Studies in early clinical development
4. Renal Impairment Study
The objective of renal impairment studies is to evaluate the medicine in people who have different levels of renal (kidney) function.
Renal impairment studies are typically run as single dose parallel group studies with healthy male and female volunteers (≥ 6 per group) who have varying degrees of renal function. The groups are stratified based on renal function biomarkers (Creatinine Clearance (CrCl)/Glomerular Filtration Rate (GFR)) in to groups for example: normal, mild, moderate, severe impairment, end stage renal disease (dialysis and non-dialysis).
The information gained from renal impairment studies: