A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.

Watson Pharmaceuticals0 sites146 target enrollmentDecember 2003

ConditionsIron Deficiency Anemia

InterventionsSodium Ferric Gluconate Complex Oral Iron

DrugsSodium Ferric Gluconate Complex Oral Iron

Overview

Phase: Phase 2
Intervention: Sodium Ferric Gluconate Complex
Conditions: Iron Deficiency Anemia
Sponsor: Watson Pharmaceuticals
Enrollment: 146
Primary Endpoint: Hemoglobin
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

February 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Watson Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, at least 18 years of age.
•Received maintenance peritoneal dialysis therapy for at least 4 weeks.
•Was expected to remain on peritoneal dialysis therapy for duration of study.
•Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
•Signed patient informed consent.

Exclusion Criteria

•Had a predetermined serum levels of Ferritin and TSAT
•Pregnant or lactating.
•Had a serious concomitant medical disorder incompatible with participation in the study.
•Had a known hypersensitivity to Ferrlecit or any of its components.
•Unable to cooperate or comply with the protocol.

Arms & Interventions

Sodium ferric gluconate complex 125 mg

125 mg sodium ferric gluconate weekly x 8 weeks

Intervention: Sodium Ferric Gluconate Complex

Sodium ferric gluconate complex 250 mg

250 mg sodium ferric gluconate complex weekly x 4 weeks

Intervention: Sodium Ferric Gluconate Complex

Oral iron

325 mg ferrous sulfate three times daily x 8 weeks

Intervention: Oral Iron

Outcomes

Primary Outcomes

Hemoglobin

Time Frame: Baseline to 5 weeks and 9 weeks

Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection

Secondary Outcomes

Change From Baseline in Transferrin Saturation (TSAT).(Baseline to 5 weeks and 9 weeks)
Change From Baseline in Hematocrit (Hct)(Baseline to 5 weeks and 9 weeks)
Change From Baseline in Serum Ferritin.(Baseline to 5 weeks and 9 weeks)
Responders by Treatment Group(Baseline to 5 weeks and 9 weeks)