Open AccessDesign and conduct considerations for studies in patients with impaired renal function
Author(s) -
Ravenstijn Paulien,
Chetty Manoranjenni,
Manchandani Pooja
Publication year - 2021
Publication title -
clinical and translational science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.303
H-Index - 44
eISSN - 1752-8062
pISSN - 1752-8054
DOI - 10.1111/cts.13061
Subject(s) - impaired renal function , medicine , kidney disease , clinical trial , renal function , intensive care medicine , disease , drug , pharmacokinetics , population , pharmacology , environmental health
An impaired renal function, including acute and chronic kidney disease and end‐stage renal disease, can be the result of aging, certain disease conditions, the use of some medications, or as a result of smoking. In patients with renal impairment (RI), the pharmacokinetics (PKs) of drugs or drug metabolites may change and result in increased safety risks or decreased efficacy. In order to make specific dose recommendations in the label of drugs for patients with RI, a clinical trial may have to be conducted or, when not feasible, modeling and simulations approaches, such as population PK modeling or physiologically‐based PK modelling may be applied. This tutorial aims to provide an overview of the global regulatory landscape and a practical guidance for successfully designing and conducting clinical RI trials or, alternatively, on applying modeling and simulation tools to come to a dose recommendation for patients with RI in the most efficient manner.