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

PHASE2CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

January 31, 2010

Conditions
End-Stage Renal Disease (ESRD)
Interventions
DEVICE

Standard Bicarbonate Solution

Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

DRUG

Soluble Ferric Pyrophosphate

Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

DRUG

Soluble Ferric Pyrophosphate

Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

DRUG

Soluble Ferric Pyrophosphate

Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

DRUG

Soluble Ferric Pyrophosphate

Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Trial Locations (28)

10013

Investigator, New York

11021

Investigator, Great Neck

11212

Investigator, Brooklyn

11385

Investigator, Ridgewood

11501

Investigator, Mineola

17033

Investigative Site, Hershey

22206

Investigator, Arlington

27103

Investigator, Winston-Salem

30901

Investigative Site, Augusta

44718

Investigative Site, Canton

45229

Investigator, Cincinnati

48202

Investigative Site, Detroit

60617

Investigator, Chicago

70115

Investigator, New Orleans

76011

Investigator, Arlington

76105

Investigator, Fort Worth

78207

Investigator, San Antonio

78503

Investigator, McAllen

83642

Investigator, Meridian

85284

Investigator, Tempe

90059

Investigator, Los Angeles

90603

Investigator, Whittier

91745

Investigator, Hacienda Heights

92133

Investigator, Seattle

40202-1718

Investigative Site, Louisville

01107

Investigator, Springfield

07601

Investigator, Hackensack

T6G2B7

Investigative Site, Edmonton

All Listed Sponsors
lead

Rockwell Medical Technologies, Inc.

INDUSTRY

NCT00548249 - Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis | Biotech Hunter | Biotech Hunter