Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Anemia; Renal Failure

Treatments: Drug: Iron sucrose (Venofer); Drug: Heme Iron Polypeptide (Proferrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00318812

2005840-01H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Heme Iron

Experimental group

Description:

Heme Iron Polypeptide 11mg PO tid for 6 months

Treatment:

Drug: Heme Iron Polypeptide (Proferrin)

Venofer

Active Comparator group

Description:

Venofer q month IV x 6 months

Treatment:

Drug: Iron sucrose (Venofer)