Clinical trial NCT00223977: 2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
Official title: A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Iron Deficiency Anemia
Keywords: Anemia.
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 146
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 is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age.
* Received maintenance peritoneal dialysis therapy for at least 4 weeks.
* Was expected to remain on peritoneal dialysis therapy for duration of study.
* Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
* Signed patient informed consent.

Exclusion Criteria:

* Had a predetermined serum levels of Ferritin and TSAT
* Pregnant or lactating.
* Had a serious concomitant medical disorder incompatible with participation in the study.
* Had a known hypersensitivity to Ferrlecit or any of its components.
* Unable to cooperate or comply with the protocol.

Primary outcomes:
measure: Hemoglobin
timeFrame: Baseline to 5 weeks and 9 weeks
Secondary outcomes:
measure: Change From Baseline in Hematocrit (Hct)
timeFrame: Baseline to 5 weeks and 9 weeks
measure: Change From Baseline in Transferrin Saturation (TSAT).
timeFrame: Baseline to 5 weeks and 9 weeks
measure: Change From Baseline in Serum Ferritin.
timeFrame: Baseline to 5 weeks and 9 weeks
measure: Responders by Treatment Group
timeFrame: Baseline to 5 weeks and 9 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Torrance
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Evanston
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Winston-salem
country: United States
state: North Carolina
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Dallas
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Kelowna
country: Canada
city: Kitchener
country: Canada
city: London
country: Canada
city: Scarborough
country: Canada
city: Toronto
country: Canada
city: Zagreb
country: Croatia
city: Bangalore
country: India
city: Chandigarh
country: India
city: Chennai
country: India
city: Hyderabad
country: India
city: Lucknow
country: India
city: Mahim
country: India
city: New Delhi
country: India
city: Col. Toriello Guerra
country: Mexico
city: Durango
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Tlalpan
country: Mexico
city: Zapopan
country: Mexico
city: Osijek
country: Poland
city: Moscow
country: Russian Federation
city: St. Petersburg
country: Russian Federation
Study officials:
affiliation: Watson Pharmaceuticals
name: Gary Hoel, RPh, PhD
role: STUDY_CHAIR
References: