Transplant Genomics® has announced that they have signed a laboratory services agreement with Astellas Pharma Global Development, Inc. Under terms of the agreement, Astellas will provide Transplant Genomics with funding and blood samples from renal transplant patients collected as part of a two year, prospective, randomized, multi-center clinical trial examining surrogate markers for long-term kidney transplant outcomes while comparing two immunosuppressive agents.
The primary outcome measure in the study is a composite endpoint combining the incidence of de novo donor specific antibodies (DSA) and molecular phenotyping using Transplant Genomics’ TruGraf™ test. Transplant Genomics will provide real-time molecular analysis of blood samples collected during the trial using TruGraf™, which will measure molecular signatures of immune activation in renal transplant patients.
“As Astellas is a worldwide leader in the development and commercialization of therapeutics for transplantation, we are excited to participate in this opportunity. TruGraf’s ability to measure subclinical acute rejection as well as clinical acute rejection will provide an enabling metric to compare immunosuppressive performance,” said Dr. Roy First, Chief Medical Officer, Transplant Genomics.
Astellas has designed a prospective, randomized, controlled clinical trial comparing two immunosuppressive agents, designed to detect a difference in surrogate markers of chronic immune-mediated graft loss: DSA and real-time molecular profiling (TruGraf) testing in peripheral blood samples from individual patients. These two components will be combined as part of a dual composite endpoint designed to test the hypothesis that the consistency of immunosuppression with Astagraf XL® decreases the development of DSA and reduces the molecular signature of immune activation.