Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05588869
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2022-10-17
Brief Title:
Cyclosporine Adverse Outcomes in Steroid Dependent and Frequent Relapsing Nephrotic Syndrome in ChildrenSingle Center Study
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Cyclosporine Adverse Outcomes in Steroid Dependent and Frequent Relapsing Nephrotic Syndrome in ChildrenSingle Center Study
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
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:
Nephrotic syndrome NS is the most common glomerular disorder in children with significant morbidity and mortality and affects about 1-3 per 100000 children aged below 16 years Nephrotic syndrome is characterized by the presence of edema proteinuria uPCR urine protein creatinine ratio 200 mgmmol 2 gg or 3 protein on urine dipstick and hypoalbuminemia less than 3 gdlNephrotic syndrome is classified according to response to steroids into steroid sensitive and steroid resistant Approximately 90 of all cases are steroid-sensitive with an initial episode successfully treated with a standardized treatment protocol of steroids However about 80 of these patients experience further relapses Of these 50 are steroid dependent and frequent relapsers While any relapse can be treated with steroids children may be vulnerable to the side effects of a high cumulative dose of steroids such as obesity growth impairment behavioral alterations and attention problems as well as reduced quality of life and family stress To minimize steroid toxicity in patients with steroid-dependent and frequently relapsing nephrotic syndrome a number of immunosuppressive agents are recommended as maintenance therapeutic agents Among those are cyclosporine A tacrolimus mycophenolate mofetil MMF cyclophosphamide levamisole and rituximab Cyclosporin-A CsA is a calcineurin inhibitor that is well recognized as having a steroid sparing effect in steroid-dependent and frequently relapsing NS and has a role in the maintenance of complete remission in more than 75 of patients with SDNS during discontinuation of steroids However early withdrawl of cysclosporine may lead to relapses so the patient may be dependent on cyclosporine for years The long-term use of CsA has been identified to be a risk factor of unsatisfactory effects such as nephrotoxicity hypertension and cosmetic symptoms such as gum hypertrophy and hirsutism Therefore close observation of the side effects of cyclosporine is very important as well as regular follow up of blood pressure and kidney function tests Also estimation of trough blood levels of CsA is required in patients with suspected non compliance unsatisfactory response or nephrotoxicity increase in serum creatinine by 30 or more from the baseline aiming for the lowest levels that maintain remission and avoid toxicity target 12-hr trough level of 60-150 ngml Kidney biopsy could be included as a component of the long-term CsA protocol to test for CsA-associated nephropathy if given more than 2-3 years CsA nephrotoxicity is primarily caused by chronic ischemic insult to the kidney resulting in arteriolar hyalination and tubulointerstitial changes including striped interstitial fibrosis tubular vacuolization and atrophyThe aim of this study is to determine the adverse outcomes of Cyclosporine in children with steroid dependent and frequent relapsing nephrotic syndrome in Sohag University Hospital
Detailed Description:
None
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