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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
ChiCTR1800020121
Enrollment
Unknown
Registered
2018-12-15
Start date
2019-02-01
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Primary nephrotic syndrome in children

Interventions

Case series:Nil

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged from half to 18 years; (2) Primary nephrotic syndrome (PNS), the diagnostic criteria: massive proteinuria: 24-hour proteinuria quantification (> 50 mg/kg) or morning urine protein/creatinine (mg/mg) (> 2.0), urine protein qualitative (++-+++) three times a week; hypoproteinemia: serum albumin level was lower than that of serum albumin. 25 g/L; hyperlipidemia: serum cholesterol was higher than 5.7 mmol/L; edema of different degrees. Among the four items mentioned above, 1 and 2 were the necessary conditions for diagnosis; (3) no hormone or immunosuppressive treatment was given before inclusion in the cohort study with a clear and detailed history of drug treatment; (4) secondary nephrotic syndrome (allergic purpura, lupus, hepatitis B, diabetes mellitus, hereditary nephritis, severe infection, etc.) was excluded. Chronic kidney diseases caused by tumors, drugs and other factors.

Exclusion criteria

Exclusion criteria: 1. Exclude patients with obvious hormonal side effects, intolerance of hormones or hormonal contraindications; 2. Except for nephritic-nephrotic syndrome (NNS), which has one or more of the following four items: (1) three centrifugal uroscopy examinations of erythrocyte (> 10/HP) within two weeks and confirmed glomerulogenic hematuria; (2) repeated or persistent hypertension (> 3 collections measured at different time points) Systolic and/or diastolic blood pressures are greater than the 95th percentile of blood pressure in children and adolescents of the same sex, age and height, with the exception of glucocorticoids, etc.; (3) Renal dysfunction and exclusion of insufficient blood volume; (4) persistent hypocomplementemia.

Design outcomes

Primary

MeasureTime frame
Prognosis after 3 years (including clinical cure, complete remission, partial remission, no remission);Analysis of SSNS, SRNS and SDNS rates and their genetic background characteristics;

Secondary

MeasureTime frame
eGFR;Urine protein / creatinine;24-hour proteinuria/body weigh;Incidence of adverse events;

Countries

China

Contacts

Public ContactHaiping Yang

Children's Hospital of Chongqing Medical University

liqiu809@126.com+86 15215150041

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026