Clinical Trials Register

Summary
EudraCT Number:	2014-003707-30
Sponsor's Protocol Code Number:	P140501
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-01-07
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

France - ANSM

A.2

EudraCT number

2014-003707-30

A.3

Full title of the trial

ETUDE PILOTE DE L'EFFET DU PRIVIGEN SUR DES PATIENTS TRANSPLANTES RENAUX A RISQUE DE PERTE DU GREFFON PAR REJET HUMORAL

A.3.1

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

Etude pilote de l'effet du Privigen sur des patients transplantés rénaux à risque de perte du greffon par rejet humoral

A.3.2

Name or abbreviated title of the trial where available

INAUGURAL

A.4.1

Sponsor's protocol code number

P140501

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	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
B.1.3.4	Country	France
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	Privigen 100 mg/ml, solution pour perfusion
D.2.1.1.2	Name of the Marketing Authorisation holder	CSL Behring GmbH, D-35041 Marburg, Allemagne
D.2.1.2	Country which granted the Marketing Authorisation	France
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	Privigen 100 mg/ml, solution pour perfusion
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Immunoglobuline humaine normale
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	100
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)	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	Yes
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

rejet humoral chronique d'un greffon rénal

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.1
E.1.2	Level	PT
E.1.2	Classification code	10038533
E.1.2	Term	Renal transplant
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

Déterminer si la progression vers le rejet humoral chronique pourrait être minimisée par l'administration post transplantation d'IgIV.

E.2.2

Secondary objectives of the trial

Evaluer l'effet du Privigen sur d'autres paramètres de rejet de greffe (protéinurie et histologie)
Le taux de sérum IVIg ainsi que l'effet du Privigen sur les évènements infectieux seront contrôlés

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patient ayant bénéficié d'une transplantation de rein de donneur décédé datant de 3 à 12 mois.
- Patient > = 18 ans
- Patient avec une fonction rénale stable évaluée dans les 30 jours précédant l'inclusion et un delta DFG inférieur à 10 ml/min (dernier résultat par rapport à la moyenne des deux valeurs précédentes et calculé d'après l'équation MDRD)
- Présence d'au moins un anticorps circulant HLA-DSA de classe I ou II contre les antigènes HLA-A, -B, C, -DR, -DQ, -DP (MFI > = 1000) évaluée par la technique Luminex antigène unique dans les 15 jours précédant l'inclusion.
- Avec marqueurs histologiques de lésions actives médiées par les anticorps telles que définies par le score de lésions inflammatoires de la microcirculation (scores g et ptc définis par les critères actuels de Banff) sur des biopsies effectuées à M3 et M12 post transplantation ou si nécessaire entre trois et douze mois suivant la transplantation (1 g+ ptc 3).
- Capable de respecter les procédures et de suivre les instructions de l'étude.
- Ayant lu la notice d'information et signé le formulaire de consentement éclairé.

E.4

Principal exclusion criteria

- Insuffisance rénale aiguë au moment de l'inclusion : diminution du DFG ou égal à 10 ml/min (dernier résultat par rapport à la moyenne des deux valeurs précédentes) ou augmentation de 20 % de la créatinine sérique.
- Antécédent d'épisode de rejet médié par les anticorps.
- Avec traitement antérieur par plasmaphérèse, IgIV, rituximab, eculizumab ou bortézomib dans les 12 mois précédent l'inclusion.
- Présence de lésions actives importantes médiées par les anticorps, comme défini par les critères de Banff, tel que g + ptc > 3 ou une glomérulopathie chronique de greffe (cg > 0).
- Antécédents d'insuffisance cardiaque (New York Heart Association [NYHA] III / IV), cardiomyopathie, troubles du rythme cardiaque cliniquement significatifs nécessitant un traitement, maladie cardiaque ischémique instable ou avancée, insuffisance cardiaque congestive ou hypertension sévère.
- Antécédents d'épisodes thrombotiques dans les 6 derniers mois (thrombose veineuse profonde, infarctus du myocarde, accident vasculaire cérébral).
- Allergie connue ou autres réactions sévères aux produits sanguins, y compris une intolérance aux précédentes IgIV (c.à.d. maux de tête violents, hypersensibilité, hémolyse intravasculaire).
- Taux d'IgA sériques avec un déficit complet.
- Hyperprolinémie connue.
- Infection VIH, hépatite C et hépatite B en cours.

E.5 End points

E.5.1

Primary end point(s)

Critère d'évaluation principal
Evolution de la fonction du greffon évaluée par le débit de filtration glomérulaire à M6 et M12.

Critères d'évaluation secondaires
-Mesure de la protéinurie à M6 et M12 comparé à M0.
-Dosage des anticorps HLA-DSA à M6 et M12 comparé à M0.
-Evolution histologique à M6 comparé à M0.
-Dosage des IgG à M0, avant chaque administration de Privigen®, M6
-Survenue d'évènements infectieux pendant l'étude.

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

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

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

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-01-07.	Yes
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	15

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

2014-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-17

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

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