Clinical Trials Register

Summary
EudraCT Number:	2020-002956-20
Sponsor's Protocol Code Number:	FerinjectFPG2020
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-06
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002956-20

A.3

Full title of the trial

Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.

Studio FERIE: studio di efficacia del ferro carbossimaltosio nel paziente trapiantato di rene

A.3.1

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

Prospective, interventional, open-label single center pilot study to evaluate FERInject Efficacy in 20 maintenance kidney transplant recipients.

A.3.2

Name or abbreviated title of the trial where available

FERIE

A.4.1

Sponsor's protocol code number

FerinjectFPG2020

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	FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
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	Vifor Pharma Group
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Direzione scientifica Fondazione Policlinico A.Gemelli IRCCS
B.5.2	Functional name of contact point	Direzione Scientifica Fondazione Po
B.5.3	Address:
B.5.3.1	Street Address	Largo Agostino Gemelli 8
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630155701
B.5.5	Fax number	0630155701
B.5.6	E-mail	direzione.scientifica@policlinicogemelli.it

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	FERRO-GRAD - 105 MG COMPRESSE A RILASCIO PROLUNGATO 40 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	TEOFARMA S.R.L.
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.3.1	Product name	FERRO-GRAD
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Prolonged-release 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	FERRO SOLFATO
D.3.9.1	CAS number	7782-63-0
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	105
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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	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	FERINJECT - 50 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE 5 FLACONCINI IN VETRO DA 2 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	VIFOR FRANCE SA
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.3.1	Product name	FERINJECT
D.3.2	Product code	[NA]
D.3.4	Pharmaceutical form	Solution for 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	FERRO CARBOSSIMALTOSIO
D.3.9.1	CAS number	9007-72-1
D.3.9.2	Current sponsor code	NA
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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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

This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.

Il presente studio è rivolto a pazienti trapiantati di rene con malattia renale cronica, deficit marziale e anemia.

E.1.1.1

Medical condition in easily understood language

This study is aimed at kidney transplant recipient with chronic kidney disease, iron deficiency and anemia.

Il presente studio è rivolto a pazienti trapiantati di rene con malattia renale cronica, deficit marziale e anemia.

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10050308
E.1.2	Term	Iron replacement
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary: To evaluate Ferric Carboxymaltose efficacy to improve anemic status in post-transplant CKD patients.

Obiettivo principale del presente studio è valutare la capacità del FCM nel migliorare lo stato anemico in pazienti con CKD trapiantati di rene.

E.2.2

Secondary objectives of the trial

Secondary: To define a clinical approach for iron supplementation and ESA management in CKD kidney transplant recipients.

Obiettivo secondario sarà quello di definire un approccio clinico alla supplementazione marziale e alla gestione degli ESA nei pazienti trapiantati di rene con malattia renale cronica.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: TRANSLATIONAL APPROACH TO IRON DEFICIENCY (v 1.0 2020 June 01)
pag. 5 Protocol

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Approccio Traslazionale alla carenza marziale (v 1.0 2020 June 01)
pag. 3 Sinossi

E.3

Principal inclusion criteria

Inclusion criteria for Baseline visit
1. Age > 18 years
2. Transplant vintage > 3 months (living or deceased, useful subpopulation)
3. In active ESA therapy (last ESA dose within 6 weeks before screening)
4. GFR between 30 and 60 ml/min/1.73 m2 according to CKD-EPI equation
5. Anemia with hemoglobin between 8-12 g/dl ,
6. TSAT < 30% and Ferritin < 300 ug/L (6)
7. Patient able to understanding and sign an informed consent

Criteri di inclusione alla visita Baseline:
• Età > 18 anni;
• Trapianto di rene effettuato da più di 3 mesi;
• In terapia con ESA attiva (ultima dose somministrata entro 6 settimane dallo screening)
• GFR tra 30 and 60 ml/min/1.73 m2 secondo la formula CKD-EPI
• Anemia con emoglobina compresa tra 8-12 g/dl
• TSAT < 30% e Ferritina < 300 ug/L
• Paziente in grado di comprendere e firmare il consenso informato

E.4

Principal exclusion criteria

1. Need for HD
2. Active bleeding
3. Recent transfusion (within 30 days before screening) or need for transfusion
4. Patients currently in therapy with ferric carboxymaltose (last dose within 60 days before screening)
5. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days before screening.
6. Patient is unlikely to comply with the visits scheduled in the protocol
7. Female patients of childbearing potential, which do not want to maintain effective birth control, practice during the study and 3 months thereafter.
8. Female patients pregnant or during feeding time.
9. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication with the investigator.
10. Known hypersensitivity to iron sulfate, ferric carboxymaltose, foline or one of the excipients.
11. Evidence of iron overload or excessive accumulation of iron (hemochromatosis, chronic hemolysis)
12. Disorders of iron metabolism (sideroacrestical anemias, sideroblastic anemia, saturnine anemia, thalassemia).
13. Anemia not attributable to iron deficiency and CKD, e.g. other microcytic anemia.
14. Previous adverse events following iron administration.
15. Patients with LES, Rheumatoid Arthritis, allergic asthma, liver diseases (screening alanine transaminase or aspartate transaminase >3 times the upper limit of the normal range).
16. Active HIV infection or AIDS syndrome, or active hepatitis B or C virus infection
17. Active malignancy
18. Known active infection
19. C-reactive protein >20 mg/L

1. Necessità di dialisi
2. Sanguinamento attivo
3. Necessità di trasfusione di emazie e o storia recente di trasfusioni (entro 30 giorni prima dello screening)
4. Paziente attualmente in trattamento con Ferro Carbossimaltosio (ultima dose somministrata 60 giorni prima dello screening)
5. Paziente già incluso in un altro trial clinico sperimentale o in terapia già con un farmaco sperimentale entro I 30 giorni prima dello screening.
6. Pazienti non in grado di completare le visite richieste dallo studio
7. Pazienti di sesso femmine in fase fertile che non accettano di mantenere delle pratiche attive anticoncezionali durante lo studio e nei tre mesi successivi ad esso.
8. Pazienti incinte o in allattamento al momento delo screening
9. Pazienti noti per abuso di sostanze e disordini psichiatrici
10. Nota ipersensibilità al ferro solfato, al ferro carbossimaltosio, alla folina o ad altri eccipienti.
11. Evidenza di sovraccarico di ferro o altra patologia da accumulo marziale (emocromatosi, emolisi cronica)
12. Disordini del metabolismo del ferro (anemia sideroblastica e sideroacrestica, anemia saturnina, talassemia).
13. Anemia non attribuibile a carenza di ferro e malattia renale cronica, ad esempio altre forma di anemia microcitica
14. Pregressa evento avverso durante somministrazione di ferro
15. Pazienti con LES, artrite reumatoide, asma allegerica e patologie del fegato
16. Infezione attiva da HIV, HBV, HCV
17. Patologia oncologica attiva (meno di 5 anni dalla diagnosi o attualmente in terapia chemioterapica o radioterapica)
18. Infezione nota attiva
19. Proteina C Reattiva >20 mg/L

E.5 End points

E.5.1

Primary end point(s)

1. Average change in TSAT at 6 months in FCM treatment after non-responsive OIT

• la variazione media di TSAT nei pazienti trattati con ferro carbossimaltosio.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

1. Number of patients with TSAT >30% after 6 months of FCM treatment
2. Duration of administration of FCM and ESA to reach Hb levels >10.5 g/dL and <11.5 g/dL
3. Cumulative ESA dose in 12 weeks
4. Cumulative dose and frequency of administration of FCM in order to maintain Hb levels > 11.5 g/dL
5. Cumulative ESA dose in the FCM Treatment period
6. Cumulative dose of FCM in 12 weeks to reach Hb levels >10,5 g/dL and <11.5 g/dL
7. Need of blood transfusions
8. ESA hypo-responsiveness in FCM treatment
9. GFR slope

1. Il numero di pazienti con TSAT >30% dopo 6 mesi di terapia con FCM
2. Le dosi necessarie di FCM e ESA per raggiunge i livelli di emoglobina >10,5 g/dl <11,5 g/dl
3. La dose cumulativa di ESA a 12 settimane
4. La dose cumulativa e la frequenza di somministrazione di FCM per mantenere un Hb >11.5g/dl
5. La dose cumulativa di FCM a 12 settimane per raggiungere livelli di Hb >10,5 g/dl <11,5 g/dl
6. La necessità di trasfusioni di sangue
7. Il numero di casi di resistenza al trattamento con ESA durante somministrazione di FCM
8. Lo slope di GFR

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

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

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

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

pre post

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

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.8.6 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

LVLS

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)

Yes

F.1.3.1

Number of subjects for this age range:

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

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)

BEST CLINICAL PRACTICE

NORMALE PRATICA CLINICA

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

2021-01-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-05

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-05-04

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