Anemia, Chronic Kidney Disease
Conditions
Keywords
Iron, Anemia, CKD
Brief summary
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients
Detailed description
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
Interventions
DRUGVenofer (iron sucrose injection)
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 2 to 21 years of age * Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months * Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) \<60 * Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL * Ferritin ≤ 800 ng/mL * Transferrin saturation (TSAT) ≥ 20% to ≤ 50% * Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit
Exclusion criteria
* Known hypersensitivity to iron sucrose * Severe diseased of the liver, cardiovascular system, or hemopoietic system * Serious infection requiring hospitalization * Significant blood loss within the last 3 months * Bleeding disorders * Pregnancy / Lactation * Actively being treated for asthma * Hemoglobinopathy * Receiving a myelosuppressive drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event | baseline through week 12 | Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of Subjects Achieving Clinical Success | anytime during the 12 week post-baseline period | Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose) |
| Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | anytime during the 12-week post-baseline period | Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive |
| Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | anytime during the 12 week post-baseline period | Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive |
| Number of Subjects Achieving Clinical Success | anytime during the 12 week post-baseline period | Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose) |
| Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive | anytime during the 12 week post-baseline period | Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive |
| Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline | anytime during the 12 week post-baseline period | Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease \>25% in EPO dose from Baseline |
| Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline | anytime during the 12 week post-baseline period | Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease \>25% in EPO Dose from Baseline |
| Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive | anytime during the 12 week post-baseline period | Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive |
Countries
United States
Participant flow
Recruitment details
Hospitals and Medical Clinics; Study Period - October 24, 2005 through January 23, 2009
Pre-assignment details
Stable erythropoietin (EPO) dose (±25% of current dose) for 8 weeks prior to the qualifying screening visit.
Participants by arm
| Arm | Count |
|---|---|
| Venofer (0.5 mg/kg) 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | 49 |
| Venofer (1.0 mg/kg) 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | 47 |
| Venofer (2.0 mg/kg) 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | 49 |
| Total | 145 |
Baseline characteristics
| Characteristic | Venofer (0.5 mg/kg) | Venofer (1.0 mg/kg) | Venofer (2.0 mg/kg) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 44 Participants | 42 Participants | 44 Participants | 130 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Age, Continuous | 13.8 years STANDARD_DEVIATION 4.4 | 13.1 years STANDARD_DEVIATION 4.62 | 13.1 years STANDARD_DEVIATION 4.87 | 13.3 years STANDARD_DEVIATION 4.64 |
| Region of Enrollment Russian Federation | 23 participants | 16 participants | 24 participants | 63 participants |
| Region of Enrollment United States | 26 participants | 31 participants | 25 participants | 82 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 18 Participants | 61 Participants |
| Sex: Female, Male Male | 28 Participants | 25 Participants | 31 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 47 | 15 / 47 | 14 / 47 |
| serious Total, serious adverse events | 5 / 47 | 10 / 47 | 10 / 47 |
Outcome results
Primary
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm
Time frame: baseline through week 12
Population: Safety Population - Subjects who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event | 27 participants |
| Venofer (1.0 mg/kg) | Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event | 25 participants |
| Venofer (2.0 mg/kg) | Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event | 26 participants |
Secondary
Number of Subjects Achieving Clinical Success
Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Number of Subjects Achieving Clinical Success | 44 participants |
| Venofer (1.0 mg/kg) | Number of Subjects Achieving Clinical Success | 40 participants |
| Venofer (2.0 mg/kg) | Number of Subjects Achieving Clinical Success | 33 participants |
Secondary
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive
Time frame: anytime during the 12-week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | 46 participants |
| Venofer (1.0 mg/kg) | Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | 43 participants |
| Venofer (2.0 mg/kg) | Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | 38 participants |
Secondary
Percentage (%) of Subjects Achieving Clinical Success
Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Percentage (%) of Subjects Achieving Clinical Success | 95.7 percentage of subjects |
| Venofer (1.0 mg/kg) | Percentage (%) of Subjects Achieving Clinical Success | 88.9 percentage of subjects |
| Venofer (2.0 mg/kg) | Percentage (%) of Subjects Achieving Clinical Success | 82.5 percentage of subjects |
Secondary
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | 100.0 percentage of subjects |
| Venofer (1.0 mg/kg) | Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | 95.6 percentage of subjects |
| Venofer (2.0 mg/kg) | Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | 95.0 percentage of subjects |
Secondary
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease \>25% in EPO Dose from Baseline
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline | 100.0 percentage of subjects |
| Venofer (1.0 mg/kg) | Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline | 100.0 percentage of subjects |
| Venofer (2.0 mg/kg) | Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline | 97.5 percentage of subjects |
Secondary
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive | 95.7 percentage of subjects |
| Venofer (1.0 mg/kg) | Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive | 93.3 percentage of subjects |
| Venofer (2.0 mg/kg) | Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive | 92.5 percentage of subjects |
Secondary
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease \>25% in EPO dose from Baseline
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline | 46 participants |
| Venofer (1.0 mg/kg) | Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline | 45 participants |
| Venofer (2.0 mg/kg) | Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline | 39 participants |
Secondary
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive
Time frame: anytime during the 12 week post-baseline period
Population: mITT subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Venofer (0.5 mg/kg) | Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive | 44 participants |
| Venofer (1.0 mg/kg) | Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive | 42 participants |
| Venofer (2.0 mg/kg) | Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive | 37 participants |