NCT03619850 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)
| NCT ID | NCT03619850 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AMAG Pharmaceuticals, Inc. |
| Condition | Chronic Kidney Disease; Iron Deficiency Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 129 participants |
| Start Date | 2018-08-13 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 129 participants in total. It began in 2018-08-13 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female 2 years to \<18 years of age at time of consent 2. Has IDA defined as: a) hemoglobin \<12.0 g/dL and b) with either transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT\<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin \<12 g/dL 3. Has Chronic Kidney Disease defined as one of the following: 1. on chronic hemodialysis; 2. receiving chronic peritoneal dialysis; 3. estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2; 4. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for \> 3 months. 4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate 5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study Exclusion Criteria: 1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose 2. History of allergy to intravenous (IV) iron 3. History of multiple drug allergies (\>2) 4. Low systolic blood pressure (Age 1-9 years \<70 + \[age in years x 2\] mmHg, Age 10-17 years \<90 mmHg) 5. Hemoglobin ≤7.0 g/dL 6. Serum ferritin level \>600 ng/mL
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03619850 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Chronic Kidney Disease; Iron Deficiency Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03619850 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 129 participants.
Is NCT03619850 currently recruiting?
Yes, NCT03619850 is actively recruiting participants. Contact the research team at CTInterest@covispharma.com for enrollment information.
Where is the NCT03619850 trial being conducted?
This trial is being conducted at Hollywood, United States, Detroit, United States, Kansas City, United States, Lake Success, United States and 11 additional locations.
Who is sponsoring the NCT03619850 clinical trial?
NCT03619850 is sponsored by AMAG Pharmaceuticals, Inc.. The trial plans to enroll 129 participants.
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