Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

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

Sponsors

Lead Sponsor: Ottawa Hospital Research Institute

Source 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.

Overall Status Completed
Start Date May 2007
Completion Date December 2011
Primary Completion Date December 2011
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Hemoglobin Concentration at 6 Months 6 months
Secondary Outcome
Measure Time Frame
Ferritin 6 months
Transferrin Saturation 6 Months
Enrollment 55
Condition
Intervention

Intervention Type: Drug

Intervention Name: Heme Iron Polypeptide (Proferrin)

Description: Heme iron polypeptide 11mg po tid for 6 months

Arm Group Label: Heme Iron

Other Name: Proferrin

Intervention Type: Drug

Intervention Name: Iron sucrose (Venofer)

Description: Iron sucrose infusion IV q month x 6 months

Arm Group Label: Venofer

Other Name: Venofer

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Deborah Zimmerman, MD Principal Investigator Ottawa Hospital Research Institute
Location
Facility: The Ottawa Hospital Research Institute
Location Countries

Canada

Verification Date

April 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Heme Iron

Type: Experimental

Description: Heme Iron Polypeptide 11mg PO tid for 6 months

Label: Venofer

Type: Active Comparator

Description: Venofer q month IV x 6 months

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov