MedTrace Logo

Pilot Study: Randomized, Placebo-controlled Comparator Trial of IV vs Oral Iron Treatment of RLS With IDA. (IVOR-IDA)

NCT02499354 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-01-30

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Ferumoxytol intravenous

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

DRUG

Ferrous sulfate

Oral iron, 325 mg tabs taken morning and evening

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Auerbach Hematology Oncology Associates P C

    lead OTHER

Principal Investigators

  • Michael Auerbach, MD · Auerbach Hematology and Oncology Associates, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2021-09-28
Completion
2022-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02499354 on ClinicalTrials.gov