Clinical Trials Register

Summary
EudraCT Number:	2010-020401-32
Sponsor's Protocol Code Number:	darbepoetina
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2010-09-06
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2010-020401-32

A.3

Full title of the trial

IDENTIFICATION OF OXIDATIVE-STRESS AND MICROINFLAMMATION GENES MODULATED BY ERYTHROPOIETIN ADMINISTRATION IN PATIENTS WITH RENAL TRANSPLANT AND CHRONIC RENAL FAILURE. PERSPECTIVES FOR ERYTHROPOITIN PHARMACOGENOMICS.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

darbepoetina

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

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	AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
B.1.3.4	Country	Italy
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
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	Yes
D.2.1.1.1	Trade name	ARANESP
D.2.1.1.2	Name of the Marketing Authorisation holder	AMGEN DOMPE` SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Darbepoetin alfa
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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

PATIENTS WITH RENAL TRANSPLANT AND CHRONIC RENAL FAILURE

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	SOC
E.1.2	Classification code	10038359

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1) to assess whether ESA treatment may modulate inflammatory and oxidative stress genes in patients with renal transplant; 2) to identify genomic patterns able to explain the complex link among anemia, microinflammation and oxidative stress; 3) to identify ESA unresponsive subjects.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age 18 years or older • Renal transplant > 6 months prior to randomization • Haemoglobin concentration between 11.5 and 12.5 g/dl at Baseline (mean of the two values obtained at week -4 and -2 during screening period)obtained with darbepoetin in the group A (group darbepoetin) and without any eritropoietin in the group B (group untreated) • No ESA therapy during the 3 months prior to randomization • Adequate iron status (serum ferritin =100 ng/mL as well as TSAT =20% or hypochromic red cells <10% if serum transferrin or TIBC are unavailable). The mean of the two values obtained during screening period, at week -4 and -2, should be considered. • GFR (estimated using the aMDRD equation) more then 30 mL/min during screening period (at week -4 and -2).

E.4

Principal exclusion criteria

• Requirement for haemodialysis or peritoneal dialysis therapy within 3 months prior to randomization � mTOR inhibitors (Sirolimus, Everolimus) based Immunosuppression • Change in haemoglobin concentration = 1.5 g/dL during the screening period (week -4 and -2) • Change in GFR >30% during the screening period • Treatment for clinical acute rejection during screening period with GFR stability below 30% • Recipients of other solid organs in addition to kidney • Patients planned to be switched from one immunosuppressive agent to another during study participation • History of positive Anti-phospholipid antibodies • Transfusion of red blood cells during the 3 months prior to randomization • Poorly controlled hypertension as judged by the investigator, or requiring more than 3 antihypertensive drugs (excluding diuretics) • Significant acute or chronic bleeding, such as overt gastrointestinal bleeding, i.e. requiring therapy within 3 months prior to randomization • Active malignant disease (except non-melanoma skin cancer) • Haemolysis • Haemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) • Folic acid deficiency • Vitamin B12 deficiency • Platelet count >500 x 109/L or <100 x 109/L • Pure red cell aplasia • Epileptic seizure in the 6 months prior to randomization • Congestive heart failure (NYHA Class IV) • Myelofibrosis • Active systemic lupus erythematosus • Myocardial infarction or stroke, severe or unstable coronary artery disease, severe liver disease during 3 months prior to randomization • Uncontrolled or symptomatic secondary hyperparathyroidism • Women with positive pregnancy tests prior to randomization • Women of childbearing potential without effective contraception or women in lactation period • Participation in a clinical trial or receipt of investigational compound or treatment within the 3 months prior to randomization • Planned elective surgery during the study period (except cataract surgery, vascular access surgery, urethral stent removal, nephrostomy tube replacement, minor outpatient surgery not requiring hospitalization • Known HIV infection • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

E.5 End points

E.5.1

Primary end point(s)

Changes of the inflammatory and oxidative stress genes in patients with renal transplant with eritropoietin

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

Yes

E.6.11

Pharmacogenomic

Yes

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

E.8.1.2

Open

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

nessun trattamento; se necessario,terapia marziale

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.8.6 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

Information not present in EudraCT

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.1.3	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	Yes
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	20

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

2010-01-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-06-24

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials