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    Clinical Trial Results:
    Prospective, randomized, multi-center, double-blind, controlled, two-period, two-treatment, crossover, phase II trial to evaluate the safety and efficacy of PD-protec® in peritoneal dialysis in patients with chronic renal failure

    Summary
    EudraCT number
    		 2013-000400-42
    Trial protocol
    		 AT  
    Global end of trial date
    10 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2021
    First version publication date
    17 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ZP_PDProtec-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zytoprotec GmbH
    Sponsor organisation address
    Mariannengasse 28/2, Vienna, Austria, 1090
    Public contact
    Bernd Seibel, Zytoprotec GmbH, 0043 14062002, office@zytoprotec.com
    Scientific contact
    Bernd Seibel, Zytoprotec GmbH, 0043 14062002, office@zytoprotec.com
    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
    10 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to examine if PD-protec provides benefits for peritoneal health by measuring cancer antigen 125 (CA-125) appearance rate and ex vivo stimulated interleukin (IL)-6 release in 1 hour PD effluent.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2014
    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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    33
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in: 26-Jun-2014 Last patient out: 10-Nov-2016 Recruitment Duration: 24 months Countries: Austria Number of centers: 8

    Pre-assignment
    Screening details
    		 Screening tests have been conducted within 35 days prior to the beginning of the treatment I period.

    Period 1
    Period 1 title
    Run-in
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A-B
    Arm description
    		 Screening Tests have been conducted within 35 days prior to the beginning of Treatment Period I.
    Arm type
    		 Sequence A-B

    Investigational medicinal product name
    Physioneal 40
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for peritoneal dialysis
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    A: Physioneal 40 Glucose 1.36%, 2.27% and 3.86% (as DCB). Dose: volume of PDF will vary with patient’s body weight and based on patient’s pre-randomization PD prescription by physician

    Arm title
    		 Sequence B-A
    Arm description
    		 Screening Tests have been conducted within 35 days prior to the beginning of Treatment Period I.
    Arm type
    		 Sequence B-A

    Investigational medicinal product name
    Physioneal 40 with added Placebo (Aqua bidest)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for peritoneal dialysis
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    A: Physioneal 40 Glucose 1.36%, 2.27% and 3.86% (as DCB). Dose: volume of PDF will vary with patient’s body weight and based on patient’s pre-randomization PD prescription by physician

    Number of subjects in period 1
    		Sequence A-B Sequence B-A
    Started
    25
    25
    Completed
    24
    23
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    -
    1
    Period 2
    Period 2 title
    Treatment period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment period 1 Sequence A-B
    Arm description
    		 Physioneal 40 with added Placebo (Aqua bidest)
    Arm type
    		 Sequence A-B

    Investigational medicinal product name
    Physioneal 40 with added Placebo (Aqua bidest)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for peritoneal dialysis
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    A: Physioneal 40 Glucose 1.36%, 2.27% and 3.86% (as DCB) with an added placebo (Aqua bidest®: water for injection) Dose: volume of PDF will vary with patient’s body weight and based on patient’s pre-randomization PD prescription by physician

    Arm title
    		 Treatment period 1 Sequence B-A
    Arm description
    		 Sequence A-B: Physioneal40 (Reference Product) - PD-protec (IMP)
    Arm type
    		 Sequence B-A

    Investigational medicinal product name
    PD-protec DCB 8.0
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for peritoneal dialysis
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Dipeptiven (N(2)-Alanyl-L-Glutamine 200 mg/mL) added to Physioneal 40 Glucose 1.36%, 2.27% and 3.86% to a final concentration of 8 mM (1.74 g/L). Dose: amount of AGD per liter PDF is constant (8 mM); volume of PDF will vary with patient’s body weight and individual PD prescription by physician.

    Number of subjects in period 2
    		Treatment period 1 Sequence A-B Treatment period 1 Sequence B-A
    Started
    24
    23
    Completed
    20
    21
    Not completed
    4
    2
         Adverse event, non-fatal
    2
    2
         Transplantation
    2
    -
    Period 3
    Period 3 title
    Treatment period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment period 2 Sequence A-B
    Arm description
    		 Sequence A-B: Physioneal40 (Reference Product) - PD-protec (IMP)
    Arm type
    		 Sequence A-B

    Investigational medicinal product name
    PD-protec DCB 8.0
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for peritoneal dialysis
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    Dipeptiven (N(2)-Alanyl-L-Glutamine 200 mg/mL) added to Physioneal 40 Glucose 1.36%, 2.27% and 3.86% to a final concentration of 8 mM (1.74 g/L). Dose: amount of AGD per liter PDF is constant (8 mM); volume of PDF will vary with patient’s body weight and individual PD prescription by physician.

    Arm title
    		 Treatment period 2 Sequence B-A
    Arm description
    		 Physioneal 40 with added Placebo (Aqua bidest)
    Arm type
    		 Sequence B-A

    Investigational medicinal product name
    Physioneal 40 with added Placebo (Aqua bidest)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for peritoneal dialysis
    Routes of administration
    Intraperitoneal use
    Dosage and administration details
    A: Physioneal 40 Glucose 1.36%, 2.27% and 3.86% (as DCB) with an added placebo (Aqua bidest®: water for injection) Dose: volume of PDF will vary with patient’s body weight and based on patient’s pre-randomization PD prescription by physician

    Number of subjects in period 3
    		Treatment period 2 Sequence A-B Treatment period 2 Sequence B-A
    Started
    20
    21
    Completed
    19
    18
    Not completed
    1
    3
         Adverse event, non-fatal
    1
    2
         Transplantation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence A-B
    Reporting group description
    		 Screening Tests have been conducted within 35 days prior to the beginning of Treatment Period I.

    Reporting group title
    Sequence B-A
    Reporting group description
    		 Screening Tests have been conducted within 35 days prior to the beginning of Treatment Period I.

    Reporting group values
    		 Sequence A-B Sequence B-A Total
    Number of subjects
    		 25 25 50
    Age categorical
    Age was categorized as <65 years and ≥65 years.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 16 17 33
        From 65-84 years
    		 9 8 17
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 10 17
        Male
    		 18 15 33

    End points

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    End points reporting groups
    Reporting group title
    Sequence A-B
    Reporting group description
    		 Screening Tests have been conducted within 35 days prior to the beginning of Treatment Period I.

    Reporting group title
    Sequence B-A
    Reporting group description
    		 Screening Tests have been conducted within 35 days prior to the beginning of Treatment Period I.
    Reporting group title
    Treatment period 1 Sequence A-B
    Reporting group description
    		 Physioneal 40 with added Placebo (Aqua bidest)

    Reporting group title
    Treatment period 1 Sequence B-A
    Reporting group description
    		 Sequence A-B: Physioneal40 (Reference Product) - PD-protec (IMP)
    Reporting group title
    Treatment period 2 Sequence A-B
    Reporting group description
    		 Sequence A-B: Physioneal40 (Reference Product) - PD-protec (IMP)

    Reporting group title
    Treatment period 2 Sequence B-A
    Reporting group description
    		 Physioneal 40 with added Placebo (Aqua bidest)

    Subject analysis set title
    Physioneal
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    CA-125: concentration at 4-hour PDE; volume alone: concentration (4-hour) – concentration(0-hour); and (concentration (4-hour) – concentration (0-hour))*volume / time • IL-6 release: IL-6 release at 1-hour PDE / basal IL-6 release at 4-hour PDE

    Subject analysis set title
    PD-Protec
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    CA-125: concentration at 4-hour PDE; volume alone: concentration (4-hour) – concentration(0-hour); and (concentration (4-hour) – concentration (0-hour))*volume / time • IL-6 release: IL-6 release at 1-hour PDE / basal IL-6 release at 4-hour PDE

    Primary: CA-125 apperance rate (U/min), FAS

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    End point title
    		 CA-125 apperance rate (U/min), FAS
    End point description
    End point type
    Primary
    End point timeframe
    CA-125: concentration at 4-hour PDE; volume alone: concentration (4-hour) – concentration(0-hour); and (concentration (4-hour) – concentration (0-hour))*volume / time • IL-6 release: IL-6 release at 1-hour PDE / basal IL-6 release at 4-hour PDE
    End point values
    		 Physioneal PD-Protec
    Number of subjects analysed
    41
    41
    Units: U/min
        median (standard deviation)
    253.9 ± 103.1
    302.3 ± 141.7
    Statistical analysis title
    		 Primary
    Statistical analysis description
    The sample size calculation was based on the effect on the CA-125 concentration using data from the previous first-in-man trial.18 Sample sizes between 32 and 36 patients would result in power values between 89% and 92% assuming a difference in means of 7 units and a crossover analysis of variance root mean square error of 8.5 using a 1-sided 2-group t-test. An effect of 7 units in concen- tration would translate to mean difference of approximately 58 U/min in the CA-125 appearance rate.
    Comparison groups
    Physioneal v PD-Protec
    Number of subjects included in analysis
    82
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Log-transformed
    Confidence interval

    Primary: stimulated IL-6 release (1 h) ([log10] pg/ml), FAS

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    End point title
    		 stimulated IL-6 release (1 h) ([log10] pg/ml), FAS
    End point description
    End point type
    Primary
    End point timeframe
    CA-125: concentration at 4-hour PDE; volume alone: concentration (4-hour) – concentration(0-hour); and (concentration (4-hour) – concentration (0-hour))*volume / time • IL-6 release: IL-6 release at 1-hour PDE / basal IL-6 release at 4-hour PDE
    End point values
    		 Physioneal PD-Protec
    Number of subjects analysed
    41
    41
    Units: pg/ml
        arithmetic mean (standard deviation)
    1.36 ± 0.55
    1.52 ± 0.48
    Statistical analysis title
    		 Primary
    Statistical analysis description
    The sample size calculation was based on the effect on the CA-125 concentration using data from the previous first-in-man trial.18 Sample sizes between 32 and 36 patients would result in power values between 89% and 92% assuming a difference in means of 7 units and a crossover analysis of variance root mean square error of 8.5 using a 1-sided 2-group t-test. An effect of 7 units in concentration would translate to mean difference of approximately 58 U/min in the CA-125 appearance rate.
    Comparison groups
    Physioneal v PD-Protec
    Number of subjects included in analysis
    82
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Log-transformed
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From signing of the informed consent until the end of the study (end of study visit).
    Adverse event reporting additional description
    Safety population: All patients treated at least once with the study medication. All patients were analyzed according to the treatment they received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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 serious AE was related to the study treatment, less than 5% of the non serious AEs were assessed as at least possibly related to study treatment

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2014
    Version 1.2 In addition to a number of minor changes, relevant changes included: • Change in inclusion criteria no. 4 (“Extraneal allowed; Nutrineal not allowed” was deleted) and no. 5 (text was added “in CAPD patients or, in the case of APD, during nightly cycler treatment [additional exchange with Extraneal allowed; Nutrineal not allowed]) • Clarifications with respect to the following were added: i) IMP handling manual will be provided to patients: ii) up to 3-month data for some PD parameters will be acceptable to be documented at baseline, III) performance of PET procedure at Visit 1
    24 Jun 2014
    Version 1.3 The following changes were implemented in the protocol: • Study medication (IMP and reference product) was to be mixed by a study nurse at patient’s home within 72 hours prior to drug administration. • In case of an infection, the PET could be delayed for additional 7 days.
    06 Mar 2015
    Version 1.4 Study will not be conducted in Hungary, as initially planned, but only in Austria. This resulted in a number of changes in the protocol, including: • Total number of centers and patients to be enrolled were reduced • One stratification factor (SCB) was excluded • Re-estimation of sample size • Implementation of a complementary randomization schedule and additional emergency envelops with additional 48 randomization numbers stratified by peritonitis status
    05 Nov 2015
    Version 1.5 In addition to few minor changes, relevant changes included: • Change in inclusion criteria no. 5 (text added is shown in bold“…in CAPD patients or, in the case of APD, during nightly cycler treatment on at least 5 out of 7 days per week [additional exchange with Extraneal allowed; Nutrineal not allowed]) • Randomization was to performed after screening, and not at baseline (Visit 1)
    08 Apr 2016
    Version 1.6 Major changes in the study design were implemented with this protocol amendment. Relevant changes included: • Change in study title (“adaptive design” was excluded from the title) • Re-estimation of sample size and study power • Cancelation of interim analysis and related changes in the primary analysis • Cancelation of data monitoring committee involvement • Modification of the stratification by previous peritonitis (yes/no), aiming for 1:1 ratio if a sufficient number of patients with positive peritonitis could be enrolled

    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/30360960
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