Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
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ClinicalTrials.gov Identifier: NCT00318812 |
Recruitment Status :
Completed
First Posted : April 27, 2006
Results First Posted : May 2, 2014
Last Update Posted : May 10, 2016
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Condition or disease | Intervention/treatment | Phase |
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Anemia Renal Failure | Drug: Heme Iron Polypeptide (Proferrin) Drug: Iron sucrose (Venofer) | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Heme Iron
Heme Iron Polypeptide 11mg PO tid for 6 months
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Drug: Heme Iron Polypeptide (Proferrin)
Heme iron polypeptide 11mg po tid for 6 months
Other Name: Proferrin |
Active Comparator: Venofer
Venofer q month IV x 6 months
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Drug: Iron sucrose (Venofer)
Iron sucrose infusion IV q month x 6 months
Other Name: Venofer |
- Hemoglobin Concentration at 6 Months [ Time Frame: 6 months ]
- Ferritin [ Time Frame: 6 months ]Comparison of Ferritin at 6 months between the 2 Groups
- Transferrin Saturation [ Time Frame: 6 Months ]Comparison of Transferrin Saturation between the Groups

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318812
Canada, Ontario | |
The Ottawa Hospital Research Institute | |
Ottawa, Ontario, Canada, K1H 7W9 |
Principal Investigator: | Deborah Zimmerman, MD | Ottawa Hospital Research Institute |
Responsible Party: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00318812 |
Other Study ID Numbers: |
2005840-01H |
First Posted: | April 27, 2006 Key Record Dates |
Results First Posted: | May 2, 2014 |
Last Update Posted: | May 10, 2016 |
Last Verified: | April 2016 |
Randomized controlled trial (RCT) Prospective Studies ferric oxide, saccharated Peptides Heme Iron |
Erythropoietin, Recombinant Ferritin Transferrin Treatment Outcome |
Renal Insufficiency Anemia Anemia, Iron-Deficiency Hematologic Diseases Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Kidney Diseases |
Urologic Diseases Iron Ferric Oxide, Saccharated Trace Elements Micronutrients Physiological Effects of Drugs Hematinics |