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    Clinical Trial Results:
    CHARACTERIZATION OF RITUXIMAB PHARMACOKINETICS IN PATIENTS WITH KIDNEY DISEASES WITH PRIMARY GLOMERULAR AFFECTATION

    Summary
    EudraCT number
    		 2020-000484-23
    Trial protocol
    		 ES  
    Global end of trial date
    16 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2024
    First version publication date
    27 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NEFRTX1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vall d'Hebron Institute of Research
    Sponsor organisation address
    Paseo del Valle de Hebrón, 119-129 , Barcelona, Spain, 08035
    Public contact
    Maria Larrosa Garcia, Vall d'Hebron Institute of Research, 0034 934 89 30 00, maria.larrosa@vallhebron.cat
    Scientific contact
    Maria Larrosa Garcia, Vall d'Hebron Institute of Research, 0034 934 89 30 00, maria.larrosa@vallhebron.cat
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objetive of this study is to characterize the rituximab pharmacokinetic profile in patients with kidney disease with primary glomerular involvement; as well as evaluating the influence of proteinuria, FCGRT polymorphism and the presence of anti-drug antibodies on rituximab clearance.
    Protection of trial subjects
    Blood and urine sampling was minimized in order to reduce patients charge and disconfort.
    Background therapy
    		 This is a open-label, uncontrolled trial. All patients received rituximab according to clinical protocols and regular premedication including acetaminophen, methylprednisolone and dexchlorfeniramine, in order to avoid infusion reaction.
    Evidence for comparator
    		 This is an uncontrolled trial.
    Actual start date of recruitment
    07 Sep 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    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)
    21
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was done in the Vall d'Hebron University Hospital from September 2020 to May 2023.

    Pre-assignment
    Screening details
    		 Sixty-five patients went through screening, seventeen where not enrrolled due to refusal to participate in the clinical trial (16) and languaje barrier (1). Since patients received standard treatment in all cases in the context of an open-label, uncontrolled, low-intervention clinical trial there was not treatment assingment.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 RItuximab
    Arm description
    		 There was only one arm. All patients received rituximab according to clinical decision based on international clinical guidelines as a standard treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rituximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Patients received 500mg or 1000mg of rituximab according to clinical criteria, a second dose could be administered on day 14. Medication was prepared in the Hospital Pharmacy Service, following the good manufacturing practice (GMP) guidelines. Infusion was done accorging to standard clinical practice by trained nurses; measures to prevent infusion reaction included low rate infusion, post-infusion monitoring and premedication with acetaminophen, methylprednisolone and dexchlorfeniramine.

    Number of subjects in period 1
    		RItuximab
    Started
    48
    Pharmacokinetic analysis
    35
    Completed
    35
    Not completed
    13
         Samples degradation during conservation
    7
         Protocol deviation
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 48 48
    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
    Patients included were 62 (17) years old at the time at the enrollment. All of them were adults.
    Units: years
        arithmetic mean (standard deviation)
    		 62.3 ( 16.8 ) -
    Gender categorical
    Gender was obtained from the electronic medical record, where only male or female options are considered.
    Units: Subjects
        Female
    		 22 22
        Male
    		 26 26
    Diagnosis
    Patients could receive rituximab due to glomerular damage having differnet diseases.
    Units: Subjects
        ANCA-associated vasculitis
    		 16 16
        Membranous neprhopathy
    		 20 20
        Minimal change disease
    		 11 11
        Focal segmental glomerulosclerosis
    		 1 1
    Previous exposure to rituximab
    Patients that received rituximab previous to study enrollment. Rituximab was administered at least 6 months prioir to enrolment following inclusion criteria.
    Units: Subjects
        Previously exposed
    		 35 35
        Not previously exposed
    		 13 13
    Newly diagnosed
    Patients were considered newly diagnosed in case they received rituximab less than 3 months after diagnosis.
    Units: Subjects
        Yes
    		 7 7
        No
    		 41 41

    End points

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    End points reporting groups
    Reporting group title
    RItuximab
    Reporting group description
    		 There was only one arm. All patients received rituximab according to clinical decision based on international clinical guidelines as a standard treatment.

    Subject analysis set title
    Patients included
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients that received rituximab and have the minimum blood and urine samples available for analysis and pharmacokinetic evaluation.

    Subject analysis set title
    Patients enrolled
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients included.

    Primary: Maximum rituximab concentration

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    End point title
    		 Maximum rituximab concentration [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 after rituximab admisnitration.
    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: This is a low-intervention study to characterize rituximab pharmacokinetics in a population. The goal of this study was to describe pharmacokinetic parameters in this population; therefore, our results are descriptive and there is no statistical analysis of the endpoints.
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: µg/ml
        arithmetic mean (standard deviation)
    179.4 ( 71.8 )
    179.4 ( 71.8 )
    No statistical analyses for this end point

    Primary: Distribution volume

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    End point title
    		 Distribution volume [2]
    End point description
    End point type
    Primary
    End point timeframe
    This value was calculated at the time of pharmacockinetic analysis, when rituximab plasma concentrations measured from d1 to d45 were determined.
    Notes
    [2] - 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: This is a low-intervention study to characterize rituximab pharmacokinetics in a population. The goal of this study was to describe pharmacokinetic parameters in this population; therefore, our results are descriptive and there is no statistical analysis of the endpoints.
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: ml/kg
        arithmetic mean (standard deviation)
    78.9 ( 31.4 )
    78.9 ( 31.4 )
    No statistical analyses for this end point

    Primary: Clearance

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    End point title
    		 Clearance [3]
    End point description
    End point type
    Primary
    End point timeframe
    This value was calculated at the time of pharmacockinetic analysis, when rituximab plasma concentrations measured from d1 to d45 were determined.
    Notes
    [3] - 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: This is a low-intervention study to characterize rituximab pharmacokinetics in a population. The goal of this study was to describe pharmacokinetic parameters in this population; therefore, our results are descriptive and there is no statistical analysis of the endpoints.
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: ml/h/kg
        arithmetic mean (standard deviation)
    0.30 ( 0.27 )
    0.30 ( 0.27 )
    No statistical analyses for this end point

    Primary: Half-life

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    End point title
    		 Half-life [4]
    End point description
    End point type
    Primary
    End point timeframe
    This value was calculated at the time of pharmacockinetic analysis, when rituximab plasma concentrations measured from d1 to d45 were determined.
    Notes
    [4] - 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: This is a low-intervention study to characterize rituximab pharmacokinetics in a population. The goal of this study was to describe pharmacokinetic parameters in this population; therefore, our results are descriptive and there is no statistical analysis of the endpoints.
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: days
        arithmetic mean (standard deviation)
    11.6 ( 5.8 )
    11.6 ( 5.8 )
    No statistical analyses for this end point

    Primary: Elimination constant (Kel)

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    End point title
    		 Elimination constant (Kel) [5]
    End point description
    End point type
    Primary
    End point timeframe
    This value was calculated at the time of pharmacockinetic analysis, when rituximab plasma concentrations measured from d1 to d45 were determined.
    Notes
    [5] - 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: This is a low-intervention study to characterize rituximab pharmacokinetics in a population. The goal of this study was to describe pharmacokinetic parameters in this population; therefore, our results are descriptive and there is no statistical analysis of the endpoints.
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: h-1
        arithmetic mean (standard deviation)
    0.0036 ( 0.0030 )
    0.0036 ( 0.0030 )
    No statistical analyses for this end point

    Primary: Area under the curve

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    End point title
    		 Area under the curve [6]
    End point description
    End point type
    Primary
    End point timeframe
    This value was calculated at the time of pharmacockinetic analysis, when rituximab plasma concentrations measured from d1 to d45 were determined.
    Notes
    [6] - 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: This is a low-intervention study to characterize rituximab pharmacokinetics in a population. The goal of this study was to describe pharmacokinetic parameters in this population; therefore, our results are descriptive and there is no statistical analysis of the endpoints.
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: µg·h/ml
        arithmetic mean (standard deviation)
    117756.1 ( 88228.1 )
    117756.1 ( 88228.1 )
    No statistical analyses for this end point

    Secondary: Complete response

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    End point title
    		 Complete response
    End point description
    Complete response was evaluated according to Kidney Glomerular Diseases Guidelines 2021.
    End point type
    Secondary
    End point timeframe
    Clinical response was evaluated 1 year after rituximab administration (day 1).
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: patients
    14
    14
    No statistical analyses for this end point

    Secondary: Partial response

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    End point title
    		 Partial response
    End point description
    Complete response was evaluated according to Kidney Glomerular Diseases Guidelines 2021.
    End point type
    Secondary
    End point timeframe
    Clinical response was evaluated 1 year after rituximab administration (day 1).
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: patients
    12
    12
    No statistical analyses for this end point

    Secondary: Relapse

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    End point title
    		 Relapse
    End point description
    Relapse was evaluated according to Kidney Glomerular Diseases Guidelines 2021.
    End point type
    Secondary
    End point timeframe
    Clinical response was evaluated 1 year after rituximab administration (day 1).
    End point values
    		 RItuximab Patients included
    Number of subjects analysed
    35
    35
    Units: patients
    4
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded during the time of the study, one year after rituximab admisnitration.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Patients enrolled
    Reporting group description
    		 All the 48 patients enrolled were included in the safety analysis.

    Serious adverse events
    		 Patients enrolled
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Patients enrolled
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 48 (2.08%)
    Immune system disorders
    Infusion related hypersensitivity reaction
    Additional description: A patient experienced an infusion reaction with throat itching and redness of the ears. The adverse reaction was controlled with medication, and rituximab could continue to be administered minutes later at a slower rate under medical supervision.
         subjects affected / exposed
    1 / 48 (2.08%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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