Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

NCT03619850 · View on ClinicalTrials.gov ↗

Study Summary

Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.

Interventions

  • DRUG Ferumoxytol
  • DRUG Iron sucrose

Study Locations (20)

Other

  • Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika — Budapest
  • University Of Szeged — Szeged
  • Hospital of Lithuanian University of Health Sciences Kauno klinikos — Kaunas
  • Klaipeda Children's Hospital — Klaipėda
  • Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital) — Vilnius
  • Instituto Mexicano De Trasplantes S.C — Cuernavaca
  • JM Research, SC — Cuernavaca
  • Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara
  • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) — Mexico City
  • Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku — Bialystok
  • Specjalistyczne Gabinety Sp. z o.o — Krakow
  • University Children Hospital — Krakow

New York

  • The Feinstein Institute Medical Research Organization of Northwell Health, Inc. — Lake Success
  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) — New York
  • Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM) — The Bronx

Florida

  • Memorial Healthcare System — Hollywood

Michigan

  • Wayne State University — Detroit

Missouri

  • Children's Mercy Hospital — Kansas City

Ohio

  • Akron Nephrology Associates, Inc. — Akron

West Virginia

  • West Virginia University — Morgantown

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2018-08-13
Est. Completion 2024-08-31
Phase Phase 3

Sponsor

AMAG Pharmaceuticals

3 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03619850

The ClinicalTrials.gov registry entry for NCT03619850 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AMAG Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Kidney Disease; Iron Deficiency Anemia appearing as the primary indexed condition, and to 2 interventions — of which Ferumoxytol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03619850 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03619850 about?

NCT03619850 is a clinical study titled "A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)". Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) ...

What is the current status of trial NCT03619850?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2018-08-13. Estimated completion is 2024-08-31.

What conditions does trial NCT03619850 study?

This clinical trial studies the following conditions: Chronic Kidney Disease; Iron Deficiency Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03619850?

The interventions under investigation include: Ferumoxytol (DRUG), Iron sucrose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03619850?

This trial is sponsored by AMAG Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03619850 being conducted?

This trial has 20 study locations across Florida, Michigan, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial