Was it correlated to the dose and/or concentration of the drug (Pharmacodynamics)?
A classical PK/PD study for Extraneal was not performed. The effect of the PD solution is measured by its ultrafiltration. Icodextrin is administered as 7.5% solution. The relationship between icodextrin and/or its metabolites concentrations in plasma, urine or spent dialysate were not established. However, clinical studies of chronic administration of Icodextrin showed a superior ultrafiltration compared to the exchange with 2.5% dextrose. An adequate exposure-response or dose-response relationship could not be established due to the fact that the sponsor did not conduct dose ranging studies of icodextrin and that in all the studies the same concentration of icodextrin solution was used. What was the exposure of icodextrin and its metabolites at the steady state? Icodextrin and its metabolite concentrations were measured in plasma at steady state in several multiple doses studies; however, due to the problems with the assay, only results of three of them: RD-97-CA-130, RD-97-CA-131, a
