Anemia
Conditions
Keywords
CKD, iron, anemia
Brief summary
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
Detailed description
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.
Interventions
DRUGVenofer
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
DRUGFerrous Sulfate
oral iron tablets; 325 mg three times a day orally for 56 days
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hemoglobin \< or = 11.5 gm/dL * Stable dose or not receiving EPO * Renal Anemia
Exclusion criteria
* IV iron with last 6 months * Chronic infection, malignancy,major surgery within last month * Blood Transfusion with last two months * Significant blood loss within last 3 months * Concomitant sever diseases of the liver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients With an Increase in Hemoglobin >= 1gm/dL. | Change from Baseline up to Day 56 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Ferritin (ng/mL) From Baseline to Day 56 | Change from Baseline at Day 56 | — |
| Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 | Change from Baseline at Day 56 | — |
| Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 | Change from Baseline up to Day 56 | — |
| Number of Subjects With a Clinical Response | Change from Baseline up to Day 56 | Clinical Response (change in Hemoblobin (Hgb) \>= 1gm/dL and change in ferritin \>= 160ng/ml) |
| Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 | Change from Baseline up to Day 56 | — |
| Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 | Change from Baseline at Day 56 | — |
Countries
United States
Participant flow
Recruitment details
Recruitment period: August 2003 to October 2004. Locations: Hospitals, Medical Clinics
Pre-assignment details
Eligibility requirements: Serum Transferrin Saturation (TSAT) \<= to 25%, Ferritin \<= to 300 ng/mL, and no iron following enrollment. At randomization subjects were stratified by gender, hemoglobin (Hgb) levels (\< or = to 9.0 g/dL, 9.1 - 10.0 g/dL, 10.1 - 11.0 g/dL), and erythropoietin use.
Participants by arm
| Arm | Count |
|---|---|
| Venofer iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. | 91 |
| Ferrous Sulfate oral iron tablets; 325 mg three times a day orally for 56 days | 91 |
| Total | 182 |
Baseline characteristics
| Characteristic | Venofer | Ferrous Sulfate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 42 Participants | 48 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 43 Participants | 92 Participants |
| Sex: Female, Male Female | 62 Participants | 64 Participants | 126 Participants |
| Sex: Female, Male Male | 29 Participants | 27 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 91 | 42 / 91 |
| serious Total, serious adverse events | 10 / 91 | 6 / 91 |
Outcome results
Primary
Patients With an Increase in Hemoglobin >= 1gm/dL.
Time frame: Change from Baseline up to Day 56
Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer | Patients With an Increase in Hemoglobin >= 1gm/dL. | 35 participants |
| Ferrous Sulfate | Patients With an Increase in Hemoglobin >= 1gm/dL. | 23 participants |
Secondary
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
Time frame: Change from Baseline up to Day 56
Population: Only subjects who completed the study from the Intent to Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venofer | Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 | 391.7 ng/mL | Standard Deviation 213.19 |
| Ferrous Sulfate | Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 | 45 ng/mL | Standard Deviation 52.19 |
Secondary
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
Time frame: Change from Baseline up to Day 56
Population: Only subjects who completed the study from the Intent to Treat (ITT) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venofer | Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 | 1.1 g/dL | Standard Deviation 0.94 |
| Ferrous Sulfate | Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 | .8 g/dL | Standard Deviation 0.78 |
Secondary
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
Time frame: Change from Baseline at Day 56
Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venofer | Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 | .7 g/dL | Standard Deviation 0.94 |
| Ferrous Sulfate | Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 | .3 g/dL | Standard Deviation 0.9 |
Secondary
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
Time frame: Change from Baseline at Day 56
Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venofer | Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 | 8.5 percentage of change | Standard Deviation 8.31 |
| Ferrous Sulfate | Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 | 5.5 percentage of change | Standard Deviation 9.14 |
Secondary
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
Time frame: Change from Baseline at Day 56
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venofer | Mean Change in Ferritin (ng/mL) From Baseline to Day 56 | 230 ng/mL | Standard Deviation 138.2 |
| Ferrous Sulfate | Mean Change in Ferritin (ng/mL) From Baseline to Day 56 | 30 ng/mL | Standard Deviation 54.63 |
Secondary
Number of Subjects With a Clinical Response
Clinical Response (change in Hemoblobin (Hgb) \>= 1gm/dL and change in ferritin \>= 160ng/ml)
Time frame: Change from Baseline up to Day 56
Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer | Number of Subjects With a Clinical Response | 31 participants |
| Ferrous Sulfate | Number of Subjects With a Clinical Response | 1 participants |