Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Ottawa Hospital Research Institute55 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anemia Renal Failure

Interventions

Heme Iron Polypeptide (Proferrin)DRUG

Heme iron polypeptide 11mg po tid for 6 months

Iron sucrose (Venofer)DRUG

Iron sucrose infusion IV q month x 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: 1. Iron overload (Tsat \> 50% or ferritin \> 800 μg/L); 2. malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months; 3. parenteral iron therapy, blood transfusion within the last 3 months; 4. pregnancy; 5. contraindication to any study medication and; 6. inability or refusal to give consent.

Locations (1)

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Hemoglobin Concentration at 6 Months

Time frame: 6 months

Secondary Outcomes

Ferritin

Comparison of Ferritin at 6 months between the 2 Groups

Time frame: 6 months

Transferrin Saturation

Comparison of Transferrin Saturation between the Groups

Time frame: 6 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.