Phase 3
Completed N=146
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
Source: ClinicalTrials.gov NCT00223977 ↗Enrolled (actual)
146
Serious AEs
15.8%
Results posted
Sep 2009
Primary outcomePrimary: Hemoglobin — 1.49; 0.89; 1.02 ng/mL
Summary
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin |
1.49; 0.89; 1.02 | — |
| SECONDARY Change From Baseline in Hematocrit (Hct) |
4.62; 2.93; 3.07 | — |
| SECONDARY Change From Baseline in Transferrin Saturation (TSAT). |
8.13; 8.2; 1.84 | — |
| SECONDARY Change From Baseline in Serum Ferritin. |
259.88; 368.67; 26.98 | — |
| SECONDARY Responders by Treatment Group |
30; 22; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, at least 18 years of age.
- Received maintenance peritoneal dialysis therapy for at least 4 weeks.
- Was expected to remain on peritoneal dialysis therapy for duration of study.
- Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
- Signed patient informed consent.
Exclusion Criteria
- Had a predetermined serum levels of Ferritin and TSAT
- Pregnant or lactating.
- Had a serious concomitant medical disorder incompatible with participation in the study.
- Had a known hypersensitivity to Ferrlecit or any of its components.
- Unable to cooperate or comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT00223977). 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.