Chronic Kidney Disease Clinical Trial
Official title:
A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis
The purpose of the parent study is to assess the short-term safety and tolerability of
soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of
representative adult chronic kidney disease patients on hemodialysis (CKD-HD).
The purpose of the extension study is to assess the long-term safety and tolerability of
SFP.
Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients
were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate
concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week
washout, then crossed over to the alternate treatment x 2 weeks.
Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300
patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the
extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid
bicarbonate concentrate for up to 52 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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