Recruitment at a tearing pace in EMA compliant dose level study in subjects with reduced renal function

Mar 14, 2019

24 patients enrolled

In their function as the major filter and cleaning system of the blood, kidneys work in complex interaction with liver and gut during physiologic processes, including drug metabolisation and excretion. Reduced kidney function, often arising as a complication of type 2 diabetes, may hence directly impact drug safety and efficacy.

The key to a personalized dose-level approach in the treatment of type 2 diabetes of patients with reduced renal function, as emphasized in a recent European Medicines Agency (EMA) guideline (1), is the accurate and precise measurement of the renal function itself and its correlation with drug exposure. Renal function is usually assessed by the Glomerular Filtration Rate (GFR) and the EMA distinguishes between estimated GFR through endogenous markers and measured GFR through an exogenous substance, the latter being acknowledged as the gold standard.

In compliance with the EMA guidelines, the Charité Research Organisation provides the required technical expertise by measuring the renal clearance of iohexol after its application. Iohexol as an exogenous substance has the advantage of low extra-renal excretion and low protein binding, while it is furthermore neither secreted nor reabsorbed by the kidney, is considered non-toxic, and of low cost (2).

In an on-going study to test safety and pharmacokinetics of a new treatment, the Charité Research Organisation has successfully included the 24th patient within the first 3 months of the study. This was achieved even though inclusions were considered challenging as patients must be non-diabetic. The required pool was further dissected into cohorts with various stages of renal insufficiency. Thanks to its single-center and Germany-wide recruitment approach, the Charité Research Organisation is confident to include the remaining 24 patients during the next weeks, thereby shortening timelines, producing better data quality and reducing the overall study complexity.



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