Anemia
Conditions
Keywords
iron, peritoneal dialysis, anemia
Brief summary
This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
Detailed description
This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.
Interventions
DRUGVenofer and stable erythropoietin (EPO) regimen
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
DRUGstable erythropoietin (EPO) regimen
Stable erythropoietin (EPO) dose and no supplemental iron.
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 \>= 9.5 and \<= 11.5 g/dL. * Ferritin \<= 500 ng/ml. * Serum Transferrin Saturation (TSAT) \<= 25%. * Stable erythropoietin (EPO) Regimen for 8 weeks. * No iron for last 4 weeks before randomization.
Exclusion criteria
* Known Sensitivity to Iron Sucrose. * Suffering concomitant severe diseases of the liver & cardiovascular system. * Pregnancy / Lactation. * Inadequate dialysis. * Current treatment for asthma. * Significant blood loss. * Probability of need for transfusion or transfusion within 1 week of enrollment. * Anticipated major surgery. * Hemochromatosis / hemosiderosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change From Baseline to the Highest Hemoglobin up to Day 71 | Change from Baseline up to Day 71 |
Secondary
| Measure | Time frame |
|---|---|
| The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 | Change from Baseline up to Day 71 |
| The Mean Change From Baseline to the Highest Ferritin up to Day 71 | Change from Baseline up to Day 71 |
| The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 | Change from Baseline up to Day 71 |
Participant flow
Recruitment details
Recruitment Period: July 29, 2002 - September 6, 2004 Locations: Hospitals and Medical Clinics
Participants by arm
| Arm | Count |
|---|---|
| Group A: Venofer and Erythropoietin EPO Fixed Dose Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. | 75 |
| Group B: Erythropoietin EPO Fixed Dose Only Stable erythropoietin (EPO) dose and no supplemental iron. | 46 |
| Total | 121 |
Baseline characteristics
| Characteristic | Group A: Venofer and Erythropoietin EPO Fixed Dose | Group B: Erythropoietin EPO Fixed Dose Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 36 Participants | 97 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Female | 46 Participants | 25 Participants | 71 Participants |
| Sex: Female, Male Male | 29 Participants | 21 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 75 | 20 / 46 |
| serious Total, serious adverse events | 9 / 75 | 5 / 46 |
Outcome results
Primary
Mean Change From Baseline to the Highest Hemoglobin up to Day 71
Time frame: Change from Baseline up to Day 71
Population: Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Venofer and Erythropoietin EPO Fixed Dose | Mean Change From Baseline to the Highest Hemoglobin up to Day 71 | 1.3 g/dL | Standard Deviation 1.1 |
| Group B: Erythropoietin EPO Fixed Dose Only | Mean Change From Baseline to the Highest Hemoglobin up to Day 71 | .7 g/dL | Standard Deviation 1.1 |
Secondary
The Mean Change From Baseline to the Highest Ferritin up to Day 71
Time frame: Change from Baseline up to Day 71
Population: Intent-to-Treat Population (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Venofer and Erythropoietin EPO Fixed Dose | The Mean Change From Baseline to the Highest Ferritin up to Day 71 | 545.05 ng/mL | Standard Deviation 585.8 |
| Group B: Erythropoietin EPO Fixed Dose Only | The Mean Change From Baseline to the Highest Ferritin up to Day 71 | 70.523 ng/mL | Standard Deviation 159.7 |
Secondary
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
Time frame: Change from Baseline up to Day 71
Population: Intent-to-Treat Population (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Venofer and Erythropoietin EPO Fixed Dose | The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 | 0.7226 percentage of change | Standard Deviation 1.36 |
| Group B: Erythropoietin EPO Fixed Dose Only | The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 | 0.4630 percentage of change | Standard Deviation 1.01 |
Secondary
The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
Time frame: Change from Baseline up to Day 71
Population: Intent-to-Treat Population (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Venofer and Erythropoietin EPO Fixed Dose | The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 | 18.176 percentage of change | Standard Deviation 15.53 |
| Group B: Erythropoietin EPO Fixed Dose Only | The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 | 10.383 percentage of change | Standard Deviation 12.27 |