Was the pharmacokinetics of icodextrin studied in special populations?
In the Phase 2 studies, the demographic distribution of female and male patients, as well as the patients of white, black and other races was balanced. Statistical analysis of the data from the study RD-97-CA-130 examined the effects of gender, study site, race, and diabetes on the treatment. Effects of race, diabetes, and site on the net ultrafiltration were marginal. Age category and gender effects were not significant. The influence of diabetes on urea nitrogen clearance and age on creatinine clearance were marginally significant (p#0.10). Statistical model input and output files were not available for review. The applicant did not attempt to evaluate statistically the influence of demographics as well as disease state, and diabetic status on the pharmacokinetics of icodextrin and/or its metabolites.
