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.

Recognizing the Challenge

The sponsor’s initial draft protocol specified an estimated glomerular filtration rate (eGFR) of 30-59 ml/ min/1.73m2 and a urinary albuminto-creatinine ratio (UACR) greater than or equal to 300 mg/g. Although these protocol entry criteria were consistent with the presence of Stage 3 CKD and microalbuminuria, Covance was able to model this and see that rapid recruitment for the Phase II study could be difficult to achieve because of the low prevalence of patients with Type 2 Diabetes who would meet both of these specific criteria for eGFR and UACR.