Phase 3
N=40
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
Anemia · Renal Failure
Bottom Line
View on ClinicalTrials.gov: NCT00318812 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Hemoglobin Concentration at 6 Months — 117; 113 g/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Heme Iron Polypeptide (Proferrin) (Drug); Iron sucrose (Venofer) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin Concentration at 6 Months |
117; 113 | — |
| SECONDARY Ferritin |
85.5; 244 | — |
| SECONDARY Transferrin Saturation |
21.5; 21.5 | — |
Summary
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
Eligibility Criteria
Inclusion Criteria
- eGFR < 30 mL/min
- Hb 90-110 g/L
- Age > 18
- Not on renal replacement therapy
- Transferrin saturation < 20% OR Ferritin <100 mcg/L
- B12 & folate within reference range
Exclusion Criteria
- Iron overload (Tsat > 50% or ferritin > 800 μg/L);
- malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
- parenteral iron therapy, blood transfusion within the last 3 months;
- pregnancy;
- contraindication to any study medication and;
- inability or refusal to give consent.
Data sourced from ClinicalTrials.gov (NCT00318812). 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.