Evaluating ferumoxytol for treating iron deficiency anemia in children with chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial aims to assess the safety and efficacy of ferumoxytol compared to iron sucrose in pediatric patients suffering from iron deficiency anemia (IDA) associated with chronic kidney disease (CKD). The study will involve approximately 125 participants who will be randomized to receive either ferumoxytol or iron sucrose over a treatment period of 5 weeks, following a 2-week screening phase. The trial will also evaluate the pharmacokinetics and pharmacodynamics of ferumoxytol in this population. Participants will receive two intravenous infusions of ferumoxytol or a series of iron sucrose doses based on their dialysis status.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Mercy Hospital
  Kansas City, Missouri, United States Recruiting
• Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
  The Bronx, New York, United States Recruiting
• Akron Nephrology Associates, Inc.
  Akron, Ohio, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting
• Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
  Budapest, Hungary Recruiting
• University Of Szeged
  Szeged, Hungary Recruiting

Study contacts

• Study coordinator: Clinical Trial Interest
• Email: CTInterest@covispharma.com
• Phone: 1-877-374 -4177

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observational look at how Kremezin works in adults with advanced chronic kidney disease

  This study tests whether Kremezin helps adults with advanced kidney disease when used as part of routine care, by tracking safety and kidney function over up to 48 weeks.

  Recruiting HK inno.N Corporation · Seoul · NCT07930169

• Iron treatment for children and young adults with Crohn’s disease and iron deficiency anemia

  This study tests how different iron treatment approaches work for kids and young adults with Crohn’s disease and iron deficiency anemia.

  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT07925450

• Kidney and Heart Health in Adults with Type 2 Diabetes and CKD Treated with Semaglutide in China

  This study tests whether semaglutide injections help kidney and heart health in adults with type 2 diabetes and chronic kidney disease.

  Recruiting Phase 4 Novo Nordisk A/S · Fuyang, Anhui and 25 other locations · NCT07900438

• High BMI and periodontitis in Thai adults under 60

  This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.

  Recruiting Mahidol University · Bangkok, Ratchathewi · NCT07880717

• Optimised Cardio-Renal Care for CKD and heart disease

  This study tests whether a specialised Cardio-Renal Clinic can improve heart and kidney health and quality of life for adults with chronic kidney disease and cardiovascular disease.

  Recruiting Odense University Hospital · Svendborg · NCT07835828

• NMR-based Risk Test and Digital Health Support for midlife adults in Eloisa

  This study tests whether an NMR metabolomics risk test can guide tailored digital health programs for midlife adults at risk of diabetes, heart disease, stroke, kidney disease, or fatty liver.

  Recruiting University of Eastern Finland · Savonlinna · NCT07820800

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.