At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Open-label, Single Arm Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous Ferric Carboxymaltose in Pediatric Subjects 1-17 Years Old With Iron Deficiency Anemia (IDA)
In Brief
A Phase 2 clinical trial evaluating Ferric Carboxymaltose (FCM) for Iron Deficiency Anemia (IDA). Completed, enrolled 35 participants across 10 sites in 2 countries.
Detailed Summary
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15 mg/kg dose of Ferric Carboxymaltose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia (IDA)
CountriesPoland, Russia
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedApr 2015
Primary CompletionJan 2017
Study CompletionJun 2017
TodayJul 2026
First PostedApr 7, 2015
Enrollment StartFeb 19, 2015
Primary CompletionJan 22, 2017
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.2 years ago
Interventions
Ferric Carboxymaltose (FCM)drug