NEW YORK (GenomeWeb) – Transplant Genomics (TGI) announced today that it has signed an agreement under which it will use its TruGraf post-kidney transplant blood test to evaluate renal transplant patient outcomes as part of a clinical trial being run by Astellas Pharma Global Development.
The two-year prospective, multi-center study is examining surrogate markers for long-term kidney outcomes — de novo donor-specific antibody (DSA) formation or a peripheral blood molecular phenotype of immune activation identified using the TruGraf test — in patients treated with either an immediate-release version of the immunosuppressive tacrolimus or Astellas's Astagraf XL (extended-release tacrolimus capsules).
These two markers will be combined as part of a dual composite endpoint to test the hypothesis that the consistency of immunosuppression with Astagraf XL decreases the development DSAs and lowers the molecular signature of immune activation, according to TGI.
TGI said Astellas will provide it with unspecified funding and blood samples from study participants for testing. Additional terms of the arrangement were not disclosed.
The deal with Astellas follows a similar agreement TGI signed last month to use TruGraf to evaluate patients in a Phase III trial of Quark Pharmaceuticals' RNAi-based treatment for delayed graft function QPI-1002.