Phase 3
N=121
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00236938 ↗Enrolled (actual)
121
Serious AEs
11.6%
Results posted
Sep 2009
Primary outcome: Primary: Mean Change From Baseline to the Highest Hemoglobin up to Day 71 — 1.3; .7 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Venofer and stable erythropoietin (EPO) regimen (Drug); stable erythropoietin (EPO) regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- American Regent, Inc.
- Primary completion
- Sep 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to the Highest Hemoglobin up to Day 71 |
1.3; .7 | — |
| SECONDARY The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 |
18.176; 10.383 | — |
| SECONDARY The Mean Change From Baseline to the Highest Ferritin up to Day 71 |
545.05; 70.523 | — |
| SECONDARY The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 |
0.7226; 0.4630 | — |
Summary
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00236938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.