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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520780
Other study ID # FER-CARS-02
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2007
Est. completion date September 2009

Study information

Verified date March 2010
Source Vifor Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 456
Est. completion date September 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF) - Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III - Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations) - Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20% Exclusion Criteria: - History of acquired iron overload. - Known active infection, clinically significant bleeding, active malignancy. - Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) - Anaemia due to reasons other than iron deficiency - Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). - History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. - Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. - Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months. - Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.

Study Design


Intervention

Drug:
Ferinject ® (Ferric carboxymaltose)
Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit. After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).
Normal saline (0.9%)
During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.

Locations

Country Name City State
Argentina Research Sites Buenos Aires
Germany Research Site Bad Nauheim
Germany Research Site Berlin
Germany Research Site Göttingen
Germany Research Site Hannover
Germany Research Sites Heidelberg
Germany Research Site Herford
Germany Research Site Herne
Germany Research Site Kiel
Germany Research Site München
Greece Research Site Athens
Greece Research Site Heraklion
Italy Research Site Ascoli Piceno
Italy Research Site Pavia
Italy Research Site Rome
Italy Research Site Vicenza
Norway Research Site Stavanger
Poland Research Site Bialystok
Poland Research Site Krakow
Poland Research Site Opole
Poland Research Site Piotrkow Trybunalski
Poland Research Site Siedlce
Poland Research Site Torun
Poland Research Site Walbrzych
Poland Research Sites Warszawa
Poland Research Site Wloclawek
Poland Research Site Wroclaw
Poland Research Site Zabrze
Romania Research Site Brasov
Romania Research Sites Bucharest
Romania Reserach Site Craiova
Romania Research Sites Targu Mures
Russian Federation Reserach Sites Moscow
Russian Federation Research Sites Novgorod
Russian Federation Resarch Sites St. Petersburg
Spain Research Site Alicante
Spain Research Sites Barcelona
Spain Research Site Bilbao
Spain Research Site Madrid
Spain Research Site Valencia
Ukraine Research Site Dnipropetrovsk
Ukraine Research Site Donetsk
Ukraine Research Site Kharkiv
Ukraine Research Sites Kiev
Ukraine Research Site Lviv
Ukraine Research Site Mykolayiv
Ukraine Research Site Odessa
Ukraine Research Site Zaporozhye

Sponsors (3)

Lead Sponsor Collaborator
Vifor Pharma ClinStar, LLC, Syneos Health

Countries where clinical trial is conducted

Argentina,  Germany,  Greece,  Italy,  Norway,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy 24 weeks
Secondary Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability 24 weeks
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