Predictors of Steroid Response in Childhood Nephrotic Syndrome

Nephrotic Syndrome in Children Clinical Trial

Official title:

Retrospective Study on Predictors of Steroid Response in Childhood Nephrotic Syndrome at Assiut University Children Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06130631
• Other study ID #: Steroid in nephrotic syndrome
• Status: Not yet recruiting
• Start date: December 3, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Maha Radwan Zaki, Doctor
• Phone: 01090963814
• Email: mahamai071[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective study of predictors of steroid response in childhood nephrotic syndrom

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 ).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 79
• Est. completion date: May 31, 2025
• Est. primary completion date: December 21, 2024
• Gender: All
• Age group: 12 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Nephrotic Syndrome in Children
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Maha Radwan	Assiut University

References & Publications (2)

Anochie I, Eke F, Okpere A. Childhood nephrotic syndrome: change in pattern and response to steroids. J Natl Med Assoc. 2006 Dec;98(12):1977-81. — View Citation

Sinha A, Bagga A. Nephrotic syndrome. Indian J Pediatr. 2012 Aug;79(8):1045-55. doi: 10.1007/s12098-012-0776-y. Epub 2012 May 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of steroid response in childhood nephrotic syndrom	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	2year