Chronic kidney disease (CKD) has been recognized as a leading public health problem worldwide. The global estimated prevalence of CKD is increasing. This increase is driven mainly by the increase in the prevalence of hypertension, obesity, diabetes mellitus, side effects from medications, and aging.
The kidneys, which are part of the urinary system, play an important role in filtering drugs and other compounds from the blood. Renal impairment occurs when the kidneys are not functioning properly which can range in severity from mild impairment to end stage renal disease.
Patients with CKD show a different pharmacokinetic in response to drugs that are mainly extracted via the kidneys. This can cause severe side effects and accumulation due to prolongation of the drug half-lifetime. A renal impairment clinical trial is required by the authorities for the dose adjustment in CKD patients in such cases.
There are many exceptions and increments to consider when planning the proper strategy for evaluating how renal impairment PK data should be collected. Information about regulatory requirements and reasonable design will help pharmaceutical companies to save time and money.
The goal of this webinar is to determine when a renal impairment clinical trial should be performed, and which approach is the best fit for different drugs.
Key Learning Objectives:
- Understanding rule of kidneys in drug extraction
- Understanding the authority requirements
- Understanding different design of renal impairment clinical studies
