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Optimizing Protocol Design and Enhancing Patient Enrollment

An emerging biopharmaceutical company was considering development of a pharmacologic agent for treatment of patients with diabetic kidney disease (DKD). The company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria. They were uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid subject recruitment.