MedTrace Logo

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

NCT02130063 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2018-09-27

Study results available
· View outcomes & findings →

Summary

The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

Conditions

  • Iron Deficiency Anaemia

Interventions

DRUG

iron isomaltoside 1000 (Monofer®)

DRUG

iron sucrose (Venofer®)

Sponsors & Collaborators

  • BioStata

    collaborator INDUSTRY

  • ClinStar, LLC

    collaborator INDUSTRY

  • Laboratory Corporation of America

    collaborator INDUSTRY

  • Pharmacosmos A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02130063 on ClinicalTrials.gov