Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405100
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-04
Brief Title:
Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD
Sponsor:
Air Force Military Medical University China
Organization:
Air Force Military Medical University China
Study Overview
Official Title:
Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody Ripertamab in the Initial Treatment of Patients With Minimal Change Disease a Multi-center Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates lower recurrence rates and fewer side effects in patients with MCD
Detailed Description:
Minimal change disease is the third most common primary kidney disease in adults with idiopathic nephrotic syndrome The pathological features of the disease are no or only slight changes under light microscope and the foot process fusion under electron microscope The KDIGO guidelines recommend oral adequate doses of glucocorticoids as the initial treatment for adults with MCD However 48-76 of patients relapse after tapering or gradual discontinuation of the drug requiring a high cumulative dose of glucocorticoids As the cumulative dose of glucocorticoids increases the potential for side effects increases In addition 10 to 30 of patients frequently relapse and 15 to 30 of these are steroid dependent Therefore the clinical goals for patients with MCD are to achieve early remission of proteinuria reduce hormonal side effects and more importantly prevent the recurrence of proteinuria
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