A Phase 3 interventional study of Ferumoxytol in Iron Deficiency Anemia, sponsored by AMAG Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by AMAG Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 8 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →AMAG Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria include:
Key Exclusion Criteria include:
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.
Drug: Ferumoxytol
IV Ferumoxytol
Also known as: Feraheme
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.
Time frame: Baseline, Week 5
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.
Time frame: 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.
Time frame: Baseline, Week 5 and Week 7
| Milestone | Ferumoxytol |
|---|---|
| Started | 8 |
| Received at least 1 dose of study drug | 7 |
| Completed | 3 |
| Not completed | 5 |
| Withdrew: Participation in another clinical trial | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Sponsor's suspension of dosing | 2 |
| Withdrew: Withdrawal by subject | 1 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Randomization up to 24 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ferumoxytol | 0/7 (0%) | 3/7 (42.9%) | 7/7 (100%) |
| Event | Ferumoxytol |
|---|---|
| Cardiac failure congestiveCardiac disorders | 1/7 |
| Device breakageGeneral disorders | 1/7 |
| Ligament ruptureInjury, poisoning and procedural complications | 1/7 |
| Renal failure chronicRenal and urinary disorders | 1/7 |
| Event | Ferumoxytol |
|---|---|
| NasopharyngitisInfections and infestations | 2/7 |
| PharyngitisInfections and infestations | 2/7 |
| DepressionPsychiatric disorders | 2/7 |
| AnuriaRenal and urinary disorders | 2/7 |
| Nephrogenic anaemiaBlood and lymphatic system disorders | 1/7 |
| Congestive cardiomyopathyCardiac disorders | 1/7 |
| Ventricular flutterCardiac disorders | 1/7 |
| VertigoEar and labyrinth disorders | 1/7 |
| DiarrhoeaGastrointestinal disorders | 1/7 |
| GastritisGastrointestinal disorders | 1/7 |
The Safety Population included all randomized participants who had received at least 1 dose of study drug.
| Age, Categorical(Participants) | Ferumoxytol |
|---|---|
| <=18 years | 7 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Ferumoxytol |
|---|---|
| Mean | 15.3 ± 1.51 |
| Sex: Female, Male(Participants) | Ferumoxytol |
|---|---|
| Female | 4 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Ferumoxytol |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 4 |
| Unknown or Not Reported | 0 |
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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AMAG Pharmaceuticals, Inc.