Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05782933
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2022-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
Sponsor:
Beijing Friendship Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Low Dose Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
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:
Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults.
Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.
Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.
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?: