Conditions: Anemia
Keywords: iron peritoneal dialysis anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

Detailed description:
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.

Arms:
arm 1: 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. arm 2: Stable erythropoietin (EPO) dose and no supplemental iron.

Interventions: intervention 1: Venofer and stable erythropoietin (EPO) regimen intervention 2: stable erythropoietin (EPO) regimen
Intervention descriptions: intervention 1: 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. intervention 2: Stable erythropoietin (EPO) dose and no supplemental iron.

Protocol document: