Clinical trial NCT00224042: Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
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 Being Treated With Erythropoietic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 52
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 receiving erythropoietic agents, such as Procrit® and Aranesp®.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline Hemoglobin Concentration
timeFrame: Baseline
measure: Change in Hemoglobin (Hgb)
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Baseline Serum Ferritin Concentration
timeFrame: Baseline
measure: Change in Serum Ferritin
timeFrame: Baseline to 10 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
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: St. Louis
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Detroit
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: Adel R Rizkala, PharmD, MS
role: STUDY_DIRECTOR
References: