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Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

NCT00994318 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2014-05-20

Study results available
· View outcomes & findings →

Summary

Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).

Conditions

Interventions

DRUG

FCM (Ferric carboxymaltose) high ferritin target

DRUG

FCM (Ferric carboxymaltose) low ferritin target

DRUG

Oral Iron (Ferrous sulphate)

Sponsors & Collaborators

  • American Regent, Inc.

    collaborator INDUSTRY

  • ICON Clinical Research

    collaborator INDUSTRY

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Iain Macdougall · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2013-02-28
Completion
2014-02-28

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

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 NCT00994318 on ClinicalTrials.gov