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

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ClinicalTrials.gov Identifier: NCT00236938
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : September 7, 2009
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Anemia Drug: Venofer and stable erythropoietin (EPO) regimen Drug: stable erythropoietin (EPO) regimen Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Study Start Date : July 2002
Actual Primary Completion Date : September 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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.
Other Name: Iron Sucrose
Active Comparator: Group B
Stable erythropoietin (EPO) dose and no supplemental iron.
 Drug: stable erythropoietin (EPO) regimen
Stable erythropoietin (EPO) dose and no supplemental iron.
Other Name: EPO


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change From Baseline to the Highest Hemoglobin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]

Secondary Outcome Measures :
  1. 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 ]
  2. The Mean Change From Baseline to the Highest Ferritin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]
  3. The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236938


Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Mark A Falone, MD Luitpold Pharmaceuticals
More Information
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Publications:

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00236938     History of Changes
Other Study ID Numbers: 1VEN02021 / 1VEN02022
First Posted: October 12, 2005    Key Record Dates
Results First Posted: September 7, 2009
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by Luitpold Pharmaceuticals:
iron
peritoneal dialysis
anemia

Additional relevant MeSH terms:
Iron
Ferric oxide, saccharated
Epoetin Alfa
Ferric Compounds
Trace Elements
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics