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NCT01155388
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
Phase 3 trial testing Ferumoxytol in Iron Deficiency Anemia in 14 participants. Terminated before completion.
24 June 2014
Quick facts
| Lead sponsor | AMAG Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 17 October 2011 |
| Primary completion | 24 June 2014 |
| Estimated completion | 24 June 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ferumoxytol (FERUMOXYTOL) — full drug profile →
- Oral Iron
Conditions studied
- Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →
- Nondialysis-dependent Chronic Kidney Disease — all drugs for Nondialysis-dependent Chronic Kidney Disease →
Sponsor
AMAG Pharmaceuticals, Inc. — full company profile →
Who can join
Adults 6 Months to 17, any sex, with Iron Deficiency Anemia or Nondialysis-dependent Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Randomization up to 7 weeks (Follow-up). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (2 terms)
| Reaction | System | Ferumoxytol | Oral Iron |
|---|---|---|---|
| Acute gastroenteritis | Infections and infestations | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
Other adverse events (23 terms — click to expand)
| Reaction | System | Ferumoxytol | Oral Iron |
|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Ventricular flutter | Cardiac disorders | — | — |
| Food poisoning | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Hypersensitivity | Immune system disorders | — | — |
| Chronic sinusitis | Infections and infestations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Pharyngitis | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Viral pharyngitis | Infections and infestations | — | — |
| Procedural hypotension | Injury, poisoning and procedural complications | — | — |
| Procedural nausea | Injury, poisoning and procedural complications | — | — |
| Skin injury | Injury, poisoning and procedural complications | — | — |
| Residual urine volume decreased | Investigations | — | — |
| Fluid retention | Metabolism and nutrition disorders | — | — |
| Hypermagnesaemia | Metabolism and nutrition disorders | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Sleep disorder | Psychiatric disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypertension | Vascular disorders | — | — |
Most-reported serious reactions: Acute gastroenteritis, Hyperkalemia.
Data from ClinicalTrials.gov NCT01155388 adverse events section.
Sponsor's own description
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Clinical Trials of Thermosensitive Nanomaterials: An Overview.
Nardecchia S, Sánchez-Moreno P, Sánchez-Moreno P, Vicente J, et al · · 2019 · cited 60× · PMID 30717386 · DOI 10.3390/nano9020191 -
Parenteral versus oral iron therapy for adults and children with chronic kidney disease.
O'Lone EL, Hodson EM, Nistor I, Bolignano D, et al · · 2019 · cited 28× · PMID 30790278 · DOI 10.1002/14651858.cd007857.pub3
Verify or expand the search:
- PubMed search for NCT01155388
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT04278651 — Early Antenatal Support for Iron Deficiency Anemia · Phase 4 · recruiting
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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 NCT01155388 (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/NCT01155388.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing