Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130631
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-14
First Post:
2023-11-04
Brief Title:
Predictors of Steroid Response in Childhood Nephrotic Syndrome
Sponsor:
Maha Radwan
Organization:
Assiut University
Study Overview
Official Title:
Retrospective Study on Predictors of Steroid Response in Childhood Nephrotic Syndrome at Assiut University Children Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Retrospective study of predictors of steroid response in childhood nephrotic syndrom
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 12 and 169 cases per 100000 children with the highest incidence observed on the Indian subcontinent compared to 2-3 cases per 100000 children in most other regions Males appear to be more affected than females at a ratio of 21 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
The incidence worldwide varies widely between 12 and 169 cases per 100000 children with the highest incidence observed on the Indian subcontinent compared to 2-3 cases per 100000 children in most other regions Males appear to be more affected than females at a ratio of 21 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None