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 : May 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia | Drug: Venofer and stable erythropoietin (EPO) regimen Drug: stable erythropoietin (EPO) regimen | Phase 3 |
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 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: stable erythropoietin (EPO) regimen
Stable erythropoietin (EPO) dose and no supplemental iron.
Other Name: EPO |
- Mean Change From Baseline to the Highest Hemoglobin up to Day 71 [ Time Frame: Change from Baseline up to Day 71 ]
- 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 ]

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

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
Study Director: | Mark A Falone, MD | American Regent, Inc. |
Responsible Party: | American Regent, Inc. |
ClinicalTrials.gov Identifier: | NCT00236938 |
Other Study ID Numbers: |
1VEN02021 / 1VEN02022 |
First Posted: | October 12, 2005 Key Record Dates |
Results First Posted: | September 7, 2009 |
Last Update Posted: | May 19, 2021 |
Last Verified: | April 2021 |
iron peritoneal dialysis anemia |
Anemia Hematologic Diseases Epoetin Alfa Ferric Oxide, Saccharated Hematinics |