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    Clinical Trial Results:
    CLINICAL PHARMACOKINETICS OF CASPOFUNGIN IN CRITICALLY ILL PATIENTS DURING CONTINUOUS VENO-VENOUS HEMOFILTRATION

    Summary
    EudraCT number
    		 2006-004106-87
    Trial protocol
    		 AT  
    Global end of trial date
    06 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Sep 2020
    First version publication date
    27 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAS CVVH
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Ao. Univ.Prof. Dr. Romuald Bellmann, Medical University Innsbruck, University Hospital for Internal Medicine I, +43 (0)512/ 504-23539, romuald.bellmann@tirol-kliniken.at
    Scientific contact
    Ao. Univ.Prof. Dr. Romuald Bellmann, Medical University Innsbruck, University Hospital for Internal Medicine I, +43 (0)512/ 504-23539, romuald.bellmann@tirol-kliniken.at
    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
    06 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to assess plasma pharmacokinetics in critically ill patients undergoing continuous veno-venous hemofiltration (CVVH), and to compare it with that of critically ill patients not requiring renal replacement therapy
    Protection of trial subjects
    No additional risks for the patients during the study. Drawing blood from an arterial line, which is needed for ICU routine monitoring, is without significant addidonal risk.
    Background therapy
    		 Subjects received treatment of an intensive care unit due to their medical history.
    Evidence for comparator
    		 There was no evidence for a comparator in this trial.
    Actual start date of recruitment
    23 Oct 2007
    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
    Austria: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We enrolled consecutive adult patients at a medical intensive care unit (ICU) with an indication for caspofungin.

    Pre-assignment
    Screening details
    		 We enrolled consecutive adult patients at a medical intensive care unit (ICU) with an indication for caspofungin.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CVVH patients
    Arm description
    		 Caspofungin pharmacokinetics during continuous renal replacement therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemofiltration (CVVH) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Two patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Five patients received only a single dose and for two subjects measurement was done on day 1 and at steady state.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cancidas
    Investigational medicinal product code
    Other name
    Caspofungin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to the manufacturer’s recommendation, the maintenance dose amounted to 50 mg per day in patients with a body weight of ≤ 80 kg and 70 mg once daily when body weight was > 80 kg. A loading dose of 70 mg was applied to all patients (infusion time, 1 h).

    Arm title
    		 CVVHD patients
    Arm description
    		 Caspofungin pharmacokinetics during continuous renal replacement therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemodialysis (CVVHD) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Four patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cancidas
    Investigational medicinal product code
    Other name
    Caspofungin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to the manufacturer’s recommendation, the maintenance dose amounted to 50 mg per day in patients with a body weight of ≤ 80 kg and 70 mg once daily when body weight was > 80 kg. A loading dose of 70 mg was applied to all patients (infusion time, 1 h).

    Arm title
    		 Control
    Arm description
    		 Caspofungin pharmacokinetics was assessed in 27 critically ill patients, including 13 patients not requiring continuous renal replacement therapy (CRRT). Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Twelve patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cancidas
    Investigational medicinal product code
    Other name
    Caspofungin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    According to the manufacturer’s recommendation, the maintenance dose amounted to 50 mg per day in patients with a body weight of ≤ 80 kg and 70 mg once daily when body weight was > 80 kg. A loading dose of 70 mg was applied to all patients (infusion time, 1 h).

    Number of subjects in period 1
    		CVVH patients CVVHD patients Control
    Started
    6
    8
    13
    Completed
    7
    7
    13
    Not completed
    0
    1
    0
         Transferred to other arm/group
    -
    1
    -
    Joined
    1
    0
    0
         Transferred in from other group/arm
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CVVH patients
    Reporting group description
    		 Caspofungin pharmacokinetics during continuous renal replacement therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemofiltration (CVVH) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Two patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Five patients received only a single dose and for two subjects measurement was done on day 1 and at steady state.

    Reporting group title
    CVVHD patients
    Reporting group description
    		 Caspofungin pharmacokinetics during continuous renal replacement therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemodialysis (CVVHD) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Four patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.

    Reporting group title
    Control
    Reporting group description
    		 Caspofungin pharmacokinetics was assessed in 27 critically ill patients, including 13 patients not requiring continuous renal replacement therapy (CRRT). Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Twelve patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.

    Reporting group values
    		 CVVH patients CVVHD patients Control Total
    Number of subjects
    		 7 8 13 28
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 5 7 9 21
        From 65-84 years
    		 2 1 4 7
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ( 7.87 ) 53.1 ( 12.54 ) 51.2 ( 18.09 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 2 6 12
        Male
    		 3 6 7 16

    End points

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    End points reporting groups
    Reporting group title
    CVVH patients
    Reporting group description
    		 Caspofungin pharmacokinetics during continuous renal replacement therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemofiltration (CVVH) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Two patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Five patients received only a single dose and for two subjects measurement was done on day 1 and at steady state.

    Reporting group title
    CVVHD patients
    Reporting group description
    		 Caspofungin pharmacokinetics during continuous renal replacement therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemodialysis (CVVHD) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Four patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.

    Reporting group title
    Control
    Reporting group description
    		 Caspofungin pharmacokinetics was assessed in 27 critically ill patients, including 13 patients not requiring continuous renal replacement therapy (CRRT). Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Twelve patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.

    Primary: Total caspofungin body clearence

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    End point title
    		 Total caspofungin body clearence [1]
    End point description
    Sampling was performed on day 1 of caspofungin treatment (single dose).
    End point type
    Primary
    End point timeframe
    Day 1
    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: The statistical significance of eventual differences in pharmacokinetic parameters between patients on and off CRRT was evaluated by the Mann-Whitney U test with Bonferroni’s correctionfor multiple testing. No statistical differences were found between the groups.
    End point values
    		 CVVH patients CVVHD patients Control
    Number of subjects analysed
    5
    4
    4
    Units: mL/ h/ kg
        arithmetic mean (standard deviation)
    7.92 ( 1.675 )
    9.95 ( 4.560 )
    10.8 ( 4.986 )
    No statistical analyses for this end point

    Primary: Total caspofungin body clearence

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    End point title
    		 Total caspofungin body clearence [2]
    End point description
    Sampling was performed at steady state on day 4 or later.
    End point type
    Primary
    End point timeframe
    Day 4- day 36
    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: The statistical significance of eventual differences in pharmacokinetic parameters between patients on and off CRRT was evaluated by the Mann-Whitney U test with Bonferroni’s correctionfor multiple testing. No statistical differences were found between the groups.
    End point values
    		 CVVH patients CVVHD patients Control
    Number of subjects analysed
    4
    7
    12
    Units: mL/ h/ kg
        arithmetic mean (standard deviation)
    6.53 ( 3.508 )
    4.01 ( 1.368 )
    6.24 ( 3.338 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1- day 36
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    CVVH patients
    Reporting group description
    		 Caspofungin pharmacokinetics during continuous renal replace-ment therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemofiltration (CVVH) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment(single dose) and at steady state on day 4 or later. Two patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Five patients received only a single dose and for two subjects measurement was done on day 1 and at steady state.

    Reporting group title
    CVVHD patients
    Reporting group description
    		 Caspofungin pharmacokinetics during continuous renal replace-ment therapy (CRRT), however, has been unknown so far. Therefore, we investigated the influence of continuous venovenous hemodialysis (CVVHD) on the pharmacokinetics of caspofungin in critically ill patients in order to assess the appropriateness of standard dosage during CRRT. Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Four patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.

    Reporting group title
    Control
    Reporting group description
    		 Caspofungin pharmacokinetics was assessed in 27 critically ill patients, including 13 patients not requiring continuous renal replacement therapy (CRRT). Sampling was performed on day 1 of caspofungin treatment (single dose) and at steady state on day 4 or later. Twelve patients were already on caspofungin when admitted to the ICU, and thus, sampling after the first dose was missed. Four patients received only a single dose and for three subjects measurement was done on day 1 and at steady state.

    Serious adverse events
    		 CVVH patients CVVHD patients Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CVVH patients CVVHD patients Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AEs were observed in this trial.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Apr 2010
    Caspofungin in plasma and ultrafiltrate samples will be quantified by LCMS/MS at the Central Institute for Medical and Chemical Laboratory Diagnostics (ZIMCL). The instrumental setup is identical to equipment used for the routine immunosuppressant TDM of the ZIMCL (Seger et al. 2009). Briefly, a sample aliquot is pre-treated (protein precipitation) prior to transfer to the LC system. A online SPE purification is preceding the chromatographic separation on a RP-C18 column. The tandem MS (MS/MS) based analyte detection is performed in the selected reaction mode. Analyte quantification is relying on the added internal standard and on external calibration with Caspofungin. The method is linear in the range from 200 – 15000 ng/ml and a inter-day CV of <10 can be achieved.
    15 Jul 2010
    The aim of this research project is to determine caspofungin pharmacokinetics in critically ill patients requiring continuous veno-venous hemofiltration (CVVH) and continuous veno-venous hemodialysis (CVVHD) and to provide dose recommendation for these groups of patients. 10 patients undergoing CVVHD will be enrolled.
    18 Aug 2011
    To assess the effect of CVVH on caspofungin pharmacokinetics, 15 patients undergoing CVVH, 15 patients undergoing CVVHD will be enrolled. Another 15 patients on caspofungin therapy, who are not treated with CVVH, are included as a control group. Patient enrolment is estimated to be completed at the end of 2013 (31.12.2013).

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23733471
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