Overview

Ides in Highly Sensitized Patients Awaiting Kidney Transplantation

Status:
Completed
Trial end date:
2017-12-30
Target enrollment:
Participant gender:
Summary
IdeS® is an IgG-degrading enzyme of S.pyogenes that cleaves all four human subclasses of IgG with strict specificity. Alloantibodies are a major deterrent to access to and success of life-saving organ transplants. We hypothesize that the use of IdeS® pre-transplant in HS patients will represent a more robust and complete technique to eliminate DSA from the sera of HS patients. A single dose administration of IdeS® in the pre-operative period to HS patients with positive DSAs and flow cytometry crossmatches will durably eliminate circulating DSAs, allow transplantation to occur without ABMR and, in conjunction with standard desensitization therapy, result in a durable suppression of DSA levels thus eliminating the risk for ABMR.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Collaborators:
Hansa Biopharma AB
Hansa Medical AB
Treatments:
Antibodies