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Clinical Trial Results:
Efficacité du Rituximab au cours du syndrome néphrotique idiopathique ciclosporinodépendant de l'enfant.

Summary
EudraCT number	2009-018266-35
Trial protocol	FR BE
Global end of trial date	23 Jun 2014

Results information
Results version number	v1(current)
This version publication date	03 Jun 2021
First version publication date	03 Jun 2021
Other versions
Summary report(s)	RRF Nephrutix Statistical report

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I08013

ISRCTN number

US NCT number

NCT01268033

WHO universal trial number (UTN)

Sponsor organisation name

CHU de Limoges

Sponsor organisation address

2 avenue Martin Luther King, Limoges, France,

Public contact

Pr Vincent GUIGONIS, CHU de Limoges, +33 55556358, vincent.guigonis@unilim.fr

Scientific contact

Pr Vincent GUIGONIS, CHU de Limoges, +33 55556358, vincent.guigonis@unilim.fr

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

19 Aug 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

23 Jun 2014

Global end of trial reached?

Yes

Global end of trial date

23 Jun 2014

Was the trial ended prematurely?

Main objective of the trial

Evaluer l’efficacité, en terme de prévention des rechutes lors d’une stratégie d’épargne des autres traitements immunosuppresseurs, du Rituximab dans le traitement des patients présentant un syndrome néphrotique ciclosporinodépendant, dans la population en intention de traiter.

Protection of trial subjects

Premedication administered to patients should be completed 30 minutes before the infusion: For patients weighing less than 40 kg: - Paracetamol 20mg / kg (maximum 1g per infusion). - Antihistamine: intravenous or oral: * Dexchlorpheniramine: 1 ampoule of 5 mg IV (if weight greater than 20 kg) and ½ bulb if weight less than 20 kg). *Or Citerizine (oral route): <6 years: 2.5 mg; <12 years: 5 mg; ≥12 years: 10mg. - Methylprednisolone: 0.5 mg / kg (maximum 20 mg IV). For patients weighing 40 kg and over: - Paracetamol (1g IV). - Antihistamine: intravenous or oral: *Dexchlorpheniramine: 1 ampoule of 5 mg IV. *Or Citerizine (oral route): 10mg. - Methylprednisolone: 100mg IV.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Mar 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 26

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

No pre-assignment period

Period 1 title

overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Arm type

Placebo

Investigational medicinal product name

Glucose 5%

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous drip use

Dosage and administration details

in a bag of 250 ml for intravenous drip use

Investigational medicinal product name

Sodium chloride 0.9%

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous drip use

Dosage and administration details

use only for diabetic patient in a bag of 250 ml for intravenous drip use

Mabthera

Arm description

Arm type

Experimental

Investigational medicinal product name

Rituximab 100mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous drip use

Dosage and administration details

750 mg/m² per day diluted in a bag of 250 ml for intravenous drip use 375mg/m² maximum per pefusion

Investigational medicinal product name

Rituximab 500mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous drip use

Dosage and administration details

750 mg/m² per day diluted in a bag of 250 ml for intravenous drip use 375mg/m² maximum per pefusion

Number of subjects in period 1	Placebo	Mabthera
Started	14	12
Completed	13	12
Not completed	1	0
lack of inclusion criteria	1	-

Baseline characteristics

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Reporting group title

overall study

Reporting group description

Reporting group values	overall study	Total
Number of subjects	26	26
Age categorical
Units: Subjects
In utero		0
Preterm newborn infants (gestational age < 37 wks)		0
Newborns (0-27 days)		0
Infants and toddlers (28 days-23 months)		0
Children (2-11 years)		0
Adolescents (12-17 years)		0
Adults (18-64 years)		0
From 65-84 years		0
85 years and over		0
Age continuous
Units: years
median (full range (min-max))	12 (5.34 to 17.34)	-
Gender categorical
Units: Subjects
Female	7	7
Male	19	19

Subject analysis set title

Treated patients

Subject analysis set type

Intention-to-treat

Subject analysis set description

all patient treated

Subject analysis sets values	Treated patients
Number of subjects	25
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age continuous
Units: years
median (full range (min-max))	12,16 (5.34 to 17.34)
Gender categorical
Units: Subjects
Female	6
Male	19

End points

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Reporting group title

Placebo

Reporting group description

Reporting group title

Mabthera

Reporting group description

Subject analysis set title

Treated patients

Subject analysis set type

Intention-to-treat

Subject analysis set description

all patient treated

Primary: Number of patients having relapsed within 5 months

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End point title

Number of patients having relapsed within 5 months ^[1]

End point description

End point type

Primary

End point timeframe

5 months

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: see statistical report

End point values	Placebo	Mabthera
Number of subjects analysed	13	12
Units: number	13	2

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

overall study

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

All patients

Reporting group description

Serious adverse events	All patients
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 25 (20.00%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0
Nervous system disorders
Venous thrombosis
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Drug ineffective for unapproved indication
subjects affected / exposed	2 / 25 (8.00%)
occurrences causally related to treatment / all	0 / 2
deaths causally related to treatment / all	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Gastrointestinal pain
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vomiting
subjects affected / exposed	2 / 25 (8.00%)
occurrences causally related to treatment / all	0 / 3
deaths causally related to treatment / all	0 / 0
gastrointestinal trouble
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
eating intolerance
subjects affected / exposed	1 / 25 (4.00%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	All patients
Total subjects affected by non serious adverse events
subjects affected / exposed	18 / 25 (72.00%)
Nervous system disorders
Headache
subjects affected / exposed	9 / 25 (36.00%)
occurrences all number	14
Gastrointestinal disorders
Gastrointestinal pain
subjects affected / exposed	9 / 25 (36.00%)
occurrences all number	9
Vomiting
subjects affected / exposed	4 / 25 (16.00%)
occurrences all number	8
Infections and infestations
nasopharyngitis
subjects affected / exposed	10 / 25 (40.00%)
occurrences all number	15

More information

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Were there any global substantial amendments to the protocol? Yes

15 Dec 2010

Addition of the PedsQL quality of life scale.

10 Feb 2011

Decrease in the period of use of anticalcineurins from 3 years to 1 year

21 Mar 2012

Clarification on the treatment methods in the event of a relapse. Addition of an investigation center. Update of the remedication modalities.

21 Mar 2013

Extension of the inclusion period by one year. Addition of investigator. Provision of details concerning the methods of decreasing immunosuppressive treatments Update of the side effects of Rituximab in the information leaflet following the letter of modifications from the ROCHE laboratory.

12 Jul 2013

Increased number of subjects required

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/29056249

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Clinical trials

Clinical Trial Results:
Efficacité du Rituximab au cours du syndrome néphrotique idiopathique ciclosporinodépendant de l'enfant.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of patients having relapsed within 5 months

Primary: Number of patients having relapsed within 5 months

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

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Clinical trials

Clinical Trial Results: Efficacité du Rituximab au cours du syndrome néphrotique idiopathique ciclosporinodépendant de l'enfant.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of patients having relapsed within 5 months

Primary: Number of patients having relapsed within 5 months

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Efficacité du Rituximab au cours du syndrome néphrotique idiopathique ciclosporinodépendant de l'enfant.