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    Clinical Trial Results:
    A Feasibility Randomised Controlled Trial: Effects of Oral Sodium Bicarbonate Supplementation in Patients on Haemodialysis

    Summary
    EudraCT number
    		 2015-001439-20
    Trial protocol
    		 GB  
    Global end of trial date
    03 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2020
    First version publication date
    03 Jan 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    15HH2613
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02692378
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College Heathcare NHS Trust
    Sponsor organisation address
    Du Cane Road, London, United Kingdom, W12 0HS
    Public contact
    Dr Damien Ashby , Imperial College Heathcare NHS Trust , +44 02033135171, damien.ashby@nhs.net
    Scientific contact
    Dr Damien Ashby , Imperial College Heathcare NHS Trust , +44 02033135171, damien.ashby@nhs.net
    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
    03 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Principal research question: What are the effects of oral sodium bicarbonate supplementation in haemodialysis patients? Principal objective: Investigate the effect of oral sodium bicarbonate supplementation on blood potassium levels throughout the dialysis cycle (pre and post dialysis potassium and intradialysis potassium gradient).
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    28
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from three satellite haemodialysis units at Imperial NHS Trust between June 2015 and May 2016.

    Pre-assignment
    Screening details
    		 518 patients were screened and 130 were eligible for enrolment, finally enrolled 43 patients.

    Period 1
    Period 1 title
    Run-in phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sodium Bicarbonate
    Arm description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l), no treatment in run-in phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    no intervention
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Other use
    Dosage and administration details
    No intervention

    Number of subjects in period 1
    		Control Sodium Bicarbonate
    Started
    22
    21
    Completed
    19
    16
    Not completed
    3
    5
         Consent withdrawn by subject
    3
    5
    Period 2
    Period 2 title
    Treatment phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sodium Bicarbonate
    Arm description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l) with the addition of oral sodium bicarbonate 500mg capsules for 12 weeks (weeks 5-16 of the study). The dosage titrated to individual blood levels. Starting dose was 1g twice daily with the dose titrated during the first 4 weeks of treatment (increasing by 0.5g twice daily as tolerated, to a maximum of 3g bd) to achieve predialysis bicarbonate levels over 22mmols/L.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sodium bicarbonate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Starting dose 1g bd (4 tablets per day) with the dose titrated during the first 4 weeks of treatment (increasing by 0.5g bd as tolerated, to a maximum 3g bd) to achieve predialysis bicarbonate over 22mmol/l.

    Number of subjects in period 2
    		Control Sodium Bicarbonate
    Started
    19
    16
    Completed
    18
    15
    Not completed
    1
    1
         Renal transplant
    1
    1
    Period 3
    Period 3 title
    Wash out phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sodium Bicarbonate
    Arm description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l), no treatment just follow-up
    Arm type
    		 Active comparator

    Investigational medicinal product name
    no intervention
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Other use
    Dosage and administration details
    no intervention

    Number of subjects in period 3
    		Control Sodium Bicarbonate
    Started
    18
    15
    Completed
    18
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).

    Reporting group title
    Sodium Bicarbonate
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l), no treatment in run-in phase.

    Reporting group values
    		 Control Sodium Bicarbonate Total
    Number of subjects
    		 22 21 43
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 14 13 27
        From 65-84 years
    		 8 8 16
    Age continuous
    Units: years
        median (standard deviation)
    		 61 ( 9.7 ) 61 ( 14 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 10
        Male
    		 17 16 33
    Haemodialysis vintage
    The time participants have been on haemodialysis
    Units: months
        median (standard deviation)
    		 38 ( 46 ) 32 ( 48 ) -
    Subject analysis sets

    Subject analysis set title
    Non-bic Control
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Measurements over the first 4 weeks (run-in phase) and last 4 weeks (wash out phase) to establish blood potassium profile.

    Subject analysis set title
    Non-bic Sodium Bicarbonate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Measurements over the first 4 weeks (run-in phase) and last 4 weeks (wash out phase) to establish blood potassium profile.

    Subject analysis sets values
    		 Non-bic Control Non-bic Sodium Bicarbonate
    Number of subjects
    19
    15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    14
    13
        From 65-84 years
    4
    2
    Age continuous
    Units: years
        median (standard deviation)
    61 ( 9.7 )
    61 ( 14 )
    Gender categorical
    Units: Subjects
        Female
    4
    3
        Male
    15
    12
    Haemodialysis vintage
    The time participants have been on haemodialysis
    Units: months
        median (standard deviation)
    38 ( 46 )
    32 ( 48 )

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).

    Reporting group title
    Sodium Bicarbonate
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l), no treatment in run-in phase.
    Reporting group title
    Control
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).

    Reporting group title
    Sodium Bicarbonate
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l) with the addition of oral sodium bicarbonate 500mg capsules for 12 weeks (weeks 5-16 of the study). The dosage titrated to individual blood levels. Starting dose was 1g twice daily with the dose titrated during the first 4 weeks of treatment (increasing by 0.5g twice daily as tolerated, to a maximum of 3g bd) to achieve predialysis bicarbonate levels over 22mmols/L.
    Reporting group title
    Control
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).

    Reporting group title
    Sodium Bicarbonate
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l), no treatment just follow-up

    Subject analysis set title
    Non-bic Control
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Measurements over the first 4 weeks (run-in phase) and last 4 weeks (wash out phase) to establish blood potassium profile.

    Subject analysis set title
    Non-bic Sodium Bicarbonate
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Measurements over the first 4 weeks (run-in phase) and last 4 weeks (wash out phase) to establish blood potassium profile.

    Primary: Inter-dialytic Change in Dialysis Potassium Level (Pre and Post Dialysis Potassium Level)

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    End point title
    		 Inter-dialytic Change in Dialysis Potassium Level (Pre and Post Dialysis Potassium Level)
    End point description
    End point type
    Primary
    End point timeframe
    20 weeks
    End point values
    		 Control Sodium Bicarbonate Non-bic Control Non-bic Sodium Bicarbonate
    Number of subjects analysed
    19
    15
    19
    15
    Units: mmol/L
        geometric mean (standard deviation)
    2.00 ( 0.63 )
    1.69 ( 0.49 )
    2.08 ( 0.64 )
    1.9 ( 0.60 )
    Statistical analysis title
    		 Change in Dialysis Potassium - Sodium Bicarbonate
    Comparison groups
    Sodium Bicarbonate v Non-bic Sodium Bicarbonate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032
    Method
    		 paired t-test
    Confidence interval
    Statistical analysis title
    		 Change in Dialysis Potassium - Control
    Comparison groups
    Control v Non-bic Control
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.33
    Method
    		 paired t-test
    Confidence interval

    Secondary: Changes in QT dispersion, 12 lead Electrocardiogram analysis

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    End point title
    		 Changes in QT dispersion, 12 lead Electrocardiogram analysis
    End point description
    End point type
    Secondary
    End point timeframe
    20 weeks
    End point values
    		 Control Sodium Bicarbonate Non-bic Control Non-bic Sodium Bicarbonate
    Number of subjects analysed
    19
    15
    19
    15
    Units: ms
        geometric mean (standard deviation)
    8.8 ( 21.4 )
    10.4 ( 27.5 )
    8.7 ( 39.9 )
    8.8 ( 23 )
    Statistical analysis title
    		 Change in QT dispersion_control
    Statistical analysis description
    Control group
    Comparison groups
    Control v Non-bic Control
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 paired t-test
    Confidence interval
    Statistical analysis title
    		 Change in QT dispersion Sodium bicarbonate
    Comparison groups
    Sodium Bicarbonate v Non-bic Sodium Bicarbonate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.79
    Method
    		 paired t-test
    Confidence interval

    Secondary: Changes in Lean Tissue Mass

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    End point title
    		 Changes in Lean Tissue Mass
    End point description
    Body composition measurement before dialysis with the validated body composition monitor by Fresenius to measure lean tissue mass Analysis of lean tissue mass between the start and end of the treatment phase of the study
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Control Sodium Bicarbonate Control Sodium Bicarbonate
    Number of subjects analysed
    18
    15
    18
    15
    Units: percentage of lean mass
        arithmetic mean (standard deviation)
    51.8 ( 13.7 )
    45.0 ( 12.2 )
    50.2 ( 12.1 )
    45.5 ( 12.5 )
    Statistical analysis title
    		 Changes in Lean Tissue Mass_Sodium Bicarbonate
    Comparison groups
    Sodium Bicarbonate v Sodium Bicarbonate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.58
    Method
    		 paired t-test
    Confidence interval
    Statistical analysis title
    		 Changes in Lean Tissue Mass Control
    Comparison groups
    Control v Control
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.041
    Method
    		 paired t-test
    Confidence interval

    Secondary: Handgrip Strength

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    End point title
    		 Handgrip Strength
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Control Sodium Bicarbonate Control Sodium Bicarbonate
    Number of subjects analysed
    18
    15
    18
    15
    Units: kg
        arithmetic mean (full range (min-max))
    31.2 (14 to 51)
    26.6 (10 to 64)
    29.7 (14.3 to 51.8)
    26.2 (15.9 to 64.5)
    Statistical analysis title
    		 Handgrip Strength Sodium Bicarbonate
    Comparison groups
    Sodium Bicarbonate v Sodium Bicarbonate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.64
    Method
    		 paired t-test
    Confidence interval
    Statistical analysis title
    		 Handgrip Strength Control
    Comparison groups
    Control v Control
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 paired t-test
    Confidence interval

    Secondary: Changes in Total Symptom Severity

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    End point title
    		 Changes in Total Symptom Severity
    End point description
    End point type
    Secondary
    End point timeframe
    20 weeks
    End point values
    		 Control Sodium Bicarbonate Non-bic Control Non-bic Sodium Bicarbonate
    Number of subjects analysed
    19
    15
    18
    15
    Units: score on scale
        arithmetic mean (standard deviation)
    11.3 ( 7.4 )
    8.9 ( 6.6 )
    14.1 ( 9.6 )
    11.9 ( 9.2 )
    Statistical analysis title
    		 Total Symptom Severity Sodium Bicarbonate
    Comparison groups
    Sodium Bicarbonate v Non-bic Sodium Bicarbonate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1
    Method
    		 paired t-test
    Confidence interval
    Statistical analysis title
    		 Copy of Total Symptom Severity Control
    Comparison groups
    Control v Non-bic Control
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 paired t-test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly using a standard dialysate containing bicarbonate at a concentration of 35mmols/L(final dialysate bicarbonate 32mmol/l with acetate 3mmol/l).

    Reporting group title
    Sodium Bicarbonate
    Reporting group description
    		 Standard haemodialysis treatment thrice weekly, using a standard dialysate containing bicarbonate at a concentration of 35mmols/ (final dialysate bicarbonate 32mmol/l with acetate 3mmol/l), no treatment in run-in phase.

    Serious adverse events
    		 Control Sodium Bicarbonate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 22 (22.73%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Cerebral infarct
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain bleed
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectus sheath haematoma
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallstone pancreatitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Arthalgia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Sodium Bicarbonate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 22 (18.18%)
    4 / 21 (19.05%)
    Cardiac disorders
    High blood pressure
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Gastrointestinal bleeding
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Enterococcus faecalis infection
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Chest infection
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    3

    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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