Clinical Trials Register

Summary
EudraCT Number:	2009-015579-28
Sponsor's Protocol Code Number:	FER-CKD-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-11-25
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

Spain - AEMPS

A.2

EudraCT number

2009-015579-28

A.3

Full title of the trial

Estudio abierto, multicéntrico, aleatorizado y de 3 grupos paralelos para comparar la eficacia y la seguridad de la carboximaltosa férrica por vía intravenosa (regímenes en dosis bajas y altas de Ferinject®) con las del hierro por vía oral en el tratamiento de la anemia ferropénica en pacientes con nefropatía crónica sin diálisis.

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

A.3.2

Name or abbreviated title of the trial where available

The FIND-CKD Trial

A.4.1

Sponsor's protocol code number

FER-CKD-01

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Vifor Pharma 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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®
D.2.1.1.2	Name of the Marketing Authorisation holder	Vifor France SA
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Intravenous infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Carboximaltosa férrica (CMF)
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 2
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®
D.2.1.1.2	Name of the Marketing Authorisation holder	Vifor France SA
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Intravenous infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Carboximaltosa férrica (CMF)
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Plastufer®
D.2.1.1.2	Name of the Marketing Authorisation holder	MEDA Pharma GmbH & Co. KG
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	Capsule, soft
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sulfato ferroso (III)
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	304.3
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Anemia ferropénica en pacientes con nefropatía crónica sin diálisis

Iron deficiency anaemia in subjects with non-dialysis-dependent chronic kidney disease

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10064848
E.1.2	Term	Chronic kidney disease

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10022972
E.1.2	Term	Iron deficiency anaemia

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluar la eficacia a largo plazo de la CMF (determinación de la dosis mediante el uso de concentraciones de ferritina objetivo) o del hierro por vía oral para retrasar o reducir el consumo de medicamentos estimuladores de la eritropoyesis (MEE) o el uso de otras opciones para tratar la anemia en pacientes con NC-SD y anemia ferropénica (AF).

E.2.2

Secondary objectives of the trial

-Evaluar el potencial para reducir la necesidad de MEE en los pacientes que reciben CMF (determinación de la dosis mediante el uso de concentraciones de ferritina objetivo) o hierro por vía oral.
-Evaluar la seguridad y la tolerabilidad a largo plazo de Ferinject y del hierro por vía oral en el tratamiento de los pacientes con NC-SD y AF.
?Evaluar la utilización de recursos sanitarios, los efectos sobre la calidad de vida (CdV) y la carga económica del tratamiento de los pacientes con NC-SD y AF.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Al menos 18 años de edad.
2.Pacientes con NC-SD y una filtración glomerular estimada (FGe) ≤ 60 ml/min/1,73 m2 determinada mediante la fórmula MDRD (modification of diet in renal disease).
3.Pacientes con NC-SD y una pérdida de FGe ≤ 12 ml/min/1,73 m2 por año (a tenor de al menos 2 valores obtenidos durante 4 semanas como mínimo, preferiblemente 3 valores obtenidos durante 3 meses como mínimo) y una FGe teórica ≥ 15 ml/min/1,73 m2 en 12 meses (según la pérdida de FGe anterior).
4.Hb en la selección de entre 9 y 10,5 g/dl según un promedio de al menos 2 valores de Hb obtenidos durante el período de selección (y el día de la aleatorización) con un mínimo de 2 días y un máximo de 4 semanas entre la obtención de los valores (sin ningún valor individual ≥ 12 g/dl).
5.Ferritina en la selección < 100 mcg/l.
6. Sin tratamiento previo con MEE (sin exposición previa).
7. Las mujeres en edad fértil deben presentar una prueba de embarazo en orina negativa en la selección.
8. Antes de realizar ningún procedimiento específico del estudio debe obtenerse el consentimiento informado por escrito pertinente.

E.4

Principal exclusion criteria

1. Antecedentes de sobrecarga de hierro adquirida.
2. Hipersensibilidad conocida a alguno de los componentes del sulfato ferroso o CMF. Nota: podrán participar los pacientes con hipersensibilidad a otras formas de hierro.
3. Antecedentes documentados de suspensión del tratamiento con productos derivados del hierro debido a molestias digestivas significativas.
4. SATT en la selección > 40%.
5. Infección activa conocida, proteína C reactiva > 20 mg/l, hemorragia manifiesta clínicamente importante, neoplasia maligna activa.
6. Antecedentes de alcoholismo crónico (consumo de alcohol > 40 g/día).
7. Hepatopatía crónica o concentraciones de alanina transaminasa o aspartato transaminasa en la selección más de 3 veces por encima del límite superior del intervalo normal.
8. Infección por el virus de la inmunodeficiencia humana/síndrome de inmunodeficiencia humana conocido, infección por el virus de la hepatitis B o C.
9. Anemia debida a otras causas diferentes de la ferropenia (p. ej., hemoglobinopatía). Se permitirá la inclusión de pacientes con deficiencia de vitamina B12 o ácido fólico tratada.
10. Administración intravenosa de hierro o transfusiones de sangre en las 12 semanas anteriores a la selección.
11.Tratamiento con hierro por vía oral en las 4 semanas anteriores a la selección.
12.Tratamiento inmunodepresor.
13.Diálisis renal.
14.Diálisis o trasplante previsto durante el estudio.
15. Necesidad prevista de una intervención quirúrgica que pueda provocar una hemorragia significativa (> 100 ml).
16. Padecimiento actual de insuficiencia cardíaca crónica en clase IV según la New York Heart Association (NYHA).
17. Hipertensión arterial con control deficiente (> 160/100 mm Hg).
18.Síndrome coronario agudo o accidente cerebrovascular en los 3 meses anteriores a la selección.
19.Padecimiento actual de trastornos psiquiátricos graves u otras enfermedades concomitantes que, a criterio del investigador, hacen que la participación sea inaceptable.
20.La paciente no utiliza métodos anticonceptivos adecuados. Los métodos anticonceptivos adecuados se definen como aquellos que deparan una tasa de fracaso baja (es decir, menos del 1% por año) si se utilizan de forma constante y correcta, como implantes, productos inyectables, anticonceptivos orales combinados, algunos dispositivos intrauterinos, abstinencia sexual o pareja vasectomizada. La edad no fértil incluye la esterilización quirúrgica al menos 6 meses antes del estudio o la posmenopausia, definida como la presencia de amenorrea durante un mínimo de 12 meses.
21.Paciente en edad fértil con evidencia de embarazo (p. ej., prueba de gonadotropina coriónica humana positiva) o en período de lactancia.
22. Body weight <35 kg.
22.Peso corporal < 35 kg.
23.El paciente participa actualmente en otro estudio de un dispositivo o medicamento en investigación, o aún no han transcurrido 30días desde su finalización, o está recibiendo otro medicamento en investigación.
24.El paciente no estará disponible para la evaluación de seguimiento.
25.El paciente presenta algún tipo de trastorno que compromete su capacidad para otorgar su consentimiento informado por escrito o para cumplir los procedimientos del estudio.

E.5 End points

E.5.1

Primary end point(s)

Criterio de valoración principal de la eficacia:
-Tiempo hasta el inicio de otro tratamiento de la anemia (p. ej., MEE o transfusión) determinado mediante análisis de supervivencia de Kaplan-Meier.

Criterios de valoración secundarios:
-Necesidad acumulada de MEE a lo largo del período de estudio.
?Porcentaje de pacientes que requieran transfusiones en cualquier momento del estudio.
-Necesidad acumulada de hierro y número de administraciones de hierro a lo largo del período de estudio.

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

230

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

Information not present in EudraCT

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

E.8.7

Trial has a data monitoring committee

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

At week 56 (or 4 weeks after last dose of study medication if subject is withdrawn early) all assessments per Schedule of Events should be completed.
En la semana 56 (o 4 semanas después de la última dosis del medicamento del estudio si el paciente es retirado prematuradamente) todos

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

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1000

F.4.2.2

In the whole clinical trial

1016

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)

If additional/new anaemia management is required, subjects should continue to follow the protocol Schedule of Events for assessments; however, therapy would be at discretion of the treating physician (this may include the use of iron (in any form) or other methods of anaemia management with or without iron replacement therapies).

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

2010-02-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-02-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-02-12

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IMP with orphan designation in the indication
Orphan Designation Number:
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