Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614985
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-30
Brief Title:
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEST-T-PMN
Brief Summary:
This is a multiple-center prospective open-label positive drug controlled randomized clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy
Detailed Description:
The study consists of four stages as follows
1 Screening period 0-6 months After signing the informed consent form subjects enter the screening period
2 Induction treatment period 3 months Eligible subjects receive induction treatment with Methylprednisone 05 g i v for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 08 mgkgday tapered gradually after 2 months reduced by 5 mg every 2 weeks and cyclophosphamide is administrated intravenously at a dose of 04 gd twice a month
3 Group treatment period 6 months Patients who complete the induction treatment period undergo an efficacy assessment to determine whether they achieve a complete remission or partial remission Patients who do not achieve a complete remission or partial remission are defined as non-responders Patients who achieve a complete remission or partial remission are randomized and enter the group A or group B Patients of non-responders are randomized and enter the group C and group D Patients in group A and C continue the initial treatment regimen for 6 months Patients in group B and D commence hypodermic injection of Telitacicept 160 mg weekly 6 months with the continued administration of prednisone and cyclophosphamide in group D while discontinued cyclophosphamide administration in group B
4 Follow-up period 12 months After completing 6 months of group treatment cyclophosphamide or Telitacicept is discontinued with minimal dose of 5mgd prednisone remained All the patients are subjected to a 12-month follow-up
1 Screening period 0-6 months After signing the informed consent form subjects enter the screening period
2 Induction treatment period 3 months Eligible subjects receive induction treatment with Methylprednisone 05 g i v for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 08 mgkgday tapered gradually after 2 months reduced by 5 mg every 2 weeks and cyclophosphamide is administrated intravenously at a dose of 04 gd twice a month
3 Group treatment period 6 months Patients who complete the induction treatment period undergo an efficacy assessment to determine whether they achieve a complete remission or partial remission Patients who do not achieve a complete remission or partial remission are defined as non-responders Patients who achieve a complete remission or partial remission are randomized and enter the group A or group B Patients of non-responders are randomized and enter the group C and group D Patients in group A and C continue the initial treatment regimen for 6 months Patients in group B and D commence hypodermic injection of Telitacicept 160 mg weekly 6 months with the continued administration of prednisone and cyclophosphamide in group D while discontinued cyclophosphamide administration in group B
4 Follow-up period 12 months After completing 6 months of group treatment cyclophosphamide or Telitacicept is discontinued with minimal dose of 5mgd prednisone remained All the patients are subjected to a 12-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None