Clinical Trials Register

Summary
EudraCT Number:	2011-001695-19
Sponsor's Protocol Code Number:	FER-CARS-05
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-03-02
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-001695-19

A.3

Full title of the trial

A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose with Placebo in Patients with Chronic Heart Failure and Iron Deficiency

Studio randomizzato, controllato in doppio cieco di Fase 4 per confrontare l’efficacia e la sicurezza di carbossimaltosio ferrico per via endovenosa e placebo in pazienti con scompenso cardiaco cronico e deficit di ferro

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to compare the use of ferric carboxymaltose with placebo in patients with chronic heart failure and iron deficiency

Uno studio per valutare l'uso di carbomaltosio ferrico nella performance di pazienti con deficit di ferro e scompenso cardiaco cronico

A.3.2

Name or abbreviated title of the trial where available

CONFIRM-HF

A.4.1

Sponsor's protocol code number

FER-CARS-05

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	VIFOR (INTERNATIONAL) INC.
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Vifor (International) Inc.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Vifor (International) Inc.
B.5.2	Functional name of contact point	Medical Information
B.5.3	Address:
B.5.3.1	Street Address	Flughofstrasse 61
B.5.3.2	Town/ city	Glattbrugg
B.5.3.3	Post code	CH-8152
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+41 58 851 8222
B.5.5	Fax number	+41 58 851 8002
B.5.6	E-mail	medinfo@viforpharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	FERINJECT*INF 1FL 10ML 50MG/ML
D.2.1.1.2	Name of the Marketing Authorisation holder	VIFOR FRANCE S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ferric carboxymaltose
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Iron deficency in patients with chronic heart failure

Carenza di ferro nei pazienti con insufficienza cardiaca cronica

E.1.1.1

Medical condition in easily understood language

Iron deficency in patients with chronic heart failure

Carenza di ferro nei pazienti con insufficienza cardiaca cronica

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10008908
E.1.2	Term	Chronic heart failure
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10022970
E.1.2	Term	Iron deficiency
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine, relative to placebo, the effect of iron repletion therapy using intarvenous (IV) FCM on exercise capacity assessed by 6-minute walk test (6MWT) at 24 weeks after initiation theraphy in subjects with CHF and ID

Per determinare, rispetto al placebo, l'effetto della terapia sostitutiva del ferro utilizzando FCM endovenosa sulla capacità di esercizio valutata con il 6-minute walk test (6MWT), 24 settimane dopo l'inizio della terapia in soggetti con CHF e ID

E.2.2

Secondary objectives of the trial

1. To evaluate the effect of IV FCM compared to placebo on New York
Heart Association (NYHA) functional class.
2. To evaluate the effect of IV FCM compared to placebo on relevant
biomarkers/laboratory parameters.
3. To evaluate the effect of IV FCM compared to placebo on
health related quality of life (QoL).
4. To evaluate the tolerability and safety of IV FCM compared to placebo.

1. Valutare gli effetti di FCM per via endovenosa in comparazione al placebo secondo la classe funzionale della New York Heart Association (NYHA).
2. Valutare gli effetti di FCM per via endovenosa in comparazione al placebo sui biomarcatori rilevanti / parametri di laboratorio.
3. Valutare gli effetti di FCM per via endovenosa in comparazione al placebo sulla qualità di vita correlata alla salute (QoL).
4. Valutare la tollerabilità e la sicurezza di FCM per via endovenosa in comparazione al placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA
II-III) on optimal background therapy for CHF
2. Reduced left ventricular ejection fraction
3. Capable of completing 6 minute walk test (6MWT)
4. At least 18 years of age and with written informed consent prior to
any study specific procedures

1. Soggetti con carenza di ferro e scompenso cardiaco cronico stabile (CHF) (NYHA II-III) sulla terapia di base ottimale per CHF
2. Ridotta frazione di eiezione ventricolare sinistra
3. In grado di completare il test 6 minuti (6MWT)
4. Almeno 18 anni di età e con il consenso informato scritto prima di effettuare eventuali procedure studio specifiche

E.4

Principal exclusion criteria

1. Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or
blood transfusion in previous 6 weeks prior to randomisation.
2. Exercise training program(s) in the 3 months prior to screening or
planned in the next 6 months
3.Chronic liver disease and/or elevated liver enzymes
4. Vitamin B12 and/or serum folate deficiency
5. Subject is not using adequate contraceptive precautions during the
study
6. Body weight ≤35 kg
6. No other significant cardiac or general disorders that would comprise
the ability to give informed consent and/or comply with study
procedures

1.Utilizzare (ESA), terapia di ferro per via endovenosa e / o trasfusione di sangue nelle precedenti 6 settimane prima della randomizzazione.
2. Esercizi di training nei 3 mesi precedenti lo screening o
previsto nei prossimi 6 mesi
3.malattia epatica cronica e / o aumento degli enzimi epatici
4. Vitamina B12 e / o carenza di folati sierici
5. Il soggetto non utilizza adeguate precauzioni contraccettive durante lo studio
6. Il peso corporeo ≤ 35 kg
6. Nessun altro disturbo cardiaco significativo o che comprenda la capacità di dare consenso informato e / o conformarsi con le procedure dello studio

E.5 End points

E.5.1

Primary end point(s)

Change in 6 minute walk test (6MWT) from baseline to Week 24 visit
after start of investigational drug

Variazione nel 6 minute walk test (6MWT) dalla visita al basale alla settimana 24 dopo l'inizio del farmaco in studio

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Settimana 24

E.5.2

Secondary end point(s)

1. Patient global assessment (PGA) score at Weeks 6, 12, 24, 36 and 52.
2. Change in NYHA class at Weeks 6, 12, 24, 36 and 52.
3. Change in 6MWT distance from baseline to Weeks 6, 12, 36 and 52.
4. Change in fatigue score from baseline to Weeks 6, 12, 24, 36 and 52.
5. Change in Kansas City cardiomyopathy questionnaire (KCCQ) from
baseline to Weeks 6, 12, 24, 36 and 52 (overall summary score and
symptom frequency score).
6. Change in European quality of life 5D (EQ-5D) questionnaire total
score from baseline to Weeks 6, 12, 24, 36 and 52.

1. Punteggio della valutazione globale del paziente (PGA) alle settimane 6,12,24,36 e 52.
2. Variazione nella classe NYHA alla settimana 6,12,24,36 e 52.
3. Variazione nella distanza del test 6MWT alla visita basale e alle settimane 6,12,36 e 52.
4.Variazione nel punteggio della fatica dalla visita al basale alle settimane 6,12,24,36 e 52.
5. Variazione nel questionario della cardiomiopatia Kansas City (KCCQ) dalla visita al basale alle settimane 6,12,24,36 e 52 (punteggio complessivo e punteggio dei sintomi di frequenza).
6. Variazione nel punteggio del questionario European quality of life 5D (EQ-5D) dalla visita al basale alle settimane 6,12,24,36 e 52.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 6, 12, 24, 36, and 52

Settimane 6, 12, 24, 36, e 52

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Russian Federation

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit of last subject

Ultima visita dell'ultimo paziente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

180

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

130

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Should patients require additional iron post repletion and completion of the study, either Ferinject or alternative iron replacement therapies are avaibale for use by treating physician

Se i pazienti richiedono ulteriori replezioni di ferro a completamento dello studio, sono disponibili ed ad uso del medico curante, sia Ferinject o terapie alternative per la sostituzione di ferro

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-02-13

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