Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

Phase 2

Completed

• Conditions: Anemia; Renal Failure
• Interventions: Drug: Heme Iron Polypeptide (Proferrin); Drug: Iron sucrose (Venofer)

• Registration Number: NCT00318812
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-27
• Study Start: 2007-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-06-26
• Results First Submitted QC: 2014-04-02
• Results First Posted: 2014-05-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heme Iron	Heme Iron Polypeptide (Proferrin)	Heme Iron Polypeptide 11mg PO tid for 6 months
Venofer	Iron sucrose (Venofer)	Venofer q month IV x 6 months

Primary Outcome Measures

Name	Time	Method
Hemoglobin Concentration at 6 Months	6 months

Secondary Outcome Measures

Name	Time	Method
Transferrin Saturation	6 Months	Comparison of Transferrin Saturation between the Groups
Ferritin	6 months	Comparison of Ferritin at 6 months between the 2 Groups

Trial Locations

Locations (1)

The Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada