Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A phase IV, randomized, double blind cross-over study to evaluate palatability of Patiromer compared to Sodium Polystyrene Sulfonate in healthy subjects

    Summary
    EudraCT number
    		 2019-004696-40
    Trial protocol
    		 FR  
    Global end of trial date
    03 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2021
    First version publication date
    18 Sep 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PAT-PAL-404
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vifor (International), Inc.
    Sponsor organisation address
    Rechenstrasse 37, St. Gallen,, Switzerland, 9014
    Public contact
    PAT-PAL-404 Clinical Study Team, Vifor (International), Inc., +41 588 518 000, PAT-PAL-404.study@viforpharma.com
    Scientific contact
    PAT-PAL-404 Clinical Study Team, Vifor (International), Inc., +41 588 518 000, PAT-PAL-404.study@viforpharma.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
    14 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: - Compare the overall acceptability of patiromer with sodium polystyrene sulfonate (SPS). Secondary Objectives: - Determine factors for non-positive acceptability (non-liking) - Determine the willingness for long-term use of patiromer and SPS
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki including amendments in force up to and including the time the study was conducted. The study was conducted in compliance with the International Council for Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP), Committee for Proprietary Medicinal Products Guideline (CPMP/ICH/135/95), compliant with the EU Clinical Trial Directive (Directive 2001/20/EC). Prior to initiation of the study, the protocol, the subject information sheet, and the Informed Consent Form (ICF) were reviewed and approved by an Independent Ethics Committee (IEC), CPP OUEST II – Angers, France, operating in accord with current regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 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
    France: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    55
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 From a total of 98 subjects screened 30 subjects were not included due to the following reasons: screen failrues (23 subjects); consent removal (5 subjects); supplementary subjects (2 subjects). A total of 68 of these subjects were included and randomised in the study. All subjects completed the study as per protocol.

    Period 1
    Period 1 title
    Overall trial (overall period)
    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
    		 Test-Reference
    Arm description
    		 Subjects assigned to treatment-sequence group T-R (T=test treatment and R=reference treatment) receiving Patiromer on Day 1 and Sodium Polystyrene Sulfonate on Day 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Patiromer
    Investigational medicinal product code
    Other name
    Veltassa®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of 8.4 g reconstituted with 80 ml of water before use and administrated latest 3 hours after breakfast. The administration was on D1 or D2 according to the randomisation.

    Investigational medicinal product name
    Sodium polystyrene sulfonate
    Investigational medicinal product code
    Other name
    Kayexalate®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of 15 g reconstituted with 80 ml of water before use and administrated latest 3 hours after breakfast. The administration was on D1 or D2 according to the randomisation.

    Arm title
    		 Reference-Test
    Arm description
    		 Subjects assigned to treatment-sequence group R-T ( R=reference treatment and T=test treatment) receiving Sodium Polystyrene Sulfonate on Day 1 and Patiromer on Day 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sodium Polystyrene Sulfonate
    Investigational medicinal product code
    Other name
    Kayexalate®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of 15 g reconstituted with 80 ml of water before use and administrated latest 3 hours after breakfast. The administration was on D1 or D2 according to the randomisation.

    Investigational medicinal product name
    Patiromer
    Investigational medicinal product code
    Other name
    Veltassa®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Single dose of 8.4 g reconstituted with 80 ml of water before use and administrated latest 3 hours after breakfast. The administration was on D1 or D2 according to the randomisation.

    Number of subjects in period 1
    		Test-Reference Reference-Test
    Started
    34
    34
    Completed
    34
    34

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Test-Reference
    Reporting group description
    		 Subjects assigned to treatment-sequence group T-R (T=test treatment and R=reference treatment) receiving Patiromer on Day 1 and Sodium Polystyrene Sulfonate on Day 2.

    Reporting group title
    Reference-Test
    Reporting group description
    		 Subjects assigned to treatment-sequence group R-T ( R=reference treatment and T=test treatment) receiving Sodium Polystyrene Sulfonate on Day 1 and Patiromer on Day 2.

    Reporting group values
    		 Test-Reference Reference-Test Total
    Number of subjects
    		 34 34 68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.7 ± 14.9 45.9 ± 15.6 -
    Gender categorical
    Units: Subjects
        Female
    		 19 18 37
        Male
    		 15 16 31
    Subject analysis sets

    Subject analysis set title
    Patiromer
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 68 subjects included in the study were randomised (Sequence T-R, N=34; Sequence R-T; N=34) and received both test and reference but alternatively. All 68 subjects were included in all analysis populations (intent-to-treat set (ITTS)/per-protocol set (PPS)/safety set (SS), N=68).

    Subject analysis set title
    Sodium polystyrene sulfonate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 68 subjects included in the study were randomised (Sequence T-R, N=34; Sequence R-T; N=34) and received both test and reference but alternatively. All 68 subjects were included in all analysis populations (intent-to-treat set (ITTS)/per-protocol set (PPS)/safety set (SS), N=68).

    Subject analysis sets values
    		 Patiromer Sodium polystyrene sulfonate
    Number of subjects
    68
    68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.8 ± 15.2
    46.8 ± 15.2
    Gender categorical
    Units: Subjects
        Female
    37
    37
        Male
    31
    31

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Test-Reference
    Reporting group description
    		 Subjects assigned to treatment-sequence group T-R (T=test treatment and R=reference treatment) receiving Patiromer on Day 1 and Sodium Polystyrene Sulfonate on Day 2.

    Reporting group title
    Reference-Test
    Reporting group description
    		 Subjects assigned to treatment-sequence group R-T ( R=reference treatment and T=test treatment) receiving Sodium Polystyrene Sulfonate on Day 1 and Patiromer on Day 2.

    Subject analysis set title
    Patiromer
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 68 subjects included in the study were randomised (Sequence T-R, N=34; Sequence R-T; N=34) and received both test and reference but alternatively. All 68 subjects were included in all analysis populations (intent-to-treat set (ITTS)/per-protocol set (PPS)/safety set (SS), N=68).

    Subject analysis set title
    Sodium polystyrene sulfonate
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All 68 subjects included in the study were randomised (Sequence T-R, N=34; Sequence R-T; N=34) and received both test and reference but alternatively. All 68 subjects were included in all analysis populations (intent-to-treat set (ITTS)/per-protocol set (PPS)/safety set (SS), N=68).

    Primary: Overall Acceptability Score

    		 Close Top of page
    End point title
    		 Overall Acceptability Score
    End point description
    LSM= Least squares means SPS= sodium polystyrene sulfonate A 9-point hedonic score (Palability questionnaire) was used to compare the overall acceptability of patiromer with SPS. The levels of rating ranged from 1 dislike extremely, 2 dislike very much, 3 dislike moderately, 4 dislike slightly, 5 neither like nor dislike, 6 like slightly, 7 like moderately, 8 like very much, to 9 like extremely. The overall acceptability score was analysed using a linear mixed model, including study treatment (test/reference, sequence, sex, age, BMI) and interaction terms as fixed effects (i.e., 15 variables). A selection of variables was performed by backward elimination.
    End point type
    Primary
    End point timeframe
    overall study period
    End point values
    		 Patiromer Sodium polystyrene sulfonate
    Number of subjects analysed
    68
    68
    Units: Hedonic Score
    least squares mean (standard error)
        LSM for each treatment group
    5.426 ± 0.206
    5.000 ± 0.206
    Statistical analysis title
    		 Overall acceptability - Patiromer
    Statistical analysis description
    Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS).
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0968 [1]
    Method
    		 Linear mixed model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.426
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.932
         upper limit
    		 0.0791
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.253
    Notes
    [1] - No significant difference between treatment groups was detected (p=0.0968).

    Secondary: Positive Acceptability (Liking)

    		 Close Top of page
    End point title
    		 Positive Acceptability (Liking)
    End point description
    Number of subjects with positive ratings for overall acceptability, mixing appearance, smell, taste, mouth feel/texture/consistency and aftertaste: Positive rating includes scores from 6 ("like slightly") to 9 ("like extremely").
    End point type
    Secondary
    End point timeframe
    overall study period
    End point values
    		 Patiromer Sodium polystyrene sulfonate
    Number of subjects analysed
    68
    68
    Units: Number of subjects
    number (not applicable)
        Overall acceptability - Yes
    32
    25
        Overall accetability - No
    36
    43
        Mixing - Yes
    30
    45
        Mixing - No
    38
    23
        Appearance - Yes
    38
    37
        Appearance - No
    30
    31
        Smell - Yes
    24
    40
        Smell - No
    44
    28
        Taste - Yes
    19
    22
        Taste - No
    49
    46
        Feel/texture/consistency - Yes
    17
    13
        Feel/texture/consistency - No
    51
    55
        Swallowing - Yes
    32
    20
        Swallowing - No
    36
    48
        Aftertaste - Yes
    22
    19
        Aftertaste - No
    46
    49
    Statistical analysis title
    		 LR positive overall acceptability
    Statistical analysis description
    LR = logistic regression Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS).Descriptive statistics showed that the proportion of subjects with positive ratings (rating ≥6) for the overall acceptability was higher in the patiromer group (47%) as compared to the SPS group (37%).
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1753 [2]
    Method
    		 Regression, Logistic
    Parameter type
    		 logistic regression
    Point estimate
    -0.4245
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.0385
         upper limit
    		 0.1894
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3132
    Notes
    [2] - The difference was not statistically significant (p=0.1753).

    Secondary: Non-Positive Acceptability (Non-Liking)

    		 Close Top of page
    End point title
    		 Non-Positive Acceptability (Non-Liking)
    End point description
    Number of subjects with negative ratings for overall acceptability was evaluated: negative rating includes scores from 4 (“dislike slightly”) to 1 (“dislike extremely”).
    End point type
    Secondary
    End point timeframe
    overall study period
    End point values
    		 Patiromer Sodium polystyrene sulfonate
    Number of subjects analysed
    68
    68
    Units: Number of subjects
    number (not applicable)
        Overall acceptability - Yes
    19
    32
        Overall acceptability - No
    49
    36
        Mixing - Yes
    24
    10
        Mixing - No
    44
    58
        Appearance - Yes
    18
    18
        Appearance - No
    50
    50
        Smell - Yes
    3
    7
        Smell - No
    65
    61
        Taste - Yes
    11
    27
        Taste - No
    57
    41
        Texture - Yes
    35
    47
        Texture - No
    33
    21
        Swallowing - Yes
    20
    28
        Swallowing - No
    48
    40
        Aftertaste - Yes
    16
    32
        Aftertaste - No
    52
    36
    Statistical analysis title
    		 LR non-positive overall acceptability
    Statistical analysis description
    LR = logistic regression Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS). Descriptive statistics showed that the proportion of subjects with negative ratings for overall acceptability was higher in the SPS group (47%) as compared to the patiromer group (28%).
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0195 [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 logistic regression
    Point estimate
    0.9286
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1495
         upper limit
    		 1.7077
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3975
    Notes
    [3] - A significant treatment effect was confirmed by logistic regression (p=0.0195).

    Secondary: Description of Acceptability Sub-scores

    		 Close Top of page
    End point title
    		 Description of Acceptability Sub-scores
    End point description
    Determination of factors of non-positive palatability rating based on the scores from 4 ("dislike slightly") to 1 ("dislike extremely). In case of non-liking of taste, texture, swallowing, aftertaste, the subjects were asked for the reasons of non-liking by offering pre-defined options to select from including free text description.
    End point type
    Secondary
    End point timeframe
    overall study period
    End point values
    		 Patiromer Sodium polystyrene sulfonate
    Number of subjects analysed
    68
    68
    Units: Number of subjects
    number (not applicable)
        Problem taste – Too salty
    0
    3
        Problem taste – Too bitter
    4
    5
        Problem taste – Too sour/acidic
    0
    2
        Problem taste – Too sweet
    0
    1
        Problem taste – Too astringent
    5
    12
        Problem taste – Other reasons
    2
    4
        Problem taste – No problem
    57
    41
        Problem texture – Too grainy/sandy
    24
    25
        Problem texture – Too sticky
    1
    1
        Problem texture – Too thick/heavy
    5
    8
        Problem texture – Too lingering
    4
    9
        Problem texture – Other reasons
    1
    4
        Problem texture - No problem
    33
    21
        Problem swallowing – Too thick/heavy
    3
    8
        Problem swallowing – Too fuzzy
    12
    8
        Problem swallowing – Too difficult/strenuous
    3
    8
        Problem swallowing – Other reasons
    2
    4
        Problem swallowing – No problem
    48
    40
        Problem aftertaste – Too grainy/sandy
    9
    11
        Problem aftertaste – Too sticky
    3
    3
        Problem aftertaste – Too lingering
    2
    4
        Problem aftertaste - No problem
    54
    50
    Statistical analysis title
    		 LMM on acceptability - Mixing
    Statistical analysis description
    LMM = Linear mixed model Linear mixed model on acceptability sub-score for mixing Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS).
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4926
         upper limit
    		 1.5368
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.261
    Notes
    [4] - A statistically significant difference between treatments in favour of SPS for the mixing sub-score (p=0.0002) was shown.
    Statistical analysis title
    		 LMM on acceptability - Feel/texture/consistency
    Statistical analysis description
    LMM = Linear mixed model Linear mixed model on acceptability sub-score for feel/texture/consistency Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS).
    Comparison groups
    Sodium polystyrene sulfonate v Patiromer
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0195 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.618
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1326
         upper limit
    		 -0.1027
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.258
    Notes
    [5] - A statistically significant difference between treatments in favour of patiromer for the feel/texture/consistency sub-score (p=0.0195) was shown.
    Statistical analysis title
    		 LMM on acceptability - Swallowing
    Statistical analysis description
    LMM = Linear mixed model Linear mixed model on acceptability sub-score for swallowing Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS).
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0048 [6]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.618
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.0401
         upper limit
    		 -0.1952
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.212
    Notes
    [6] - A statistically significant difference between treatments in favour of patiromer for the swallowing sub-score (p=0.0048) was shown.
    Statistical analysis title
    		 LMM on acceptability - Aftertaste
    Statistical analysis description
    LMM = Linear mixed model Linear mixed model on acceptability sub-score for aftertaste Subjects in this analysis n=136 refers to the sum of subjects treated with each treatment (N=68 for Patiromer; N=68 for SPS).
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0162 [7]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.676
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.224
         upper limit
    		 -0.1289
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.274
    Notes
    [7] - A statistically significant difference between treatments in favour of patiromer for the aftertaste sub-score (p=0.0162) was shown.

    Other pre-specified: Willingness for long term use

    		 Close Top of page
    End point title
    		 Willingness for long term use
    End point description
    Willingness to take the medicinal product every day for 3 months, 6 months, 12 months or longer than 12 months.
    End point type
    Other pre-specified
    End point timeframe
    overall study period
    End point values
    		 Patiromer Sodium polystyrene sulfonate
    Number of subjects analysed
    68
    68
    Units: Number of subjects
    number (not applicable)
        3 months
    34
    34
        6 months
    44
    24
        12 months
    43
    25
        Longer than 12 months
    44
    24
    Statistical analysis title
    		 6 months - Binomial Exact Test
    Statistical analysis description
    The willingness for long-term use of patiromer and SPS was analysed by descriptive statistics and a test of compatibility of data with a binomial (equal weight) distribution between patiromer and SPS.
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0205 [8]
    Method
    		 Binomial Exact Test
    Confidence interval
    Notes
    [8] - The subjects were statistically more willing to use patiromer versus SPS from 6 months onwards: 6 months (64.7% versus 35.3%, p-value=0.0205)
    Statistical analysis title
    		 12 months - Binomial Exact Test
    Statistical analysis description
    The willingness for long-term use of patiromer and SPS was analysed by descriptive statistics and a test of compatibility of data with a binomial (equal weight) distribution between patiromer and SPS.
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0385 [9]
    Method
    		 Binomial Exact Test
    Confidence interval
    Notes
    [9] - The subjects were statistically more willing to use patiromer versus SPS from 6 months onwards: 12 months (63.2% versus 36.8%, p-value=0.0385)
    Statistical analysis title
    		 More than 12 months - Binomial Exact Test
    Statistical analysis description
    The willingness for long-term use of patiromer and SPS was analysed by descriptive statistics and a test of compatibility of data with a binomial (equal weight) distribution between patiromer and SPS.
    Comparison groups
    Patiromer v Sodium polystyrene sulfonate
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0205 [10]
    Method
    		 Binomial Exact Test
    Confidence interval
    Notes
    [10] - The subjects were statistically more willing to use patiromer versus SPS from 6 months onwards: More than 12 months (64.7% versus 35.3, p-value=0.0205)

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    overall study period
    Adverse event reporting additional description
    All the TEAEs were of mild to moderate intensity. All the TEAEs were resolved before the end of the study. No SAEs were reported during this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Patiromer
    Reporting group description
    		 All 68 subjects included in the study were randomised (Sequence T-R, N=34; Sequence R-T; N=34) and received both test and reference but alternatively. All 68 subjects were included in all analysis populations (intent-to-treat set (ITTS)/per-protocol set (PPS)/safety set (SS), N=68).

    Reporting group title
    Sodium polystyrene sulfonate
    Reporting group description
    		 All 68 subjects included in the study were randomised (Sequence T-R, N=34; Sequence R-T; N=34) and received both test and reference but alternatively. All 68 subjects were included in all analysis populations (intent-to-treat set (ITTS)/per-protocol set (PPS)/safety set (SS), N=68).

    Serious adverse events
    		 Patiromer Sodium polystyrene sulfonate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 68 (0.00%)
    0 / 68 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Patiromer Sodium polystyrene sulfonate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 68 (8.82%)
    3 / 68 (4.41%)
    Nervous system disorders
    Dizziness postural
         subjects affected / exposed
    0 / 68 (0.00%)
    1 / 68 (1.47%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    3 / 68 (4.41%)
    2 / 68 (2.94%)
         occurrences all number
    3
    2
    Paraesthesia
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 68 (1.47%)
    0 / 68 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2020
    Implementation of health measures related to the COVID pandemic.

    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
    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.

    European Medicines Agency © 1995-Thu May 16 12:46:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA