Clinical trial NCT00224055: Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Hemoglobin (Hgb)
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Change in Serum Ferritin
timeFrame: Baseline to 10 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: San Diego
country: United States
state: California
city: Hines
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Birmingham
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charlotte
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Watson Laboratories, Inc.
name: Naomi Dahl, Pharm.D.
role: STUDY_DIRECTOR
References:
citation: 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.