CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Ferumoxytol intravenous +1 moredrug
Likely dose
Ferumoxytol intravenous 510 mgfrom 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.

Search/NCT02499354
NCT02499354Phase 2Completed
CompareCT.gov

Double-blind Comparator of Efficacy of Oral (Ferrous Sulfate) vs. Intravenous Iron (Ferumoxytol) for Treatment of the Restless Legs Syndrome (RLS) Occurring With Iron Deficient Anemia (IDA)

Auerbach Hematology Oncology Associates P C·interventional·Posted Jul 16, 2015·Updated Jan 30, 2024

In Brief

A Phase 2 clinical trial evaluating Ferumoxytol intravenous and Ferrous sulfate for Restless Legs Syndrome and Iron Deficiency Anemia. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The purpose of the study is to determine the relative effect size of standard IV and oral iron treatment of RLS with Iron deficiency anemia (IDA) and to determine the time course of treatment response.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Legs Syndrome, Iron Deficiency Anemia
CountriesUnited States
CollaboratorsAMAG Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 16, 2015
Enrollment StartAug 1, 2014
Primary CompletionSep 28, 2021
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 11.0 years ago

Interventions

Ferumoxytol intravenousdrug

IV iron, 2 vials of 510 mg given 2-7 days apart

Ferrous sulfatedrug

Oral iron, 325 mg tabs taken morning and evening