Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation

Status Completed

Clinical Trial Summary

This is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation. We hope that IdeS® will help eliminate DSAs in HS patients who are DSA+ and flow cytometry (FCMX) crossmatch + at time of transplant. We plan to enroll a total of 20 patients. Patients will be followed for 6 months post administration of IdeS®.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02426684
Study type	Interventional
Source	Cedars-Sinai Medical Center
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	June 16, 2015
Completion date	November 10, 2017

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