The staff of CPMI has maintained a population of patients with Renal Impairment for a number of years. The size of this population averages between 50 -60 patients at any given time. Most of these patients result from our intensive screening programs and are classified as either mild (GFR 50-80 ml/min) or moderately (GFR 20-50 ml/min} impaired. Our ability to recruit severely impaired patients (GFR less than 30 ml/min) is limited by the fact that most of these subjects go on a transplant list and are placed on dialysis in our community but we still have been able to identify and study enough of these subjects every year to complete a number of FDA mandated studies according to the guidance that they have published. Studies with ESRD patients requires collaboration with a dialysis center or other investigator.
Guidance for Industry
Pharmacokinetics in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and labeling 1998 US Food and Drug Administration