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Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-253 study as designed.
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Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.
Study AMAG-FER-CKD-251 was a study evaluating the efficacy and safety of intravenous (IV) ferumoxytol in pediatric participants with dialysis-dependent 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 chronic kidney disease.
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.
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.
Participants who completed the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies had the option of participating in this extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol | Experimental | When a participant has persistent or recurrent IDA (defined as hemoglobin <12.0 grams [g]/deciliter [dL] and with either transferrin saturation <40% or ferritin <100 nanograms/milliliter), the participant will begin a 7-week treatment period. Participants will receive 2 IV injections of ferumoxytol 7.0 milligrams (mg) iron/kilogram (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | IV Ferumoxytol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change In Hemoglobin From Baseline To Week 5 | Mean changes in hemoglobin following the first course of ferumoxytol 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-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. 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 |
|---|---|---|
| Proportion Of Participants With An Increase In Hemoglobin From Baseline To Week 5 And To Week 7 | The proportion of participants with an increase hemoglobin to ≥1.0 g/dL or to ≥12.0 g/dL during the period from Baseline to Week 5 and to Week 7 following each course of ferumoxytol was to be presented. However, 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-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. 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. |
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Key Inclusion Criteria include:
Key Exclusion Criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMAG Pharmaceuticals, Inc. | Waltham | Massachusetts | 02451 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferumoxytol | When a participant had persistent or recurrent iron deficiency anemia (IDA) (defined as hemoglobin <12.0 grams [g]/deciliter [dL] and with either transferrin saturation [TSAT] <40% or ferritin <100 nanograms [ng]/milliliter [mL]), the participant began a 7-week treatment period. Participants received 2 intravenous (IV) injections of ferumoxytol 7.0 milligrams [mg] iron (Fe)/kilogram (kg) (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Population included all randomized participants who had received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferumoxytol | When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period. |
| 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 |
| 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 following the first course of ferumoxytol 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-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. 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. | ITT 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 |
|
Randomization up to 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferumoxytol | When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrogenic anaemia | Blood and lymphatic system 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | AMAG Pharmaceuticals, Inc. | CTInterest@covispharma.com |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| Baseline, Week 5 and Week 7 |
| Mean Change In TSAT From Baseline To Week 5 And To Week 7 | Mean changes in TSAT following the first course of ferumoxytol from Baseline to Week 5 and to Week 7 were to be presented. However, 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-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. 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. | Baseline, Week 5 and Week 7 |
| Withdrawal by Subject |
|
| Participants |
|
| Age, Continuous | The birth date is missing for 1 of the 7 pediatric participants. Therefore, mean and standard deviation for Age, Continuous is based on 6 participants. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ferumoxytol |
When a participant had persistent or recurrent IDA (defined as hemoglobin <12.0 g/dL and with either TSAT ≤40% or ferritin <100 ng/mL), the participant began a 7-week treatment period. Participants received 2 IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first dose administered on Day 1 and the second on Days 3 through 9 of the Treatment Period. |
|
| Secondary | Proportion Of Participants With An Increase In Hemoglobin From Baseline To Week 5 And To Week 7 | The proportion of participants with an increase hemoglobin to ≥1.0 g/dL or to ≥12.0 g/dL during the period from Baseline to Week 5 and to Week 7 following each course of ferumoxytol was to be presented. However, 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-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. 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. | ITT 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 and Week 7 |
|
|
| Secondary | Mean Change In TSAT From Baseline To Week 5 And To Week 7 | Mean changes in TSAT following the first course of ferumoxytol from Baseline to Week 5 and to Week 7 were to be presented. However, 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-251 and AMAG-FER-CKD-252 studies, and the AMAG-FER-CKD-253 study. 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. | ITT 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 and Week 7 |
|
|
| 0 |
| 7 |
| 3 |
| 7 |
| 7 |
| 7 |
| Device breakage | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ventricular flutter | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peritoneal lesion | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Ureteric anastomosis complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Anuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
|
| Air embolism | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
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.
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008903 |
| Minerals |