Not provided
Not provided
Not provided
Not provided
Not provided
Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-252 study as designed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).
Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.
Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest. Randomization was stratified by the following age cohorts: 12 to <18 years, 6 to <12 years, 2 to <6 years, and 6 months to <2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol | Experimental | Participants will receive 1 of the following 2 ferumoxytol dose regimens:
|
|
| Oral Iron | Active Comparator | Participants will receive oral iron: 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | Experimental: Ferumoxytol |
| |
| Oral Iron |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change In Hemoglobin From Baseline To Week 5 | Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the sponsor to discontinue the combined AMAG FER-CKD-252 and AMAG FER-CKD-251 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets. | Baseline, Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under The Curve Of Ferumoxytol | Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets. |
Not provided
Key Inclusion Criteria for this study include:
Key Exclusion Criteria for this study include:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMAG Pharmaceuticals, Inc. | Waltham | Massachusetts | 02451 | United States |
Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 (NCT01155375) and enrollment continued under Study AMAG-FER-CKD-251. Data is for the combined Study AMAG-FER-CKD-252 and Study AMAG-FER-CKD-251.The results for the combined studies are included in this record.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ferumoxytol | Participants received 1 of the following 2 ferumoxytol dose regimens:
|
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Active Comparator: Oral iron |
|
|
| Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose |
| FG001 | Oral Iron | Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35. |
|
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Population is defined as participants who received any amount of study drug. Data are for the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies. The safety analysis is based on actual treatment received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ferumoxytol | Participants received 1 of the following 2 ferumoxytol dose regimens:
|
| BG001 | Oral Iron | Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Mean Change In Hemoglobin From Baseline To Week 5 | Mean changes in hemoglobin from Baseline to Week 5 were to be presented. Despite efforts to complete the studies as designed, several factors contributed to significant challenges in enrollment and led the sponsor to discontinue the combined AMAG FER-CKD-252 and AMAG FER-CKD-251 studies. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this primary outcome measure cannot be summarized nor can the statistical analysis, as described in the protocol, be provided in a way that will provide any significant data based upon the limited study datasets. | Intent-to-Treat Population included all randomized participants who had received at least 1 dose of study drug. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible. | Posted | Baseline, Week 5 |
|
| ||||||||||||||||||||||
| Secondary | Pharmacokinetics: Area Under The Curve Of Ferumoxytol | Ferumoxytol concentrations were to be determined using a drug-specific nuclear magnetic resonance assay. Blood samples were to be collected at specified times predose and postdose at the time of the first dose from 6 participants in each age-dose group. Sampling for participants <6 years of age will be minimized to the fewest number of time points required for population PK analysis based on preliminary PK data from the first 2 age cohorts. Blood samples were collected, but not run through an analysis to obtain outcome measure data. As such, the data set for this secondary outcome measure cannot be summarized in a way that will provide any significant data based upon the limited study datasets. | The PK population included all randomized participants who received at least 1 dose of study drug and consented to PK sampling. Sample data were collected, but not run through any analysis to obtain outcome measure data. As such, summary of the data set is not possible. | Posted | Baseline; 10, 30, 120, and 360 minutes postdose; 24, 48, and 72 hours postdose |
|
Randomization up to 7 weeks (Follow-up)
Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The adverse events for the combined studies are included in this record.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferumoxytol | Participants received 1 of the following 2 ferumoxytol dose regimens:
| 0 | 8 | 1 | 8 | 6 | 8 |
| EG001 | Oral Iron | Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35. | 0 | 6 | 1 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ventricular flutter | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Residual urine volume decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
While sample data were collected, it was not run through any analysis to obtain the necessary outcome measure data. As such, summary of the data set is not possible.
If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data has been received by Sponsor, the Site and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 120 days to allow Sponsor to protect its interests.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | AMAG Pharmaceuticals, Inc. | CTInterest@covispharma.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| D007501 | Iron |
| C031621 | ferrous fumarate |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| OG001 | Oral Iron | Participants received oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35. |
|