Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant
A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-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.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- The primary objective of this study is to evaluate the safety and efficacy of eculizumab in preventing AMR in positive crossmatch patients undergoing +XMatch LDKTx. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Eculizumab will be given on Day 0 (1 hour pre-transplant) then once a week for 4 weeks. Then on week 5, 7, and 9.
Other Name: Soliris
|Contact: Nong Yowe Braaten, LPNfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Nong Yowe Braaten, LPN 507-538-9617 email@example.com|
|Principal Investigator: Mark D. Stegall, M.D.|
|Principal Investigator:||Mark D. Stegall, M.D.||Mayo Clinic|