Clinical Trials Register

Summary
EudraCT Number:	2012-003815-71
Sponsor's Protocol Code Number:	AK-1-2012
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-02-04
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

Denmark - DHMA

A.2

EudraCT number

2012-003815-71

A.3

Full title of the trial

The effect of furosemide on fluid volumes
and biomarkers in urine for measurement of sodium and water channel activity in healthy subjects

Effekten af furosemid på væskevoluminer
og biomarkører i urin til måling af natrium og vandkanal aktiviteten hos raske forsøgspersoner

A.3.1

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

The effect of furosemide on fluid volumes
and biomarkers in urine for measurement of sodium and water channel activity in healthy subjects

Effekten af furosemid på væskevoluminer
og biomarkører i urin til måling af natrium og vandkanal aktiviteten hos raske forsøgspersoner

A.4.1

Sponsor's protocol code number

AK-1-2012

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	Department of Medical Research
B.1.3.4	Country	Denmark
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	Private and public funding
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Holstebro Hospital
B.5.2	Functional name of contact point	Department of Medical Research
B.5.3	Address:
B.5.3.1	Street Address	Laegaardvej 12
B.5.3.2	Town/ city	Holstebro
B.5.3.3	Post code	7500
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4578436589
B.5.6	E-mail	aocza@hotmail.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	Furix 10 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Nycomed Danmark Langebjerg 1 4000 Roskilde
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	furix
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	FUROSEMIDE
D.3.9.1	CAS number	54-31-9
D.3.9.2	Current sponsor code	AK-1-2012
D.3.9.4	EV Substance Code	SUB07849MIG
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	10
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	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

healthy people

raske personer

E.1.1.1

Medical condition in easily understood language

healthy people

raske personer

E.1.1.2

Therapeutic area

Body processes [G] - Physiological processes [G07]

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	10049506
E.1.2	Term	Investigation NOS
E.1.2	System Organ Class	100000004848

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 purpose is to measure the effect of intravenous furosemide administration on changes in volume status via whole body bioimpedance spectroscopy (ICV, ECV, TBV, ECV / ICV)

Formålet er at måle effekten af intravenøst furosemid indgift på ændringer i volumenstatus via helkrops bioimpedans spectroscopy (ICV, ECV, TBV, ECV/ICV);

E.2.2

Secondary objectives of the trial

The purpose is to measure the effect of intravenous furosemide administration on renal treatment of sodium and water ( u-AQP2, u-ENAC, u-NCC, u-NKCC2, GFR, CH2O, FENA; plasma concentrations of vasoactive hormones (PRC, p-Ang II, p-ALDO, p-AVP, p-ANP and BNP p); central blood pressure (CBT), endothelbundet glycokalyx (p-syndecan-1)

Formålet er at måle effekten af intravenøst furosemid indgift på nyrernes behandling af natrium og vand ved måling af u-AQP2, u-ENaC , u- NCC, u-NKCC2, GFR, CH2O, FENa; plasmakoncentration af vasoaktive hormoner med betydning for regulering af natrium- og vandbalancen (PRC, p-Ang II, p-Aldo, p-AVP, p-ANP og p-BNP); centralt blodtryk (cBT); påvirkning af endothelbundet glycokalyx (p-syndecan-1

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Healthy volunteer men and women.
Age 18 - 45 years.
BMI within the normal range, ie. between 18.5 to 30.0 kg/m2
Fertil women must use effective contraception

Raske frivillige mænd og kvinder.
Alder 18 – 45 år.
BMI indenfor normalområde, dvs. mellem 18,5- 30,0 kg/m2
Fertile kvinder skal anvende sikker antikonception

E.4

Principal exclusion criteria

Arterial hypertension, ie. ambulatory blood pressure> 130 mmHg systolic and / or 80 mmHg diastolic.
A history or clinical evidence of significant cardiac, pulmonary, hepato, renal, endocrine, cerebral and neoplastic disorders.
Alcohol and Substance Abuse.
Medical treatment apart from oral contraceptives.
Smoking.
Pregnancy or breast-feeding.
Lack of desire to participate.
Blood Donation within the last month
abnormal blood tests
Allergy above one of the ingredients of the study drug

Arteriel hypertension, dvs. døgnblodtryk >130 mmHg systolisk og/eller 80 mmHg diastolisk.
Anamnestiske eller kliniske tegn på betydende cardielle, pulmonale, hepato, renale, endokrine, cerebrale eller neoplastiske lidelser.
Alkoholmisbrug og Stofmisbrug.
Medicinsk behandling fraset orale antikonceptiva.
Rygning.
Graviditet eller amning.
Manglende ønske om at deltage.
Bloddonation indenfor den seneste måned inden undersøgelsesdagen i første forsøgssekvens.
Abnorme blodprøver
Allergi ovenfor et af indholdsstofferne i forsøgsmedicinen

E.5 End points

E.5.1

Primary end point(s)

Extracellular volumen ECV

Ekstracellulear volumen ECV

E.5.1.1

Timepoint(s) of evaluation of this end point

end of trial

afslutning

E.5.2

Secondary end point(s)

Intracellular volume( ICV), total body water( TBW), central BP, arteriel stiffness( Pulse wave velocity), plasma concentrations of angiotensin II, aldosteron, vasopressin, syndecan, P-ANP og P-BNP, free water clearance ( CH2O), GFR, protein excretion from epithelial sodium channels ( u- EnaC, u-NKCC, u-NCC) and aquaporins(u-AQP2), fractional excretion of sodium ( FENa)

ICV; ECV/ICV; TBW
U-NKCC, u-ENaC, u-NCC, FENa, Diurese, CH2O
PRC, p-Ang II, p-Aldo, p-AVP, p-syndecan 1, p-ANP og p-BNP
CBT, PWV, AI

E.5.2.1

Timepoint(s) of evaluation of this end point

end of study

afslutning

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

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)

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

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

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

the end of the last visit of the last subject

sidste forsøgspersons sidste besøg

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)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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

F.4.2.2

In the whole clinical trial

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

ingen

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

2012-11-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-02-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-09

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