Clinical Trials Register

Summary
EudraCT Number:	2011-002518-35
Sponsor's Protocol Code Number:	2011-402
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:	2012-02-01
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

2011-002518-35

A.3

Full title of the trial

The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantation

A.3.1

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

The effect of aldosterone on the development of chronic allograft nephropathy after kidney transplantation

A.3.2

Name or abbreviated title of the trial where available

CODE-CAN

A.4.1

Sponsor's protocol code number

2011-402

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	Karl Emil Kristensen
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Rigshospitalet, Dept. of Nephrology
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Blegdamsvej 9, afsnit 2132
B.5.3.2	Town/ city	Copenhagen, east
B.5.3.3	Post code	2100
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004526858717
B.5.5	Fax number	004535452240
B.5.6	E-mail	karlemil@dadlnet.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	inspra
D.2.1.1.2	Name of the Marketing Authorisation holder	pfizer
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Gastroenteral use Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EPLERENONE
D.3.9.1	CAS number	107724-20-9
D.3.9.3	Other descriptive name	EPLERENONE
D.3.9.4	EV Substance Code	SUB06574MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
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)	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	Furix
D.2.1.1.2	Name of the Marketing Authorisation holder	Nycomed Denmark
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.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
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	FUROSEMIDE
D.3.9.1	CAS number	54-31-9
D.3.9.3	Other descriptive name	FUROSEMIDE
D.3.9.4	EV Substance Code	SUB07849MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	20
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

Chronic allograft nephropathy in kidney transplants, defined as tubular atrophy and interstitial fibrosis in graft biopsy (Banff criteria)

kronisk allograft nefropati

E.1.1.1

Medical condition in easily understood language

The slowly loss of kidney function after kidney transplatation due to chronic scarring of the kidney tissue

langsom tab af graft funktion efter nyretransplantation grundet arvævsdannelse i nyrevævet

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10063209
E.1.2	Term	Chronic allograft nephropathy
E.1.2	System Organ Class	10022117 - Injury, poisoning and procedural complications

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 examine the possible renal graft protective effects of treatment with eplerenone in kidney transplanted patients in addition to a standard regimen, including studies in the progression of proteinuria and glomerular filtration.

At undersøge effekten af eplerenon som tillæg til standard behandlingsregime efter nyretransplantation. Dette i forhold til reduktion af proteinuri samt ændring i den glomerulære filtrationsratio (GFR)

E.2.2

Secondary objectives of the trial

to reduce the velocety at witch the graft function is declining

at reducerer hastigheden hvormed funktionen af nyregraften aftager

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All the criteria must be fulfilled for inclusion

•Men and women of 18 years or more, transplanted with a kidney from diseased or living donor, for between 1 and 3 years ago. Kidney function must be stable with a creatinine clearance at 30 ml/min or more.

• Patients who have read and understood the conditions of participation of the study, as described in the patient information.

• Patients, who can give an informed consent in regard to the patient information.

•Patients, who are not expelled by the exclusion criteria.

Alle kriterier skal være opfyldt for inklusion

• Mænd og kvinder, 18 år eller der over, dog ikke ældre end 70 år, som er blevet transplanteret med nyrer fra afdøde eller levende donorer, for mellem 1 og 5 år siden. creatininclearance ≥ 20 ml/min, < 60 ml/min.
• Patienter, der har læst og forstået vilkårene for deltagelse i studiet, som de står beskrevet i patientvejledningen.
• Patienter, som kan indgå et informeret samtykke på baggrund af patientvejldningen.
• Patienter, som ikke ekskluderes af eksklusionskriterierne.

E.4

Principal exclusion criteria

•Patients, who are pregnant and/or breastfeeding or fertile women, who are not prepared to use safe contraceptives (P-pills, hormone spiral or depot gestagene) during the time of the investigation. Pregnancy should be ruled out in fertile women by a negative pregnancy tests or the use of safe contraceptive for at least 3 months before study entry.

• Patients, who are HIV, HBV, HCV positive or suffer of other serious diseases.

•Patients with diarrhea or gastrointestinal illness, which can prevent adequate absorption of the study drugs.

•Patients with malignant diseases, except local dermal carcinoma, treated with success.

•Patients with active systemic infections.

•Patients with other chronic or acute, systemic or organ specific diseases, which are debilitating the patient, in such a way, that study entry cannot be defended by the investigating doctors.

•Patients with plasma potassium > 6,5 mmol/l

•Patients, with any form of abuse of medical products, psychiatric disorders or other diseases, which may hamper the contacts between patient and the doctors.

•Patients, enrolled in other projects involving administration of project medication or other treatment, which may affect the outcome.

•Patients with allergic sensitization against the investigated drugs.

•Patients treated with m-TOR blockade (sirolimus, everolimus)

• Patienter, som er gravide, ammer eller som, når det drejer sig om fertile kvinder, ikke er villige til at anvende sikre svangerskabsforebyggende midler (p-piller, hormonspiral eller depotgestagen) i den tid undersøgelsen foregår. Graviditet skal udelukkes hos fertile kvinder med negativ graviditetstest eller anvendelse as sikker kontraception i mindst 3 måneder op til indtræden i studiet.
• Patienter, der er positive for HIV, HTLV1, HVB eller anden potentiel alvorlig infektionssygdom.
• Patienter med diarre eller gastrointestinal lidelse, som kan forhindre optaget af de farmaka som indgår i studiet.
• Patienter med maligne sygdomme. Ikke metastaserende hudcarcinom, som med succes er behandlet er fritaget fra dette kriterium.
• Patienter med aktive systemiske infektioner Patienter med anden kronisk eller akut, systemisk eller organspecifik sygdom, som er invaliderende på en sådan måde, at indgang i studiet ikke kan forsvares, skønnet af den undersøgende læge.
• Patienter med hyperkaliæmi plasma kalium > 6,5 mmol/l
• Patienter med enhver form for medicinmisbrug, psykiatrisk lidelse eller andre sygdomme, som efter undersøgerens mening kan vanskeliggøre kontakten mellem patient og de involverede læger.
• Patienter, som indgår i andre projektstudier der indebærer indgift af projektmedicin eller anden behandling, der kan påvirke undersøgelsens udfald.
• Patienter med overfølsomhed overfor de undersøgte præparater.
• Patienter i immunosupressiv behandling med m-TOR blokade (sirolimus og everolimus)

E.5 End points

E.5.1

Primary end point(s)

Primary endoints.
24 hour urine albumine excretion

døgnurinalbuminudskillelse

E.5.1.1

Timepoint(s) of evaluation of this end point

The primery endpoint will be evaluated at 3 months and one year after initiation

efter 3 måneder og efter 1 år

E.5.2

Secondary end point(s)

Ethiological studies in CAN:
• The ekspression of CYP11B2
• The ekspressionen PAI-1, TGF-β,

surrogat messures of CAN
• Chrome EDTA clearance/Technetium DTPA renography
• Blood pressure
• weight

ætiologiske studier i can
• ekspressionen af CYP11B2
• ekspressionen PAI-1, TGF-β, og radical
surrogate mål for CAN
• Chrome EDTA clearance/Technetium DTPA renografi
• blodtryk
• vægt

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary endpoints regarding ethiological reseach will be evaluated one at initiation.
Secondary endpoints regarding surrogate endpoint will be evaluated at week 0, 12, 26, 48.

ætiologiske studier af CAN evalueres ved indgang til studiet
andre sekundære endepunkter evalueres til tiderne
0, 12, 26, 48 uger.

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

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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.8.2.3.1

Comparator description

Furix

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

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	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.1.2.1	Number of subjects for this age range:	60
F.1.3	Elderly (>=65 years)	No
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	60
F.4.2	For a multinational trial
F.4.2.1	In the EEA	60
F.4.2.2	In the whole clinical trial	60

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

2012-02-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-22

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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