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    Summary
    EudraCT Number:2013-002037-38
    Sponsor's Protocol Code Number:NL44415.078.13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-30
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002037-38
    A.3Full title of the trial
    The effect of correction of metabolic acidosis in chronics kidney disease on intrarenal RAS activity.
    Het effect van het corrigeren van metabole acidose bij chronische
    nierinsufficientie op de activiteit van het intrarenale RAS.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does correction of acidity decrease kidney damage?
    Vermindert correctie van de zuurgraad nierschade?
    A.3.2Name or abbreviated title of the trial where available
    BIC study
    BIC studie
    A.4.1Sponsor's protocol code numberNL44415.078.13
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 No
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 chloride
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metabolic acidosis in chronic kidney disease
    Metabole acidose bij chronische nierinsufficientie
    E.1.1.1Medical condition in easily understood language
    High blood acidity in patients with chronic kidney disease
    verhoogde zuurgraad van het bloed bij mensen met een chronische
    nierziekte
    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
    To study if sodiumbicarbonate therapy diminishes activity of the
    intrarenal renin-angiotensin-system (RAS) without affecting the
    systemic RAS, i.e. the intrarenal RAS can be inhibited by oral alkali in
    CKD patients with metabolic acidosis.
    Om te bestuderen of natriumbicarbonaat de activiteit van het intrarenale
    renine-angiotensine-systeem vermindert, zonder het systemische RAS te
    beinvloeden. In andere woorden: het intrarenale RAS kan worden
    geremd door orale alkali in patienten met chronische nierschade en
    metabole acidose.
    E.2.2Secondary objectives of the trial
    - To study if sodium bicarbonate therapy in patients with metabolic
    acidosis due to chronic kidney disease effects kidney damage markers.
    - To study whether or not there is a difference in alteration of levels of
    RAS components in response to sodium bicarbonate therapy in patients
    with metabolic acidosis due to chronic kidney disease treated with AT-1
    receptor blockade and without.
    - te bekijken of sodiumbicarbonaat therapie in patienten met metabole
    acidose als gevolg van chronische nierinsufficientie nierschade-markers
    beinvloed.
    - te bestuderen of er een verschil is in verandering van RAS
    componenten na natriumbicarbonaat bij patienten met metabole acidose
    als gevolg van chronische nierinsufficientie, die behandeld worden met
    een AT-1 receptor blokker en patienten die hier niet mee behandeld
    worden
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - male or female adult (>18 years)
    - chronic kidney disease stage 4, i.e. eGFR (MDRD) 15-30 ml/min
    - plasma bicarbonate concentration of <24 and >15 meq/L, the latter
    because in that case it seems highly recommended to start
    sodiumbicarbonate suppletion and not to postpone this
    - volwassen man/vrouw (ouder dan 18 jaar)
    - chronische nierinsufficientie, stadium 4, m.a.w. eGFR (MDRD) 15-30
    ml/min
    - plasma bicarbonaat concentratie onder de 24 en boven de 15 mmol/L,
    het laatste omdat het onder de 15 aan te raden is het starten van
    natriumbicarbonaat therapie niet uit te stellen
    E.4Principal exclusion criteria
    - plasma bicarbonate level >24 meq/L or <15 meq/L
    - sodiumbicarbonate use in the 1 month preceeding the study
    - a kidney transplant in situ
    - heart failure
    - liver cirrhosis
    - resistant hypertension (blood pressure >140/90 mmHg despite the use of 3 or more different antihypertensives
    - a history of inadherence to medication
    - use of calcineurin inhibitors (these immunosuppressive drugs are
    known to induce metabolic acidosis and influence electrolytes and acidbase
    balance)
    - een plasma bicarbonaat groter dan 24mmol/L of kleiner dan 15
    mmol/L
    - natriumbicarbonaat gebruik in de maand voor de studie
    - een niertransplantaat in situ
    - hartfalen
    - levercirrose
    - therapieresistente hypertensie (bloeddruk >140/90 ondanks 3 of meer verschillende antihypertensiva
    - een voorgeschiedenis van medicatieontrouw
    - gebruik van calcineurine remmers (deze immunosuppresieve middelen
    kunnen metabole acidose induceren en beinvloeden electrolyten en zuurbase
    balans)
    E.5 End points
    E.5.1Primary end point(s)
    Study ends after 4 weeks (in which the patient recieved Sodium Bicarbonate, Sodium Chloride or none of both).
    Main study parameter is urinary renin levels.
    De studie stopt na 4 weken (waarin de patient Natriumbicarbonaat, Natriumchloride of geen van beide krijgt).
    Belangrijkste parameter is het urine-renine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    E.5.2Secondary end point(s)
    not applicable
    niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    niet van toepassing
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    tijds-controle
    time-control
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    the last visit of the last subject undergoing the trial
    laatste bezoek van laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state45
    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)
    NOT different from the expected normal treatment of that condition
    NIET anders dan gebruikelijk voor zijn/haar aandoening
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
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