Clinical Trials Register

Summary
EudraCT Number:	2006-004606-97
Sponsor's Protocol Code Number:	PMR-EC-1209
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:	2007-02-01
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

2006-004606-97

A.3

Full title of the trial

Estudio multicéntrico, de un solo grupo, abierto de conversión de una pauta inmunosupresora basada en ciclosporina (CyA) a una pauta inmunosupresora basada en la formulación de liberación modificada de tacrolimus, FK506E (MR4), en pacientes trasplantados renales

A.3.2

Name or abbreviated title of the trial where available

CONCERTO

A.4.1

Sponsor's protocol code number

PMR-EC-1209

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	Astellas Pharma GmbH
B.1.3.4	Country	Germany
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	No
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.3.1	Product name	FK506E (MR4)
D.3.2	Product code	FK506E (MR4)
D.3.4	Pharmaceutical form	Prolonged-release capsule, hard
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	tacrolimus
D.3.9.1	CAS number	104987-11-3
D.3.9.2	Current sponsor code	FK506
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	0.5
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	No
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.3.1	Product name	FK506E (MR4)
D.3.2	Product code	FK506E (MR4)
D.3.4	Pharmaceutical form	Prolonged-release capsule, hard
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	tacrolimus
D.3.9.1	CAS number	104987-11-3
D.3.9.2	Current sponsor code	FK506
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	1
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	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	No
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.3.1	Product name	FK506E (MR4)
D.3.2	Product code	FK506E (MR4)
D.3.4	Pharmaceutical form	Prolonged-release capsule, hard
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	tacrolimus
D.3.9.1	CAS number	104987-11-3
D.3.9.2	Current sponsor code	FK506
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	5
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

Se incluirán receptores de trasplante renal adultos estables (al menos 12 meses postrasplante) que están siendo tratados actualmente con ciclosporina y que cumplen los criterios de inclusión y exclusión.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	8.1
E.1.2	Level	LLT
E.1.2	Classification code	10023438
E.1.2	Term	Kidney transplant

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

El objetivo principal es valorar los cambios en la función renal en pacientes trasplantados renales convertidos de una pauta inmunosupresora basada en CyA a una pauta inmunosupresora basada en la formulación de liberación modificada de tacrolimus, FK506E (MR4).

E.2.2

Secondary objectives of the trial

El objetivo secundario es valorar la seguridad y eficacia de una pauta inmunosupresora basada en MR4 en pacientes trasplantados renales convertidos de una pauta inmunosupresora basada en CyA que experimentan efectos secundarios relacionados con CyA.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Edad ≥ 18 años.
2. Trasplante renal al menos 12 meses antes de la inclusión.
3. Tratados con una pauta inmunosupresora basada en CyA desde el último trasplante. La dosis de CyA ha permanecido sin cambios durante las últimas cuatro semanas previas a la inclusión.
4. La pauta inmunosupresora (combinación de medicamentos) ha permanecido sin cambios durante un mínimo de las cuatro semanas previas a la inclusión.
5. Ha experimentado al menos uno de los siguientes acontecimientos adversos relacionados con CyA en la inclusión:
a)Hiperplasia gingival donde, en opinión del investigador, se requiere intervención terapéutica.
b)Hipertricosis / hirsutismo donde, en opinión del investigador, se requiere intervención terapéutica.
c)Hipertensión arterial (con la excepción de nefroesclerosis maligna pretrasplante conocida) estadios I-III (tensión arterial sistólica > 140 mmHg y/o tensión arterial diastólica > 90 mmHg) a pesar del tratamiento con al menos un medicamento antihipertensivo. Los medicamentos antihipertensivos se han prescrito al menos cuatro semanas antes de la inclusión.
d)Hiperlipidemia definida como colesterol total superior a 220 mg/dL a pesar del tratamiento con medicamentos hipolipemiantes, que requiere intervención terapéutica. Los medicamentos hipolipemiantes se han prescrito al menos 4 semanas antes de la inclusión.
6. Creatinina sérica < 200 mol/L (<2,3 mg/dL) en la inclusión.
7. Las pacientes en edad fértil deben tener una prueba de embarazo sérica negativa en la inclusión y deben estar de acuerdo en utilizar de un método anticonceptivo eficaz durante el estudio. El método anticonceptivo eficaz se define como esterilización quirúrgica, anticonceptivos hormonales o abstinencia total en los casos donde el investigador considere que la edad, profesión, estilo de vida u orientación sexual garanticen el cumplimiento por la paciente.
8. El paciente es capaz de entender el propósito y riesgos del estudio, ha sido informado por completo y ha otorgado el consentimiento informado por escrito (se ha obtenido el consentimiento informado por escrito).
9. Clínicamente estable, de acuerdo con el criterio del investigador.

E.4

Principal exclusion criteria

1. Ha recibido previamente el trasplante de un órgano diferente a riñón.
2. Ha sufrido un episodio de rechazo agudo en las 12 semanas previas a la inclusión, o un episodio de rechazo agudo en las 24 semanas previas a la inclusión que requirió terapia con anticuerpos anti-linfocito.
3. Diagnóstico de una nueva neoplasia maligna después del trasplante, con la excepción de carcinoma basocelular o epidermoide de la piel que ha sido tratado con éxito.
4. Glomeruloesclerosis focal segmentaria (FSGS) o glomerulonefritis membranoproliferativa (MPGN) Tipo II como una enfermedad subyacente.
5. Proteinuria > 2 g/24 horas.
6. “Creatinina progresiva” (definida como un aumento del 20% en los seis meses previos a la inclusión y en el Periodo Basal).
7. Niveles elevados de SGPT/ALT y/o SGOT/AST y/o bilirrubina total, ≥ 2 veces el límite superior del intervalo normal del centro de la investigación.
8. Cirrosis hepática.
9. Mujer embarazada o en periodo de lactancia.
10. VIH positivo.
11. Intolerancia o alergia conocida a tacrolimus, antibióticos macrólidos, esteroides, medicación inmunosupresora concomitante adicional o a los excipientes de la medicación del estudio.
12. Cualquier condición médica inestable que, en opinión del investigador, puede interferir con los objetivos del estudio.
13.Está recibiendo tratamiento concomitante prohibido, o ha recibido tratamiento concomitante prohibido en los 28 días previos a la inclusión.
14.Está participando actualmente en otro ensayo clínico, y/o ha recibido un fármaco experimental en los 28 días previos a la inclusión.
15. Cualquier forma de toxicomanía, trastorno psiquiátrico o afección que, en opinión del investigador, puede complicar la comunicación con el investigador.
16. Es improbable que cumpla el calendario de visitas establecido en el protocolo.

E.5 End points

E.5.1

Primary end point(s)

Cambio en el aclaramiento de creatinina, calculado de acuerdo con la fórmula de Cockcroft y Gault, entre el Periodo Basal (Día 1) y la Semana 24 (Fin del Estudio) para cada grupo de efectos secundarios específicos relacionados con CyA (hipertricosis/hirsutismo, hiperplasia gingival, hiperlipidemia e hipertensión arterial.

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Conversión de un solo grupo

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

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

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

372

F.4.2.2

In the whole clinical trial

380

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)

Una vez que el paciente ha completado o se ha retirado del estudio, el tratamiento inmunosupresor que se utilice a continuación se ajustará al criterio del investigador. Los pacientes que hayan recibido al menos una dosis de MR4 pueden continuar con MR4 en un estudio de extensión FG-506E-14-02 hasta que FK506E (MR4) se comercialice.

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

2007-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-03-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-04-16

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