Clinical Trials Register

Summary
EudraCT Number:	2016-000992-26
Sponsor's Protocol Code Number:	VAPOR002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-02-20
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

Spain - AEMPS

A.2

EudraCT number

2016-000992-26

A.3

Full title of the trial

Volatile Anesthetic Protection Of Renal transplants 2

ANESTÉSICOS VOLÁTILES COMO PROTECTORES EN EL TRASPLANTE RENAL-2

A.3.1

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

Volatile Anesthetic Protection Of Renal transplants

ANESTÉSICOS VOLÁTILES COMO PROTECTORES EN EL TRASPLANTE RENAL

A.4.1

Sponsor's protocol code number

VAPOR002

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	University Medical Center Groningen
B.1.3.4	Country	Netherlands
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	university medical center groningen
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación Puigvert
B.5.2	Functional name of contact point	Unid. coordinación ensayos clínicos
B.5.3	Address:
B.5.3.1	Street Address	C/ Cartagena, 340-350
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08025
B.5.3.4	Country	Spain
B.5.4	Telephone number	0349341697004589
B.5.5	Fax number	034934169719
B.5.6	E-mail	isilva@fundacio-puigvert.es

D. IMP Identification
D.IMP: 1
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	Propofol
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Deutschland GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Propofol
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 drip use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	propofol
D.3.9.1	CAS number	2078-54-8
D.3.9.3	Other descriptive name	PROPOFOL
D.3.9.4	EV Substance Code	SUB10116MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	2.5
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)	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.IMP: 2
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	sevoflurane
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	sevoflurane
D.3.4	Pharmaceutical form	Inhalation vapour, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sevoflurane
D.3.9.1	CAS number	28523-86-6
D.3.9.3	Other descriptive name	SEVOFLURANE
D.3.9.4	EV Substance Code	SUB10506MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	up to
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)	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

kidney transplantation

trasplante de riñón

E.1.1.1

Medical condition in easily understood language

kidney transplantation

trasplante de riñón

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

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 compare the effect of a sevoflurane based anesthesia versus a propofol based anesthesia on acute rejection in recipients of living, DCD and DBD donor kidneys

Comparar el efecto de una pauta anestésica con sevoflurano versus
una basada en propofol en cuanto a la incidencia en el retraso de la
función renal en receptores renales de donante fallecido y donante
a corazón parado

E.2.2

Secondary objectives of the trial

- To compare GFR on 3, 6 and 12 months between a sevoflurane based anesthesia versus a propofol based anesthesia .

Comparar la TFG a los 3, 6, y 12 meses entre una anestesia basada en sevoflurano y una anestesia basada en propofol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients scheduled for kidney transplantation with a kidney from a living, DBD or DCD donor
Age > 18 years
Written informed consent

-Pacientes que van a recibir un trasplante renal y que son >18 años.
-Pacientes que firman el consentimiento informado para participar en el ensayo.

E.4

Principal exclusion criteria

high immunological risk as determined by local practice
Patients of the ABO-incompatible program

-Pacientes con un alto riesgo inmunológico determinado según la
práctica clínica habitual del centro.
-Pacientes que están dentro del programa de trasplante ABO -
incompatible.

E.5 End points

E.5.1

Primary end point(s)

The Kaplan-Meier method will be used to analyze acute rejection episodes. Differences between the curves were determined with the log-rank test

El método de Kaplan-Meier se utilizará para analizar los episodios de rechazo agudo. Las diferencias entre las curvas se determinaron con la prueba log-rank

E.5.1.1

Timepoint(s) of evaluation of this end point

1 year after transplantion

1 año después del transplante

E.5.2

Secondary end point(s)

Differences between groups with respect to categorical data will be tested by Chi-square or Fisher’s exact tests. Continuous data will be tested for normality with the use of Kolmogorov-Smirnov. In case of normality t-tests will be used. If not Mann-Whitney tests will be applied.. Values are given as mean with standard deviation (SD) or median with interquartile range (IQR). Regarding biomarkers, for each recipient and each biomarker an area under the curve (AUC) will be calculated. When values in the midde are missing, linear interpolation will be applied. When values at the beginning or end are missing value next in line will be used instead. When more than one value is missing in the same patient, this patient will be excluded AUC’s will be analysed with t-test or Mann-whitney
The repeated measurements on GFR at 1, 3, 6 and 12 months analysis will be performed using a mixed effect model

Las diferencias entre los grupos con respecto a los datos categóricos se probarán por Chi-cuadrado o las pruebas exactas de Fisher. Los datos continuos serán probados para la normalidad con el uso de Kolmogorov-Smirnov. En caso de normalidad se utilizarán las pruebas t. Si no se aplican las pruebas de Mann-Whitney. Los valores se dan como media con desviación estándar (SD) o mediana con rango intercuartílico (IQR). Con respecto a los biomarcadores, para cada receptor y cada biomarcador se calculará un área bajo la curva (AUC). Cuando faltan valores en el midde, se aplicará interpolación lineal. Cuando los valores al principio o al final falten, el valor siguiente en la línea se utilizará en su lugar. Cuando falte más de un valor en el mismo paciente, este paciente será excluido. Las AUC serán analizadas con t-test o Mann-whitney
Las mediciones repetidas de GFR a los análisis de 1, 3, 6 y 12 meses se realizarán usando un modelo de efecto mixto

E.5.2.1

Timepoint(s) of evaluation of this end point

1 year after transplantion

1 año después del transplante

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

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

Yes

E.8.1.4

Double blind

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)

Yes

E.8.2.2

Placebo

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

12 months after the last patient is included in the study

12 meses después de la inclusión del último paciente en el estudio

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:

450

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

520

F.4.2.2

In the whole clinical trial

520

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)

none

ninguno

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

2017-05-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-25

P. End of Trial
P.	End of Trial Status	Ongoing

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