This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
Stable erythropoietin (EPO) dose and no supplemental iron.
Mean Change From Baseline to the Highest Hemoglobin up to Day 71
Time frame: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
Time frame: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Ferritin up to Day 71
Time frame: Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
Time frame: Change from Baseline up to Day 71
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