Status:
COMPLETED
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00236938
Start Date
July 1 2002
End Date
October 1 2004
Last Update
May 19 2021
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