Clinical Trials Register

Summary
EudraCT Number:	2012-001134-33
Sponsor's Protocol Code Number:	iCHF
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-08-28
Trial 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

Germany - BfArM

A.2

EudraCT number

2012-001134-33

A.3

Full title of the trial

Randomized, Double-Blind, Placebo-Controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients with Congestive Heart Failure

Eine randomisierte, doppelblinde, Placebo-kontrollierte Studie mit Eisen-Carboxy-maltose in Patienten mit Herzinsuffizienz

A.3.1

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

Ferric Carboxymaltose Versus Placebo in Patients with Congestive Heart Failure

Eisen-Carboxy-maltose in Patienten mit Herzinsuffizienz

A.3.2

Name or abbreviated title of the trial where available

Iron in Congestive Heart Failure – iCHF

A.4.1

Sponsor's protocol code number

iCHF

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	Universitätsklinikum Ulm
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Vifor Pharma
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitäres Herzzentrum Hamburg
B.5.2	Functional name of contact point	Mahir Karakas
B.5.3	Address:
B.5.3.1	Street Address	Martinistr. 52
B.5.3.2	Town/ city	Hamburg
B.5.3.3	Post code	D-20246
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4940741057614
B.5.5	Fax number	+4940741052765
B.5.6	E-mail	Mahir.Karakas1@gmail.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 50 mg Eisen/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Vifor France SA
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Solution for injection/infusion
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	0009007-72-1
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/infusion
D.8.4	Route of administration of the placebo	Intravenous bolus use (Noncurrent)

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Congestive heart failure (CHF)

Kongestive Herzinsuffizienz (CHF)

E.1.1.1

Medical condition in easily understood language

Congestive heart failure (CHF)

Herzschwäche

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	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10019284
E.1.2	Term	Heart failure, congestive
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve LV-EF in patients with CHF and iron deficiency as determined by cardiac MRI.

Primäres Ziel ist die Untersuchung des Einflusses von Eisen-Carboxymaltose bei Patienten mit chronischer Herzinsuffizienz und Eisenmangel auf die myokardiale Pumpfunktion (linksventrikuläre Ejektionsfraktion = LV-EF, gemessen durch kardiologisches MRT)

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Congestive heart failure
-at least 18 years of age
-iron deficiency
-NYHA class II or III
-LVEF < 40%

-Patienten mit chronischer Herzinsuffizienz
-mindestens 18 Jahre
-Eisenmangel (Ferritin < 100 ng/ml oder Ferritin < 300ng/ml und Transferrin Sättigung < 20%)
-NYHA functional class II-III)
-LVEF ≤ 40% im EKG oder kardiologischem MRI

E.4

Principal exclusion criteria

-Known sensitivity to any of the products to be administered during dosing
-immediate need of transfusion
-patients presenting with an active infection
-Thalassaemia
-other forms of microcytic anemia not caused by iron deficiency
- history of acquired iron overload
-need for revascularization
-STEMI or Non-STEMI during the past 4 months
-women who are pregnant or of childbearing age and not using medically acceptable effective contraception.

-Patienten mit einer bekannten Allergie gegen Inhaltsstoffe der Prüfmedikation oder ähnlichen Substanzen
-Sofortige Bluttransfusion ist notwendig
-Aktive Infektion ( z. Bsp. Körpertemperatur > 38,5°C)
-Thalassaemia
-In medizinischer Vorgeschichte gab es eine erworbene Eisenüberladung
-Akuter Myokardinfarkt oder akutes Koronarsyndrom transitorische ischämische Attacke oder Schlaganfall innerhalb der letzten 3 Monate vor Einschluss
-Koronararterien-Bypass OP
-Schwangerschaft und Stillen
-unzureichende Verhütung bis zu 1 Monat nach Verabreichung der letzten Dosis der Prüfmedikation

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to week 12 in left-ventricular ejection fraction (LV-EF) as determined by cardiac-MRI. If MRI is not feasible due to cardiac metal implants (like pace-maker or heart defibrillator) another appropriate routine method may be used, like cardiac computed tomography (CT) (expected in a maximum of 5 from 100 subjects).

Änderung des LV-EF Wertes nach Bestimmung im kardiologischen MRT (Vergleich LV-EF-Wert vor Behandlung mit Prüfpräparat mit LV-EF-Wert 12 Wochen nach Behandlung mit Prüfpräparat). Wenn MRT aufgrund von metallischen Implantaten (Herzschrittmacher, Defibrillator) nicht möglich ist, kann auch ein anderes geeignetes Routineverfahren verwendet werden, wie Herz-Computertomographie (CT)

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3: Week 12 ( day 84 ± 14 days)

Visite 3: Woche 12 (Tag 84 ± 14 Tage)

E.5.2

Secondary end point(s)

Change from baseline to week 12 in:
- semi-quantitative perfusion measurement by cardiac-MRI
- ventricular and atrial diameters and wall thickness as quantified by cardiac-MRI
- glomerular filtration rate as determined by radionuclide measurement
- NYHA class
- 6 min walk test
- key laboratory and iron parameters (including Hb, serum ferritin, TSAT)
- cardiac biomarkers (including NT-proBNP)
- QoL (KCCQ and EQ-5D) questionnaires
- Percentage of patients meeting key safety endpoint defined as time to death, first hospitalization for worsening heart failure, myocardial infarction, angina pectoris and stroke

Änderungen 12 Wochen nach Baseline Visite:
- semi-quantitative Perfusion (Messung im MRT)
- ventrikuläre und arterielle Durchmesser und Wandstärken (Messung durch MRT)
- GFR (durch Radionuklid Messung)
- NYHA-Klasse
- 6 minütiger Geh-Test
- Labor-und Eisen-Parameter (einschließlich Hb, Serum-Ferritin, TSAT)
- kardialen Biomarker (einschließlich der NT-proBNP)
- QoL (KCCQ und EQ-5D) Fragebögen
- Prozent der Patienten, die einen Sicherheitsendpunkt erreichen, wie Zeit bis zum Tod, dem ersten Krankenhausaufenthalt wegen Verschlimmerung der Herzinsuffizienz, Myokardinfarkt, Angina pectoris oder Schlaganfall

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit 3: Week 12 ( day 84 ± 14 days)

Visite 3: Woche 12 (Tag 84 ± 14 Tage)

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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

Yes

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLP

Letzter Besuch letzter Patient

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.1.1.1

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

100

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)

Immediately after individual trial ending (after week 12) patient will be treated routinely for CHF like every other patient in our CHF-out-patient-clinic according to national and international treatment guidelines.

Unmittelbar nach dem Ende der Klinischen Prüfung (Woche 12) werden die Patienten routinemäßig behandelt in unserer CHF-out-Patient-Klinik nach nationalen und internationalen Behandlungsrichtlinien.

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

2012-11-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-10-15

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2014-12-31

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