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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heme Iron | Experimental | Heme Iron Polypeptide 11mg PO tid for 6 months |
|
| Venofer | Active Comparator | Venofer q month IV x 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heme Iron Polypeptide (Proferrin) | Drug | Heme iron polypeptide 11mg po tid for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentration at 6 Months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | Comparison of Ferritin at 6 months between the 2 Groups | 6 months |
| Transferrin Saturation | Comparison of Transferrin Saturation between the Groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Zimmerman, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 7W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23514036 | Derived | Nagaraju SP, Cohn A, Akbari A, Davis JL, Zimmerman DL. Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial. BMC Nephrol. 2013 Mar 20;14:64. doi: 10.1186/1471-2369-14-64. |
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15 of the 55 patients were screen failures due to; Hgb too high/low, ferritin level too high, Vitamin B level too low,one had bypass surgery
May 2007 - February 2011, 55 Chronic Kidney Disease patients >18years,with an estimated Glomerular Filtration Rate (eGFR) <30mls/minute and Hemoglobin (Hgb) of 90-110 were recruited. Recruitment was expanded to eGFR ≤60 and Hgb of 90-120g/L (females)and 90-135 g/L (males) with serum ferritin < 100 mcg /L or Transferrin Saturation (TSAT) < 20%)
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| ID | Title | Description |
|---|---|---|
| FG000 | Heme Iron | Heme Iron Polypeptide 11mg PO tid for 6 months |
| FG001 | Iron Sucrose | Iron Sucrose q month IV x 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heme Iron | Heme Iron Polypeptide 11mg PO tid for 6 months |
| BG001 | Iron Sucrose | Iron Sucrose q month IV x 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin Concentration at 6 Months | Posted | Median | Inter-Quartile Range | g/L | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heme Iron | Heme Iron Polypeptide 11mg PO tid for 6 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Hip iron | Non-systematic Assessment | Gastrointestinal complaints were the most common adverse effects in both groups with constipation and abdominal cramps being the most common in HIP group and constipation in IV sucrose group |
Recruitment for the trial was a challenge; over 1100 patients screened - 55 consented - 40 randomized
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Deborah Zimmerman, principal investigator | Ottawa Hospital Research Institute | 613-738-8400 | 82534 | dzimmerman@toh.on.ca |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Iron sucrose (Venofer) | Drug | Iron sucrose infusion IV q month x 6 months |
|
|
| 6 Months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Ferritin | Comparison of Ferritin at 6 months between the 2 Groups | Posted | Median | Inter-Quartile Range | ug/L | 6 months |
|
|
|
| Secondary | Transferrin Saturation | Comparison of Transferrin Saturation between the Groups | Posted | Median | Inter-Quartile Range | percentage of bound iron sites | 6 Months |
|
|
|
| 0 |
| 18 |
| 5 |
| 18 |
| EG001 | Iron Sucrose | Iron Sucrose q month IV x 6 months | 0 | 22 | 4 | 22 |
|
| abdominal cramps | Gastrointestinal disorders | Hip | Non-systematic Assessment |
|
| Symptomatic Hypotension | Cardiac disorders | IV surcrose | Non-systematic Assessment | symptomatic hypotesnion was seen in 3 patients in the IV sucrose arm and 0 patients in the HIP arm |
|
| Diarrhoea | Gastrointestinal disorders | Hip iron | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Hip iron | Non-systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Hip iron | Non-systematic Assessment |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders | Hip iron | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |