), proteinuria remission after treatment 4 weeks exception of later SDNS/FRNS and secondary SRNS. SRNS: adequate prednisone treatment of proteinuria is still positive for 4 weeks or more, which is divided into initial SRNS and secondary SRNS, the latter is a corticosteroids therapy after 1 or more times to alleviate corticosteroids treatment > 4 weeks again the proteinuria is still positive. SDNS/FRNScorticosteroids sensitive, while two times reduction or withdrawal within 2 weeks and relapsed more than twice six monthsor relapsed more than quarter twelve months during the course of disease.

Exclusion criteria

Exclusion criteria: Exclude chronic kidney disease caused by factors such as secondary nephrotic syndrome (allergic purpura, lupus, hepatitis B, diabetes, hereditary nephritis, severe infection, tumor, and drugs); Excluding nephrotic-nephrotic syndrome, it has one or more of the following four items: 1. Three times of centrifugal microscopic examination of urine red blood cells within two weeks= 10/high power field (HP), and confirmed as glomerular hematuria; 2. Repeated or persistent hypertension = 3 times measured at different time points, the systolic blood pressure and/or diastolic blood pressure are (is) greater than the 95th percentile of blood pressure in children and adolescents of the same sex, age and height, except for glucocorticoids and other reasons; 3. Abnormal renal function, and ruled out due to insufficient blood volume; 4. Continuous hypocomplementemia.

Design outcomes

Primary

MeasureTime frame
Genetic variants;

Countries

China

Contacts

Public ContactHaiping Yang

Children's Hospital of Chongqing Medical University, Chongqing, People’s Republic of China

liqiu809@126.com+86 15215150041

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026