Last reviewed · How we verify
NCT01264679
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Phase 3 trial testing Ferumoxytol in Iron Deficiency Anemia in 8 participants. Terminated before completion.
24 April 2015
Quick facts
| Lead sponsor | AMAG Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 27 December 2011 |
| Primary completion | 24 April 2015 |
| Estimated completion | 24 April 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ferumoxytol (FERUMOXYTOL) — full drug profile →
Conditions studied
- Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →
Sponsor
AMAG Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 6 Months to 17, any sex, with Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Randomization up to 24 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (4 terms)
| Reaction | System | Ferumoxytol |
|---|---|---|
| Cardiac failure congestive | Cardiac disorders | — |
| Device breakage | General disorders | — |
| Ligament rupture | Injury, poisoning and procedural complications | — |
| Renal failure chronic | Renal and urinary disorders | — |
Other adverse events (28 terms — click to expand)
| Reaction | System | Ferumoxytol |
|---|---|---|
| Nasopharyngitis | Infections and infestations | — |
| Pharyngitis | Infections and infestations | — |
| Depression | Psychiatric disorders | — |
| Anuria | Renal and urinary disorders | — |
| Nephrogenic anaemia | Blood and lymphatic system disorders | — |
| Congestive cardiomyopathy | Cardiac disorders | — |
| Ventricular flutter | Cardiac disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Peritoneal lesion | Gastrointestinal disorders | — |
| Oedema peripheral | General disorders | — |
| Device related infection | Infections and infestations | — |
| Influenza | Infections and infestations | — |
| Oral herpes | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Procedural nausea | Injury, poisoning and procedural complications | — |
| Procedural vomiting | Injury, poisoning and procedural complications | — |
| Ureteric anastomosis complication | Injury, poisoning and procedural complications | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Joint swelling | Musculoskeletal and connective tissue disorders | — |
| Bladder spasm | Renal and urinary disorders | — |
| Renal colic | Renal and urinary disorders | — |
| Air embolism | Vascular disorders | — |
| Hypertension | Vascular disorders | — |
| Dental caries | Gastrointestinal disorders | — |
Most-reported serious reactions: Cardiac failure congestive, Device breakage, Ligament rupture, Renal failure chronic.
Data from ClinicalTrials.gov NCT01264679 adverse events section.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A Review of Clinical Translation of Inorganic Nanoparticles.
Anselmo AC, Mitragotri S. · · 2015 · cited 263× · PMID 25956384 · DOI 10.1208/s12248-015-9780-2 -
Engineering Iron Oxide Nanoparticles for Clinical Settings.
Cortajarena AL, Ortega D, Ocampo SM, Gonzalez-García A, et al · · 2014 · cited 78× · PMID 30023013 · DOI 10.5772/58841
Verify or expand the search:
- PubMed search for NCT01264679
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ferumoxytol
Trials testing the same drug.
- NCT07461948 — Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients · Phase 3 · recruiting
- NCT06483061 — Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy · Phase 2 · recruiting
- NCT05811377 — Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance · EARLY_PHASE1 · completed
- NCT04278651 — Early Antenatal Support for Iron Deficiency Anemia · Phase 4 · recruiting
- NCT03657433 — Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy · Phase 3 · completed
Other recruiting trials for Iron Deficiency Anemia
Currently open trials in the same condition.
- NCT07483645 — Effectiveness and Acceptability of LISEFEX® (Liposomal Iron With Vitamin C and Fiber) in People With Iron Deficiency Ane · active not recruiting
- NCT06012760 — The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion · NA · recruiting
- NCT06742528 — Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients · NA · recruiting
- NCT05929729 — Iron Deficiency Anemia (IDA) and the Brain · Phase 4 · recruiting
- NCT05985070 — Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults · NA · active not recruiting
Other AMAG Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT04593784 — Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults · Phase 2 · terminated
- NCT03973047 — Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alon · Phase 1 · completed
- NCT03619850 — A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatmen · Phase 3 · recruiting
- NCT03008616 — Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia · Phase 2, PHASE3 · terminated
- NCT02937766 — Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subc · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01264679 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AMAG Pharmaceuticals, Inc.
- Last refreshed: 28 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01264679.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing