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

NCT00224042 | Completed Phase 4 Results

• 1 other identifier: FER0201
• Study Type: interventional
• Target: 52
• 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 receiving erythropoietic agents, such as Procrit® and Aranesp®.

Conditions

Anemia, Iron-Deficiency; Kidney Failure, Chronic

Keywords

Iron deficiency; Anemia; Chronic kidney disease; Erythropoietic agents; Sodium Ferric Gluconate; Anemia, Iron-Deficiency/drug therapy/etiology; Kidney Failure, Chronic/blood/complications/therapy; Erythropoietin, Recombinant/adverse effects/therapeutic use

Outcome Measures

Primary Outcomes (2)

• Baseline Hemoglobin Concentration

  Baseline

• 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 (2)

• Baseline Serum Ferritin Concentration

  Baseline

• Change in Serum Ferritin

  Baseline to 10 weeks

Study Arms (2)

IV iron

EXPERIMENTAL

Drug: Sodium Ferric Gluconate complex in sucrose

oral iron

ACTIVE COMPARATOR

Drug: Ferrous sulfate tablets

Interventions

Sodium Ferric Gluconate complex in sucrose DRUG

Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses

Also known as: Ferrlecit

IV iron

Ferrous sulfate tablets DRUG

ferrous sulfate 325 mg 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
• Receiving therapy with erythropoietic agent

You may not qualify if:

• Receiving dialysis
• Known sensitivity to Ferrlecit® or any of its components
• Clinically unstable

Sponsors & Collaborators

• Watson Pharmaceuticals: lead

Study Sites (24)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Palo Alto, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Hines, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Springfield, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Detroit, New York, United States

Location

Unknown Facility

Mineola, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Charlotte, South Carolina, United States

Location

Unknown Facility

Chattanooga, Tennessee, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

San Juan, Puerto Rico

Location

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: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
• Organization: Watson Laboratories, Inc.

gary.hoel@watson.com

801-588-6641

Study Officials

• Adel R Rizkala, PharmD, MS

  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: May 1, 2005
• Last Updated: March 29, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-02

Locations

US (23); PR (1)