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Completed

NCT Number: NCT00318812

Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 7W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heme Iron Polypeptide (Proferrin)

Drug

Heme iron polypeptide 11mg po tid for 6 months

Other names: Proferrin

Iron Sucrose (Venofer)

Drug

Iron sucrose infusion IV q month x 6 months

Other names: Venofer

Primary outcomes

  1. Hemoglobin Concentration at 6 Months

    Time frame: 6 months

Secondary outcomes

  1. Ferritin

    Time frame: 6 months

    Comparison of Ferritin at 6 months between the 2 Groups

  2. Transferrin Saturation

    Time frame: 6 Months

    Comparison of Transferrin Saturation between the Groups

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2006
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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