Determination of VIT 45 (IND#63,243 - American Regent) removal by closed loop in vitro hemodialysis system

Intravenous iron is typically administered during the hemodialysis (HD) procedure. The extent of VIT 45, a novel intravenous iron formulation, removal by high-flux (HF) or high-efficiency (HE) dialysis membranes at various ultrafiltration rates (UFR) is unknown.

An in vitro HD system was constructed to determine the dialyzability of iron from a normal saline compartment (NSC) containing 1000 mg iron of VIT 45. The in vitro system utilized a 6-L closed-loop SBS system that was subject to 4 different HD conditions conducted over 4 hours: HE membrane + 0 ml/h UFR; HE membrane + 500 ml/h UFR; HF membrane + 0 ml/h UFR; HF membrane + 500 ml/h UFR. Blood flow and dialysate flow rates were 500 ml/min and 800 ml/min, respectively. The dialysate compartment was a 6-L closed-loop system. A volumetric HD machine controlled all blood, dialysate, and ultrafiltration rates. NSC and dialysate compartment samples were taken at various time points and iron elimination rate (khd) and HD clearance (Clhd) was determined. Iron removal from the NSC > 15% was considered clinically significant.

The percent removal of iron from the NSC was < 0.5% at all time points in the study. Dialysate recovery of iron was negligible: 1.7-5.1 mg. VIT 45 removal elimination rates from NSC were less than -0.001 h(-1) (range -0.0002 +/- 0.0001 to -0.0001 +/- 0.0002 h (-1)) for all study conditions. Dialyzer type or UFR did not effect iron removal.

HF or HE dialysis membranes do not remove clinically significant amounts of VIT 45 over a 4-hour in vitro HD session. This effect remained constant even controlling for UFR up to 500 ml/hour. VIT 45 is not dialyzed by HE or HF dialysis membranes irrespective of UFR.