Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318812
• Other study ID #: 2005840-01H
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 25, 2006
• Last updated: April 2, 2014
• Start date: May 2007
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Heme Iron Polypeptide (Proferrin)
Heme iron polypeptide 11mg po tid for 6 months
• Iron sucrose (Venofer)
Iron sucrose infusion IV q month x 6 months

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Concentration at 6 Months		6 months	No
Secondary	Ferritin	Comparison of Ferritin at 6 months between the 2 Groups	6 months	Yes
Secondary	Transferrin Saturation	Comparison of Transferrin Saturation between the Groups	6 Months	Yes