drugset / Trial / NCT01322347

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)

NCT01322347

Phase 3 Completed 294 enrolled Rockwell Medical Technologies, Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

Timeline

Start
2011-04
Primary completion
2014-01
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Triferic Other / unclassified 11 ug Other