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    Clinical Trial Results:
    The effect of low-dose salicylate treatment on platelet function in patients with renal failure treated with darbopoietin alfa (EPOASA study)

    Summary
    EudraCT number
    		 2018-002318-11
    Trial protocol
    		 DK  
    Global end of trial date
    31 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Aug 2026
    First version publication date
    22 Aug 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EPOASA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04330729
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The Danish Data Protection Agency: REG-018-2018
    Sponsors
    Sponsor organisation name
    Zealand University hospital
    Sponsor organisation address
    Vestermarksvej 10, Roskilde, Denmark, 4000
    Public contact
    Department of medicine, Zealand University hospital, james.heaf@gmail.com
    Scientific contact
    Department of medicine, Zealand University hospital, james.heaf@gmail.com
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    Sygehusvej 10, Roskilde, Denmark, 4000
    Public contact
    Rikke Borg, Zealand university hospital, department of medicin, 45 93569290, Rbor@regionsjaelland.dk
    Scientific contact
    Rikke Borg, Zealand University Hospital, 45 93569220, rbor@regionsjaelland.dk
    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
    05 Jan 2026
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effect of darbopoietin alfa on platelet function To determine whether Aspirin affects the effect of darbopoietin alfa on platelet function There is no randomization and no other endpoints than bloodsample results. Please see the attached table for full dataset (attached under platelets)
    Protection of trial subjects
    All blood tests were drawn concurrently with scheduled dialysis or outpatient check-ups to minimize the number of blood draws and hospital visits Patients experiencing gastrointestinal symptoms were offered concomitant treatment with pantoprazole. Hemoglobin levels were measured monthly, and EPO dosage was adjusted accordingly. If hemoglobin was below 6.8 at Visit 4, the planned pause in EPO therapy was deferred until hemoglobin reached at least 6.8.
    Background therapy
    		 The patients continued their usual medication, such as antihypertensives, phosphate binders, and diuretics.
    Evidence for comparator
    		 The patients served as their own controls. Blood samples were taken with and without EPO and low-dose aspirin, respectively.
    Actual start date of recruitment
    22 May 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
    Denmark: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    27
    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)
    15
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible individuals were identified using electronic medical records and were included upon written and orally informed consent.

    Pre-assignment
    Screening details
    		 Inclusion criteria: Age 18–85 years, CKD+ indication for ESA, and ability to provide informed consent. Exclusion criteria: Known allergy or contraindication to ASA, current clinical indication for ASA, reticulocyte count >99×10^9/L, current anticoagulant therapy Fifty-seven individuals were invited to participate in the study

    Period 1
    Period 1 title
    Visit2
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 All patients at visit 2 (after 4 weeks EPO wash out)
    Arm type
    		 All patients

    Investigational medicinal product name
    nothing
    Investigational medicinal product code
    Other name
    Nothing was administered at baseline (4 weeks wash out)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Unknown use
    Dosage and administration details
    As described, nothing was administered at baseline. However, I am required to specify a product.

    Number of subjects in period 1
    		All patients
    Started
    27
    ESA washout
    27
    Completed
    27
    Period 2
    Period 2 title
    Visit3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 All patients at visit 3
    Arm type
    		 All patients

    Investigational medicinal product name
    aranesp
    Investigational medicinal product code
    B03XA02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Darbepoetin alfa was administered intravenously in HD participants and subcutaneously in PD and non-dialysis CKD participants once weekly at a dose required to maintain a target hemoglobin level of approximately 6.5–7.2 mM.

    Number of subjects in period 2
    		All patients
    Started
    27
    ESA treatment alone
    23
    Completed
    23
    Not completed
    4
         Adverse event, serious fatal
    1
         Ceased ESA indication
    1
         Hemoglobin > 8mM
    1
         Recurrent infection
    1
    Period 3
    Period 3 title
    Visit4
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 All patients
    Arm type
    		 All patients

    Investigational medicinal product name
    aranesp
    Investigational medicinal product code
    B03XA02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Darbepoetin alfa was administered intravenously in HD participants and subcutaneously in PD and non-dialysis CKD participants once weekly at a dose required to maintain a target hemoglobin level of approximately 6.5–7.2 mM All patients: tablet Acetylsalicylic acid 75mg x 1 daily

    Investigational medicinal product name
    Acetylsalicylic acid
    Investigational medicinal product code
    B01AC06
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients: acetylsalicylic acid 75mg x 1daily

    Number of subjects in period 3
    		All patients
    Started
    23
    ESA+ASA treatment
    20
    Completed
    20
    Not completed
    3
         Ceased ESA indication
    1
         patient wish
    1
         Hemoglobin > 8mM
    1
    Period 4
    Period 4 title
    Visit5
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All patients
    Arm description
    		 All patients at visit 5
    Arm type
    		 All patients

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		All patients
    Started
    20
    Post-treatment washout
    15
    Completed
    15
    Not completed
    5
         patient wish
    3
         Hemoglobin <6,5mM
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Visit2
    Reporting group description
    		 -

    Reporting group values
    		 Visit2 Total
    Number of subjects
    		 27 27
    Age categorical
    Units: Subjects
    Age continuous
    All patients inkluded in the trial
    Units: years
        arithmetic mean (standard deviation)
    		 61 ( 15 ) -
    Gender categorical
    All patients included in the trial.
    Units: Subjects
        Female
    		 5 5
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients at visit 2 (after 4 weeks EPO wash out)
    Reporting group title
    All patients
    Reporting group description
    		 All patients at visit 3
    Reporting group title
    All patients
    Reporting group description
    		 All patients
    Reporting group title
    All patients
    Reporting group description
    		 All patients at visit 5

    Primary: Platelets

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    End point title
    		 Platelets
    End point description
    End point type
    Primary
    End point timeframe
    Visit 2, Visit 3, visit 4 and visit 5
    End point values
    		 All patients All patients All patients All patients
    Number of subjects analysed
    27
    23
    20
    15
    Units: x10^9/L
        arithmetic mean (standard deviation)
    236 ( 63 )
    254 ( 66 )
    248 ( 60 )
    225 ( 66 )
    Attachments
    		 Untitled (Filename: tables_EUdraCT.pdf)
    Statistical analysis title
    		 Differences between periods
    Statistical analysis description
    Statistical analyses were performed using Statistica version 12 (Tulsa, Arizona). Parametrically distributed variables were compared using Student's t-test; logarithmic transformation was applied where relevant. Non-parametric variables were compared using the Wilcoxon signed-rank test. Categorical data were analyzed using MANOVA or Chi-square tests. Correlation analyses were performed using Spearman’s rank correlation. A probability value <0.05 was considered statistically significant. If a par
    Comparison groups
    All patients v All patients v All patients v All patients
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Multiplate TRAP

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    End point title
    		 Multiplate TRAP
    End point description
    Comparing values between visits
    End point type
    Primary
    End point timeframe
    All visits
    End point values
    		 All patients All patients All patients All patients
    Number of subjects analysed
    27
    23
    20
    15
    Units: U
        arithmetic mean (standard deviation)
    137 ( 34 )
    131 ( 27 )
    120 ( 29 )
    124 ( 31 )
    Statistical analysis title
    		 Differences between periods
    Statistical analysis description
    Values compared between periods
    Comparison groups
    All patients v All patients v All patients v All patients
    Number of subjects included in analysis
    85
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 ≥ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Multiplate ADP

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    End point title
    		 Multiplate ADP [1]
    End point description
    End point type
    Primary
    End point timeframe
    All periods
    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 results in attached table.
    End point values
    		 All patients All patients All patients All patients
    Number of subjects analysed
    27
    23
    20
    15
    Units: unit(s)
        arithmetic mean (standard deviation)
    81 ( 26 )
    73 ( 24 )
    63 ( 21 )
    69 ( 21 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Every 4th week
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 All patients at visit 2 (after 4 weeks EPO wash out)

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 27 (22.22%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Cholangitis acute
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    shortness of breath
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    edema
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal cancer recurrent
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Declining kidney function
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    hip fracture
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 27 (77.78%)
    Cardiac disorders
    hypotension
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Bleeding gums
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 27 (37.04%)
         occurrences all number
    11
    increased tendency to fall
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Reflux gastritis
         subjects affected / exposed
    5 / 27 (18.52%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    shortness of breath
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Infections and infestations
    Infection
         subjects affected / exposed
    6 / 27 (22.22%)
         occurrences all number
    6

    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.
    Small sample size, surrogate laboratory markers of hemostasis rather than clinical events, short intervention periods, mino variations in dose and hemoglobin levels between visits.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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