Anemia, Renal Failure
Conditions
Keywords
Randomized controlled trial (RCT), Prospective Studies, ferric oxide, saccharated, Peptides, Heme, Iron, Erythropoietin,, Recombinant, Ferritin, Transferrin, Treatment Outcome
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.
Interventions
DRUGHeme Iron Polypeptide (Proferrin)
Heme iron polypeptide 11mg po tid for 6 months
Iron sucrose infusion IV q month x 6 months
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin Concentration at 6 Months | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ferritin | 6 months | Comparison of Ferritin at 6 months between the 2 Groups |
| Transferrin Saturation | 6 Months | Comparison of Transferrin Saturation between the Groups |
Countries
Canada
Participant flow
Recruitment details
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%)
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Heme Iron Heme Iron Polypeptide 11mg PO tid for 6 months | 18 |
| Iron Sucrose Iron Sucrose q month IV x 6 months | 22 |
| Total | 40 |
Baseline characteristics
| Characteristic | Heme Iron | Iron Sucrose | Total |
|---|---|---|---|
| Age, Continuous | 76 years | 66 years | 68 years |
| Region of Enrollment Canada | 18 participants | 22 participants | 40 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 18 | 4 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
Primary
Hemoglobin Concentration at 6 Months
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heme Iron | Hemoglobin Concentration at 6 Months | 117 g/L |
| Iron Sucrose | Hemoglobin Concentration at 6 Months | 113 g/L |
Secondary
Ferritin
Comparison of Ferritin at 6 months between the 2 Groups
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heme Iron | Ferritin | 85.5 ug/L |
| Iron Sucrose | Ferritin | 244 ug/L |
Secondary
Transferrin Saturation
Comparison of Transferrin Saturation between the Groups
Time frame: 6 Months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Heme Iron | Transferrin Saturation | 21.5 percentage of bound iron sites |
| Iron Sucrose | Transferrin Saturation | 21.5 percentage of bound iron sites |