Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
Organ transplantation offers the only hope for a normal life for patients with end-stage
renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies
to human leukocyte antigens (HLA), transplantation is extremely difficult or impossible since
pre-formed antibodies will cause severe rejection and loss of transplanted organs.
Approximately 30% of the transplant list in the U.S. is considered sensitized (have
detectable antibodies to HLA antigens). These anti-HLA (anti-Human Leukocyte Antigen
antibodies) pose a significant barrier to transplantation that has recently been successfully
addressed using desensitization therapies with IVIG, rituximab and/or plasmapheresis (PE).
Despite the success of these therapies, post-transplant antibody mediated rejection (AMR) and
chronic Antibody Mediated Rejection (CAMR) remain significant problems. Recent data suggests
that addition of Berinert (C1 Inhibitor) to post-transplant treatment regimen may
significantly reduce incidence of Antibody Mediation Rejection.
Twenty highly-sensitized patients who have undergone desensitization treatment and are
awaiting kidney transplant will be enrolled in the study. Once transplanted these patients
will be started on the standard of care post-transplant immunosuppressive protocol. In
addition patients will receive Berinert 20 units/ kg daily x 3 days, then twice weekly x 3
weeks. At the end of Berinert treatment a kidney biopsy will be performed. Subjects will be
followed for 6 months to assess safety and efficacy of the study protocol.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Stanley Jordan, MD
Collaborator:
CSL Behring
Treatments:
Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein Complement C1s