Predictors of Steroid Response in Childhood Nephrotic Syndrome

Sponsor
Maha Radwan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06130631
Collaborator
Assiut University (Other)
79
17.9

Study Details

Study Description

Brief Summary

Retrospective study of predictors of steroid response in childhood nephrotic syndrom

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Nephrotic syndrome is the most common glomerular disease affecting children worldwide ,Nephrotic syndrome is the combination of nephrotic-range proteinuria with a low serum albumin level and edema. Nephrotic-range proteinuria is the loss of 3 grams or more per day of protein into the urine or, on a single spot urine collection, the presence of 2 g of protein per gram of urine creatinine. Minimal change disease (MCD) or minimal change glomerulonephritis and focal segmental glomerulosclerosis (FSGS) are the two major causes of nephrotic syndrome in children and young adults, Idiopathic, hereditary, and secondary forms are due to underlying increased protein leakiness across the glomerular capillary wall, as a result of immune and non-immune insults affecting the podocyte.

    The incidence worldwide varies widely between 1.2 and 16.9 cases per 100,000 children with the highest incidence observed on the Indian subcontinent compared to 2-3 cases per 100,000 children in most other regions . Males appear to be more affected than females at a ratio of 2:1 at a younger age, but this predominance fails to persist in adolescence.

    treatment of nephrotic syndrome:- Corticosteroids have been used to treat childhood nephrotic syndrome since 1950 when large doses of adrenocorticotrophic hormone (ACTH) and cortisone given for two to three weeks were found to induce diuresis with loss of oedema and proteinuria. The response to treatment with steroids has been shown to vary by ethnicity, likely due to environmental and genetic factors. Corticosteroid usage has reduced the mortality rate in childhood nephrotic syndrome to around 3%, with infection remaining the most important cause of death. Of children who present with their first episode of nephrotic syndrome, approximately 80% will achieve remission with corticosteroid Prednisolone is the mainstay treatment, whose response is often presumed to determine the long-term risk of disease progression and is a better prognostic indicator . Although patients with steroid-sensitive nephrotic syndrome generally have good outcomes, more than half will have a frequently relapsing course and steroid dependence. Up to 95% of patients with minimal change nephrotic syndrome (MCNS) attain complete remission after an 8-week course of high dose steroids there are some factors affecting response to treatment with the steroids such as age of onset (the older the age of onset the better the response) ,gender (the females respond more to treatment) and type of nephrotic syndrome( minimal change glomerulonephritis responds more than focal segmental glomerulosclerosis to steroids ).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    79 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study on Predictors of Steroid Response in Childhood Nephrotic Syndrome at Assiut University Children Hospital
    Anticipated Study Start Date :
    Dec 3, 2023
    Anticipated Primary Completion Date :
    Dec 21, 2024
    Anticipated Study Completion Date :
    May 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Predictors of steroid response in childhood nephrotic syndrom [2year]

      Retrospective study of predictors of steroid response in childhood nephrotic syndrom Sach as hypertension, hematuria,raised renal chemistry in pediatric nephrology unit and outpatient outpatient nephrology clinic at assiut university children hospital

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • all children from 1 year to 18 years treated with steroid for nephrotic syndrom
    Exclusion Criteria:
    • children with other kideny disease Children less than 1 year old Children with secondary nephrotic syndrom

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Maha Radwan
    • Assiut University

    Investigators

    • Principal Investigator: Maha Radwan Zaki, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Maha Radwan, 71515, Assuit, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06130631
    Other Study ID Numbers:
    • Steroid in nephrotic syndrome
    First Posted:
    Nov 14, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023