2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

Phase 2

Completed

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: Oral Iron; Drug: Sodium Ferric Gluconate Complex

• Registration Number: NCT00223977
• Lead Sponsor: Watson Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2008-02
• Results First Submitted: 2009-08-19
• Results First Submitted QC: 2009-08-19
• Results First Posted: 2009-09-28
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-17
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral iron	Oral Iron	325 mg ferrous sulfate three times daily x 8 weeks
Sodium ferric gluconate complex 125 mg	Sodium Ferric Gluconate Complex	125 mg sodium ferric gluconate weekly x 8 weeks
Sodium ferric gluconate complex 250 mg	Sodium Ferric Gluconate Complex	250 mg sodium ferric gluconate complex weekly x 4 weeks

Primary Outcome Measures

Name	Time	Method
Hemoglobin	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 Outcome Measures

Name	Time	Method
Change From Baseline in Transferrin Saturation (TSAT).	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
Change From Baseline in Hematocrit (Hct)	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
Change From Baseline in Serum Ferritin.	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
Responders by Treatment Group	Baseline to 5 weeks and 9 weeks	Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.