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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: Recruiting Phase 3 study of Chronic Kidney Disease; Iron Deficiency Anemia, sponsored by AMAG Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
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 |
What NCT03619850 shows while recruiting
NCT03619850 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03619850's enrollment target sits among peer trials
129 1598th of 2000 higher than 400 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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