Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

NCT00224055 | Completed Phase 4 Results

• 1 other identifier: FER0202
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 24

Brief Summary

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Conditions

Anemia, Iron-Deficiency; Kidney Failure, Chronic

Keywords

Iron deficiency; Anemia; Chronic kidney disease; Sodium Ferric Gluconate; Anemia, Iron-Deficiency/drug therapy/etiology; Kidney Failure, Chronic/blood/complications/therapy

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin (Hgb)

  Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.

  Baseline to 10 weeks

Secondary Outcomes (1)

• Change in Serum Ferritin

  Baseline to 10 weeks

Study Arms (2)

IV iron

EXPERIMENTAL

Sodium ferric gluconate

Drug: Sodium Ferric Gluconate Complex in Sucrose Injection

oral iron

ACTIVE COMPARATOR

ferrous sulfate

Drug: Ferrous sulfate tablets

Interventions

Sodium Ferric Gluconate Complex in Sucrose Injection DRUG

Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks

IV iron

Ferrous sulfate tablets DRUG

ferrous sulfate, 325 mg oral, three times daily for 6 weeks

oral iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe anemia
• Iron deficiency
• Moderate to severe chronic kidney disease

You may not qualify if:

• Receiving dialysis
• Known sensitivity to Ferrlecit® or any of its components
• Receiving therapy with erythropoietic agent
• Clinically unstable

Sponsors & Collaborators

• Watson Pharmaceuticals: lead

Study Sites (24)

Unknown Facility

Tucson, Arizona, United States

Location

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Los Angeles, California, United States

Location

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Palo Alto, California, United States

Location

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San Diego, California, United States

Location

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Hines, Illinois, United States

Location

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Indianapolis, Indiana, United States

Location

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Shreveport, Louisiana, United States

Location

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Baltimore, Maryland, United States

Location

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Springfield, Massachusetts, United States

Location

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Detroit, Michigan, United States

Location

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St Louis, Missouri, United States

Location

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Birmingham, New York, United States

Location

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Mineola, New York, United States

Location

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New York, New York, United States

Location

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The Bronx, New York, United States

Location

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Chapel Hill, North Carolina, United States

Location

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Cleveland, Ohio, United States

Location

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Philadelphia, Pennsylvania, United States

Location

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Charlotte, South Carolina, United States

Location

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Chattanooga, Tennessee, United States

Location

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Memphis, Tennessee, United States

Location

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Houston, Texas, United States

Location

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Fairfax, Virginia, United States

Location

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San Juan, Puerto Rico

Location

Related Publications (1)

• Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. doi: 10.1159/000096174. Epub 2006 Oct 11.

  PMID: 17035697 RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Kidney Failure, Chronic; Iron Deficiencies; Anemia; Renal Insufficiency, Chronic; Renal Insufficiency; Bronchiolitis Obliterans Syndrome

Interventions

ferric gluconate; Sucrose; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Coordination Complexes; Organic Chemicals; Dextrans; Glucans

Results Point of Contact

• Title: Naomi Dahl, PharmD Director, Clinical Affairs
• Organization: Watson Pharmaceuticals, Inc

Naomi.dahl@watson.com

Study Officials

• Naomi Dahl, Pharm.D.

  Watson Laboratories, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: March 29, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-02

Locations

US (23); PR (1)