Phase 3
Completed N=182
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Source: ClinicalTrials.gov NCT00236977 ↗Enrolled (actual)
182
Serious AEs
8.8%
Results posted
Mar 2010
Primary outcomePrimary: Patients With an Increase in Hemoglobin >= 1gm/dL. — 35; 23 participants
Summary
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With an Increase in Hemoglobin >= 1gm/dL. |
35; 23 | — |
| SECONDARY Number of Subjects With a Clinical Response |
31; 1 | — |
| SECONDARY Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 |
1.1; .8 | — |
| SECONDARY Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 |
391.7; 45 | — |
| SECONDARY Mean Change in Ferritin (ng/mL) From Baseline to Day 56 |
230; 30 | — |
| SECONDARY Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 |
8.5; 5.5 | — |
| SECONDARY Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 |
.7; .3 | — |
Eligibility Criteria
Inclusion Criteria
- Hemoglobin < or = 11.5 gm/dL
- Stable dose or not receiving EPO
- Renal Anemia
Exclusion Criteria
- IV iron with last 6 months
- Chronic infection, malignancy,major surgery within last month
- Blood Transfusion with last two months
- Significant blood loss within last 3 months
- Concomitant sever diseases of the liver
Data sourced from ClinicalTrials.gov (NCT00236977). 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. Informational only — not medical advice.