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Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
This study has been completed.
Sponsor:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00236938
First received: October 10, 2005
Last updated: May 11, 2015
Last verified: May 2015
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Purpose
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
| Condition | Intervention | Phase |
|---|---|---|
| Anemia | Drug: Venofer and stable erythropoietin (EPO) regimen Drug: stable erythropoietin (EPO) regimen | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Luitpold Pharmaceuticals:
Primary Outcome Measures:
- Mean Change From Baseline to the Highest Hemoglobin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 121 |
| Study Start Date: | July 2002 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00236938
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236938
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
| Study Director: | Antoinette Mangione, MD, PharmD | Luitpold Pharmaceuticals |
More Information
Publications:
| Responsible Party: | Luitpold Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00236938 History of Changes |
| Other Study ID Numbers: |
1VEN02021 / 1VEN02022 |
| Study First Received: | October 10, 2005 |
| Results First Received: | January 14, 2009 |
| Last Updated: | May 11, 2015 |
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 |
ClinicalTrials.gov processed this record on September 19, 2017