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

Iron Deficiency Anemia Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223977
• Other study ID #: FR03001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: May 17, 2013
• Start date: December 2003
• Est. completion date: February 2008

Study information

• Verified date: May 2013
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 2008
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Sodium Ferric Gluconate Complex
125 mg weekly x 8 weeks
• Sodium Ferric Gluconate Complex
250 mg weekly x 4
• Oral Iron
325 mg ferrous sulfate orally three times daily x 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Croatia,  India,  Mexico,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection	Baseline to 5 weeks and 9 weeks	No
Secondary	Change From Baseline in Hematocrit (Hct)	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection	Baseline to 5 weeks and 9 weeks	No
Secondary	Change From Baseline in Transferrin Saturation (TSAT).	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection	Baseline to 5 weeks and 9 weeks	No
Secondary	Change From Baseline in Serum Ferritin.	Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection	Baseline to 5 weeks and 9 weeks	No
Secondary	Responders by Treatment Group	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.	Baseline to 5 weeks and 9 weeks	No