Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2004-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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.

Group Type EXPERIMENTAL

Venofer and stable erythropoietin (EPO) regimen

Intervention Type DRUG

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.

Group B

Stable erythropoietin (EPO) dose and no supplemental iron.

Group Type ACTIVE_COMPARATOR

stable erythropoietin (EPO) regimen

Intervention Type DRUG

Stable erythropoietin (EPO) dose and no supplemental iron.

Interventions

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Venofer and stable erythropoietin (EPO) regimen

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 Type DRUG

stable erythropoietin (EPO) regimen

Stable erythropoietin (EPO) dose and no supplemental iron.

Intervention Type DRUG

Other Intervention Names

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Iron Sucrose EPO

Eligibility Criteria

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Inclusion Criteria

* Hemoglobin \>= 9.5 and \<= 11.5 g/dL.
* Ferritin \<= 500 ng/ml.
* Serum Transferrin Saturation (TSAT) \<= 25%.
* Stable erythropoietin (EPO) Regimen for 8 weeks.
* No iron for last 4 weeks before randomization.

Exclusion Criteria

* Known Sensitivity to Iron Sucrose.
* Suffering concomitant severe diseases of the liver \& cardiovascular system.
* Pregnancy / Lactation.
* Inadequate dialysis.
* Current treatment for asthma.
* Significant blood loss.
* Probability of need for transfusion or transfusion within 1 week of enrollment.
* Anticipated major surgery.
* Hemochromatosis / hemosiderosis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No