An impaired renal function, including acute and chronic kidney disease and end-stage renal disease (ESRD), can be the result of ageing, certain disease conditions, the use of some medications or as a result of smoking. In patients with renal impairment (RI), the pharmacokinetics (PK) 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 RI patients, a clinical trial may have to be conducted or, when not feasible, modelling and simulations approaches such as population PK modelling (PopPK) or physiologically-based PK (PBPK) 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 modelling and simulation tools to come to a dose recommendation for RI patient in the most efficient manner.