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    Summary
    EudraCT Number:2015-001439-20
    Sponsor's Protocol Code Number:15HH2613
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-06
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-001439-20
    A.3Full title of the trial
    A Feasibility Randomised Controlled Trial: Effects of Oral Sodium Bicarbonate Supplementation in Patients on Haemodialysis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of oral sodium bicarbonate supplementation in haemodialysis patients
    A.3.2Name or abbreviated title of the trial where available
    Oral sodium bicarbonate supplementation in haemodialysis patients
    A.4.1Sponsor's protocol code number15HH2613
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImperial College Healthcare NHS Trust and Imperial College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNIHR Imperial Biomedical Research Centre
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College Heathcare NHS Trust
    B.5.2Functional name of contact pointDr Damien Ashby
    B.5.3 Address:
    B.5.3.1Street AddressDu Cane Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 0HS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02033135171
    B.5.5Fax number02033135169
    B.5.6E-maildamien.ashby@imperial.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Sodium Bicarbonate
    D.2.1.1.2Name of the Marketing Authorisation holderFocus Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSodium Bicarbonate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium bicarbonate
    D.3.9.1CAS number 144-55-8
    D.3.9.3Other descriptive namen/a
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    End stage renal disease and metabolic acidosis with renal replacement therapy of haemodialysis.
    E.1.1.1Medical condition in easily understood language
    Advanced kidney condition and its effects in the body due to build up of acid in the blood will be investigated in people having regular haemodialysis.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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).

    E.2.2Secondary objectives of the trial
    Secondary objectives:
    Investigate the effects of oral sodium bicarbonate supplementation on:

    1. Risk of arrhythmia (i.e. abnormal heart rhythm) as measured by Electrocardiogram (ECG) analysis.
    2. Muscle mass as measured by body composition monitoring.
    3. Muscle function as measured by handgrip strength test.
    4. Haemodialysis related cramps as measured by a symptom scale-renal questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients on haemodialysis for at least 3 months.
    2. Aged between 18-80 years old (male and female)
    3. Patients who primarily have predialysis bicarbonate levels of less than 22mmols/L (normal range is 22-26mmol/L) over the last 6 months.
    4. No active infections or cancer diagnosis.
    5. Able to give verbal and written informed consent.
    6. Patients who are not already taking oral sodium bicarbonate.
    E.4Principal exclusion criteria
    1.Patients who primarily have predialysis potassium levels of less than 4mmols over the last 6 months.
    2. Bedbound patients
    3. Patients with a dementia diagnosis
    4. Recurrent hospital admissions
    5. Patients taking lithium medication (as this can be less well absorbed in the presence of sodium bicarbonate).
    6. Non-English speaking and without access to a regular interpreter.
    7. Patients lacking capacity and therefore unable to provide written informed consent
    8. Pregnant patients
    9. Patients who are already taking oral sodium bicarbonate.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the predialysis blood potassium levels and intradialytic potassium gradient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The predialysis potassium levels will be measured throughout the study at weeks 1-8 and weeks 13-16.
    Total study duration is 16 weeks.
    E.5.2Secondary end point(s)
    1. Electrocardiogram analysis with measurement of QT interval dispersion.
    2. Body composition monitor to measure total body muscle mass.
    3. Handgrip strength to measure muscle strength.
    4. Symptom severity assessed with the use of a renal-scale symptom questionnaire to measure haemodialysis related cramps.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The electrocardiogram analysis will be done at baseline (week 4), middle of the study (weeks 8) and at the end of the study (week 16)
    2. The body composition monitor will be done at baseline (week 4) and end of the study (week 16).
    3. The handgrip strength test will be done at baseline (week 4) and end of the study (week 16).
    4. The renal-scale symptom questionnaire will be done at baseline (week 4), middle of the study (week 8) and end of the study (week 16).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard haemodialysis treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There will be no continued provision of the intervention (sodium bicarbonate capsules) to participants. Participants will return any unused medications at the end of the study and continue with their standard dialysis treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-03
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