Study overview

This prospective, open-label, multicenter Phase 3 study evaluates intravenous ferric derisomaltose in children from birth to under 18 years of age who have iron-deficiency anemia associated with non-dialysis-dependent chronic kidney disease or who cannot tolerate or have not responded adequately to oral iron. The protocol includes clinical-pharmacology assessments in a subset of participants and assigns dosing according to protocol-defined age, weight, and cohort rules.

What researchers are evaluating

Researchers are examining how ferric derisomaltose is processed in the body, its effect on iron and hemoglobin measures, and its safety and tolerability. Procedures may include examinations, medical and medication reviews, blood collection, vital signs, monitoring during and after infusion, and follow-up for adverse events. Because the study is open label, participants and investigators know which study treatment is administered. Intravenous iron can cause important reactions, and trained clinical staff follow protocol precautions and emergency procedures.

Considering participation

Potential eligibility may depend on age, weight, laboratory confirmation of iron-deficiency anemia, kidney function, response or intolerance to oral iron, prior iron therapy, allergies, infections, other medical conditions, and protocol timing. A parent or legal guardian generally provides permission, and children able to understand the research may also provide assent. The current protocol and qualified investigators control all eligibility decisions. Study status and local availability can change, and screening does not guarantee enrollment. Participation is voluntary. The research team explains infusion procedures, blood draws, foreseeable risks, possible benefits, alternatives, privacy protections, and the right to withdraw. Do not send a child’s medical records, laboratory results, insurance information, or other sensitive data in an initial inquiry.

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