Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects. Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Official Title
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Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study

Conditions
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Anemia, Renal Failure

Intervention / Treatment
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* Drug: Heme Iron Polypeptide (Proferrin)
* Drug: Iron sucrose (Venofer)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: eGFR &lt; 30 mL/min Hb 90-110 g/L Age &gt; 18 Not on renal replacement therapy Transferrin saturation &lt; 20% OR Ferritin &lt;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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heme Iron<br>Heme Iron Polypeptide 11mg PO tid for 6 months | Drug: Heme Iron Polypeptide (Proferrin)<br>* Heme iron polypeptide 11mg po tid for 6 months<br>* Other names: Proferrin;|
| Active Comparator: Venofer<br>Venofer q month IV x 6 months | Drug: Iron sucrose (Venofer)<br>* Iron sucrose infusion IV q month x 6 months<br>* Other names: Venofer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Concentration at 6 Months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin | Comparison of Ferritin at 6 months between the 2 Groups | 6 months | 
| Transferrin Saturation | Comparison of Transferrin Saturation between the Groups | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial (RCT), Prospective Studies, ferric oxide, saccharated, Peptides, Heme, Iron, Erythropoietin,, Recombinant, Ferritin, Transferrin, Treatment Outcome