NCT00994318

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

An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 626 (actual)
• Sponsor: Vifor Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks. 1. FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L. 2. FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L. 3. Daily oral iron with 200 mg iron/day (100 mg twice daily)

Conditions

• Iron Deficiency Anaemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	FCM (Ferric carboxymaltose) high ferritin target
DRUG	FCM (Ferric carboxymaltose) low ferritin target
DRUG	Oral Iron (Ferrous sulphate)

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-02-01
• Completion: 2014-02-01
• First posted: 2009-10-14
• Last updated: 2014-05-20
• Results posted: 2014-05-07

Locations

19 sites across 19 countries: United States, Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Turkey (Türkiye), United Kingdom