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NCT03619850 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Chronic Kidney Disease; Iron Deficiency Anemia, sponsored by AMAG Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
- 20
- Study locations
NCT03619850 is a Phase 3 study of Chronic Kidney Disease; Iron Deficiency Anemia that is actively recruiting participants, run by AMAG Pharmaceuticals. The registered enrollment target is 129 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT03619850, a Phase 3 study of Chronic Kidney Disease; Iron Deficiency Anemia, is actively recruiting participants, sponsored by AMAG Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 3 |
Interested in This 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, categorized as Phase 3. 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 23 total studies on file at ClinicalTrials.gov.
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.
NCT03619850 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, New York, Florida.
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.
What interventions are being tested in trial NCT03619850?
The interventions under investigation include: Ferumoxytol (DRUG), Iron sucrose (DRUG).
Who is sponsoring clinical trial NCT03619850?
This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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.
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