Ignite Creation Date:
2024-05-05 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00670774
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2008-04-28
Brief Title:
Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant
Sponsor:
Mark Stegall
Organization:
Mayo Clinic
Study Overview
Official Title:
A Single Center Open-label Study to Determine the Safety and Efficacy of a Dosing Regimen of Eculizumab Added to Conventional Treatment in the Prevention of Antibody-mediated Rejection AMR in Positive Crossmatch Living Donor Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2018-05
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:
A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen HLA antibody never were able to receive a kidney transplant Over the past decade significant progress has been made in overcoming early antibody-mediated renal allograft injury Our group has performed more than 200 such transplants providing the possibility of transplant to previously untransplantable patients Despite our best efforts transplantation in these patients is still complicated by a high rate of acute humoral rejection AHR
Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody
Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody
Detailed Description:
The eculizumab dosing regimen was modified from that used in the treatment of paroxysmal nocturnal hemoglobinuria and consisted of 1200 mg immediately prior to transplantation 600 mg on postoperative day 1 and 600 mg weekly thereafter for 4 weeks At week 4 assessment of DSA levels was performed Eculizumab was discontinued in patients whose DSA had significantly decreased B flow crossmatch channel shift200 In patients with persistently high DSA and thus believed to have continued high risk for AMR eculizumab treatment continued 1200 mg week 5 and then every 2 weeks Another DSA assessment was performed at week 9 and eculizumab was discontinued if the B flow crossmatch channel shift was 200
The eculizumab group were compared to a historical control group consisting of consecutive transplants between 112005 and 1102017 who met the inclusion criteria The historical control group had been treated with a similar plasma exchange based protocol without eculizumab
The eculizumab group were compared to a historical control group consisting of consecutive transplants between 112005 and 1102017 who met the inclusion criteria The historical control group had been treated with a similar plasma exchange based protocol without eculizumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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