Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation
Sponsor:
Tao Lin
Organization:
West China Hospital
Study Overview
Official Title:
A Single Center Open-label Single-arm Study to Determine the Safety and Efficacy of a Single Dosing Regimen Eculizumab for Prevention of Antibody-Mediated Rejection AMR in ABO Blood Group Incompatible Living Donor Kidney Transplantation ABOi-LDKTx
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors
Detailed Description:
Kidney transplantation is considered the best therapy for patients with end-stage renal disease ABO-incompatible living donor kidney transplantation ABOi-LDKTx is one of the strategies to expand the pool of donors However the blood group antibodies in recipients can lead to acute rejection resulting in transplant failure Before transplantation the use of rituximab RTX to remove B cells plasmapheresis to eliminate blood group antibodies can mitigate the occurrence of acute rejection and enhance the success rate of transplantation
The complement system plays a vital role in antibody-mediated rejection AMR Eculizumab can target the C5 protein of the complement system and then block the activation Therefore we hypothesize that the pretransplant use of eculizumab may prevent the AMR in ABOi-LDKTx
The complement system plays a vital role in antibody-mediated rejection AMR Eculizumab can target the C5 protein of the complement system and then block the activation Therefore we hypothesize that the pretransplant use of eculizumab may prevent the AMR in ABOi-LDKTx
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