Clinical Trials Register

Summary
EudraCT Number:	2011-004273-88
Sponsor's Protocol Code Number:	ASK-1-2011
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2011-09-08
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

2011-004273-88

A.3

Full title of the trial

Effect of hydroxyethyl starch on renal handling of sodium and water, vasoactive hormones,biomarkers and the circulatory system in patients undergoing laparoscopic nephrectomy

Effekten af hydroxyethyl stivelse på nyrernes behandling af natrium og vand, vasoaktive hormoner, biomarkører og kredsløbet hos patienter, der undergår laparoskopisk nefrektomi

A.3.1

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

Effect of hydroxyethyl starch on renal handling of salt and water, blood pressure-regulating hormones, proteins and circulatory system of patients undergoing kidney removal by keyhole surgery

Effekten af hydroxyethyl stivelse på nyrernes behandling af salt og vand, blodtryksregulerende hormoner, proteiner og kredsløbet hos patienter, der får fjernet en nyre med kikkertoperation

A.3.2

Name or abbreviated title of the trial where available

Hydroxyethyl starch and renal function after laparoscopic nephrectomy

Hydroxyethyl stivelse og nyrefunktion efter laparoskopisk nefrektomi

A.4.1

Sponsor's protocol code number

ASK-1-2011

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	Erling Bjerregaard Pedersen, Medicinsk forskningsafsnit, Regionshospitalet Holstebro
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	Medicinsk forskningsafsnit, Regionshospitalet Holstebro
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Anæstesiologisk afdeling, Regionshospitalet Holstebro
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Regions Midts sundhedsvidenskabelige forskningsfond
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	Regionshospitalet Holstebro
B.5.2	Functional name of contact point	Medicinsk forskningsafsnit
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	+457843 6586
B.5.5	Fax number	+457843 6582
B.5.6	E-mail	annekanc@rm.dk

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	Voluven 60 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresinus Kabi
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	Hydroxyethyl starch
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
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 infusion
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

Patients undergoing laparoscopic nefrectomy in generel anesthesia

Patienter, der undergår laparoskopisk nefrektomi i generel anæstesi

E.1.1.1

Medical condition in easily understood language

Patients undergoing kidney removal by keyhole surgery under anesthesia

Patienter, der får fjernet en nyre med kikkertoperation i fuld bedøvelse

E.1.1.2

Therapeutic area

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

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	10037775
E.1.2	Term	Radical nephrectomy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 objective is for elective laparoscopic nephrectomy to measure the effect of hydroxyethyl starch on biomarkers of nephrotoxicity (U-Alb, u- NGAL, u-Kim 1, u-FABP)

Formålet er i forbindelse med elektiv laparoskopisk nefrektomi at måle effekten af hydroxyethylstivelse på biomarkører for nefrotoksicitet (u-Alb, u-N-GAL, u-Kim 1, u- FABP)

E.2.2

Secondary objectives of the trial

Secondarily to measure the effect of hydroxyethyl starch on the renal tubular transport of sodium and water (FENa, u-ENaCβ, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoactive hormones (PRC, p-Ang-II, p -Aldo, p-ANP, P-GDP, p-AVP, p-Endot) and central hemodynamics (SBP, DBP, heart rate) during elective laparoscopic nephrectomy

Sekundært for at måle effekten af hydroxyethylstivelse på den renale tubulære transport af natrium og vand (FENa, u-ENaCβ, CH2O, u-AQP2, u-NCC, u-NK2CC), vasoaktive hormoner (PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, p-Endot) og central hæmodynamik (SBP, DBP, hjertefrekvens) i forbindelse med elektiv laparoskopisk nefrektomi

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age > 18 years
- Males and females
- Indication for laparoscopic nephrectomy OR
- Indiction for laparoscopic partial removal of the kidney OR
- Indication for laparoscopic glandel stageing

- Alder > 18
- Mænd og kvinder
- Indikation for laparoskopisk nefrektomi ELLER
- Indikation for laparoskopisk partiel fjernelseaf nyren ELLER
- Indikation for laparoskopisk glandel stageing

E.4

Principal exclusion criteria

- Blooddonation within the last month
- Lack of wish to participate
- eGFR< 15ml/min
- pregnancy or breast feeding

- Bloddonation inden for en måned inden operationen.
- Manglende lyst til at deltage
- eGFR < 15 ml/min
- graviditet eller amning

E.5 End points

E.5.1

Primary end point(s)

u- NGAL

E.5.2

Secondary end point(s)

PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, p-Endot, CH2O, u-AQP2, FENa u- EnaCβ, u-Alb, u-Kim 1, u-FABP, u-NCC, u-NK2CC, heart rate, SBP and DBP

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

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.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

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

Last visit of the last subject

Sidste besøg af den sidste forsøgsperson

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
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	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	40
F.4.2	For a multinational trial
F.4.2.1	In the EEA	40
F.4.2.2	In the whole clinical trial	40

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

2011-09-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-21

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2014-09-29

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