Completed

NCT Number: NCT00224042

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

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®.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Juan, Puerto Rico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Moderate to severe anemia
Iron deficiency
Moderate to severe chronic kidney disease
Receiving therapy with erythropoietic agent

Exclusion criteria

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

Treatment and study plan

sodium ferric gluconate complex in sucrose

Drug

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

Other names: Ferrlecit

Ferrous Sulfate tablets

Drug

ferrous sulfate 325 mg three times daily for 6 weeks

Primary outcomes

Baseline Hemoglobin Concentration

Time frame: Baseline
Change in Hemoglobin (Hgb)

Time frame: Baseline to 10 weeks

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.

Secondary outcomes

Baseline Serum Ferritin Concentration

Time frame: Baseline
Change in Serum Ferritin

Time frame: Baseline to 10 weeks

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.

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy

Important dates

Study start: 2003
Primary completion: 2005
First posted: Sep 22, 2005
Registry last updated: Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed