Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079788
Status:
RECRUITING
Last Update Posted:
2023-10-12
First Post:
2023-10-08
Brief Title:
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome a Prospective Multicenter RandomizedOpen-label Clinical Trial
Sponsor:
Mao Jianhua
Organization:
The Childrens Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome a Prospective Multicenter RandomizedOpen-label Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-10
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:
Primary nephrotic syndrome accounts for approximately 90 of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children Although treatment with steroids is useful for primary nephrotic syndrome proving to cause frequent relapsesteroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of such patients This study is a prospective multicenter randomizedopen-label clinical trial evaluating the efficacy and safety of steroid combined with adrenocorticotrophic hormoneACTH to children who with frequently relapsing or steroid-dependent nephrotic syndrome all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome
Detailed Description:
Although steroids are recognized as first-line treatments for nephrotic syndrome the vast majority of children relapse and about half of them have frequent relapse or steroids dependence after treatment with steroids alone Some children experienced steroids-resistance after multiple relapses and eventually developed into chronic kidney dysfunction Long-term or repeated application of large doses of steroids will lead to side effects such as obesity growth retardation and hypertension Although the treatment of steroids with immunosuppressive agents is a new choice for the treatment of such patients traditional immunosuppressive agents will bring some serious irreversible side effects
The clinical application of ACTH in children with nephrotic syndrome dates back to the late 1940s In recent years the new mechanism of action of ACTH is also being explored A number of clinical studies on the treatment of nephrotic syndrome by ACTH have found that it can still achieve good efficacy in patients who are ineffective in first-line treatment This study evaluated the efficacy of ACTH in the treatment of relapsing or steroid-dependent nephrotic syndrome in children in order to provide a more effective and safer treatment for children with nephrotic syndrome as well as the therapeutic medication options
The clinical application of ACTH in children with nephrotic syndrome dates back to the late 1940s In recent years the new mechanism of action of ACTH is also being explored A number of clinical studies on the treatment of nephrotic syndrome by ACTH have found that it can still achieve good efficacy in patients who are ineffective in first-line treatment This study evaluated the efficacy of ACTH in the treatment of relapsing or steroid-dependent nephrotic syndrome in children in order to provide a more effective and safer treatment for children with nephrotic syndrome as well as the therapeutic medication options
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