Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation

Project: Research project

Project Details

Description

The primary objective is to compare the incidence of a two-part composite endpoint consisting of de novo DSA formation or a designation of “immune activation (IA)” on peripheral blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.

Clinical Laboratory Services. Laboratory shall:
(a) perform all laboratory tests and procedures related to the systems, processes, and methods required for the measurement and evaluation of naturally occurring chemical substances in any Specimens in accordance with the requirements set forth in the Protocol and/or analytical methodology approved or provided by ASTELLAS. Such laboratory tests and procedures shall include, but not be limited to, evaluation of hematology (CBC), clinical chemistry (e.g., SMAC panel serum glucose, blood electrolytes), urinalysis, and non-blood supply fluid and tissue biopsy Specimen(s). The estimated quantity of such testing, based on the estimated number of Subjects enrolled in the Study, will be set forth in Exhibit B or specified by ASTELLAS;
StatusFinished
Effective start/end date7/31/163/31/20

Funding

  • Astellas Pharma Global Development, Inc. (Agmt 7/31/16)

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