Trial intelligence / Profile preview

Neurovascular and Neurocognitive Consequences of Iron Deficiency Anemia

NCT05929729Phase 4

Key facts

Status: Recruiting
Start: Dec 2023
Primary completion: Sep 2028
Countries: 1
Sponsor: Children's Hospital Los Angeles
Modality: Inorganic Nanoparticles, Small Molecules

Drugs: ferric derisomaltose
Conditions: iron deficiency anemia (IDA)

Overview

Phase 4, randomised, open-label trial of ferric derisomaltose in iron deficiency anemia (IDA) (3 arms), sponsored by Children's Hospital Los Angeles. Primary endpoints: Regional cerebrovascular oxygen delivery at Day 365, Cerebrovascular flow reactivity at Day 365 and 14 more. Started Dec 2023; status: recruiting.

Design

3 arms

Study design: RandomizedOpen-label

Intravenous (IV) iron
Single dose of IV Ferric Derisomaltose (20 mg/kg) followed by oral NovaFerrum maintenance after 3 months.
Standard of care iron
Oral iron therapy prescribed by primary care provider.
Healthy Controls
Observational only.

Who it enrols

Adult women aged 16-60 with moderate to severe iron deficiency anemia or healthy controls. Excludes those with morbid obesity, pregnancy, HIV, or systemic inflammatory diseases.

Endpoints

Primary

Regional cerebrovascular oxygen deliveryDay 365
Cerebrovascular flow reactivityDay 365
Blood brain barrier permeability surface area productDay 365
Cerebral metabolic rate of oxygenDay 365
Total brain blood flowDay 365

Secondary

Patient reported outcomes of health and quality of lifeDay 365
Patient reported outcomes of fatigueDay 365
MRI measured brain ironDay 365
HemoglobinDay 365
FerritinDay 365
Restless Legs Syndrome (RLS)Day 365

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