Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis

Summary

The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.

Timeline

Start

2007-08

Primary completion

2009-10

Completion

2010-01

Outcome

Missed primary endpoint

registry analysis (unspecified test); 0 µg Iron/dL of Dialysate vs 5 µg Iron/dL of Dialysate; p = 0.999; Cox Proportional Hazard 1.00 (95% CI 0.30 to 3.32); Log Rank NCT00548249 ↗

Drugs

Indications