Predictors of Steroid Response in Childhood Nephrotic Syndrome

NCT ID: NCT06130631

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-03
• Study Completion Date: 2025-05-31

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 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 ).

Conditions

Nephrotic Syndrome in Children

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: collaborator

Maha Radwan

OTHER

Sponsor Role: lead

Responsible Party

Maha Radwan

71515, Assuit

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maha Radwan Zaki

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Maha Radwan Zaki, Doctor

Role: CONTACT

mahamai071@gmail.com

01090963814

Asmaa Mahmoud M. Ahmed, Clinical professor

Role: CONTACT

asmaa_ahmed@aun.edu.eg

01007041245

References

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.

Reference Type: BACKGROUND

PMID: 17225845 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22644544 (View on PubMed)

Other Identifiers

Steroid in nephrotic syndrome

Identifier Type: -

Identifier Source: org_study_id