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    Clinical Trial Results:
    "Efecto del ARA-II Olmesartan sobre el metabolismo del potasio en pacientes con insuficiencia renal crónica"

    Summary
    EudraCT number
    		 2008-002191-98
    Trial protocol
    		 ES  
    Global end of trial date
    28 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Dec 2021
    First version publication date
    19 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PREVARENAL-08
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Eugenia Espinel, VHIR, eespinel@vhebron.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
    30 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effects of administration of an inhibitor of angiotensin converting enzyme with an atagonist of AT1 receptors of angiotensin, on plasma potassium levels. Comparar el efecto de la administración de un inhibidor del enzima de conversión del angiotensina con un antagonista de los receptores AT1 de la angiotensina, sobre los niveles de potasio plasmáticos.
    Protection of trial subjects
    Each patient was visited 10 times throughout the study to avoid severe complications. Routien analysis at each visit included cereatinine, potassium, sodium and osmolarity in serum, and albumin, creatinine, sodium and potassium in urine. No patient with arterial stenosis was included.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2009
    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
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Stage 3 CKD patients with stable condition, GFR 30-60 ml/min/1.73 m2, aged 18-75 years, serum potassium concentration <5 mmol/L, blood pressure 130/80 -180/100 mmHg were considered for inclusion. Use of calcium channel blockers or alpha-adrenergic blockers were not exclusion criteria. 4 patients were excluded for not following a salt balanced diet

    Period 1
    Period 1 title
    First treatment OLM ENA
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 OLMERSATAN
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olmersatan
    Investigational medicinal product code
    Other name
    Openvas
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg orally daily for 1 week

    Number of subjects in period 1
    		OLMERSATAN
    Started
    30
    Completed
    27
    Not completed
    3
         Protocol deviation
    3
    Period 2
    Period 2 title
    Second treatment OLM ENA
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Arm title
    		 Enalapril
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enalapril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg orally daily for 1 week

    Number of subjects in period 2
    		Enalapril
    Started
    27
    Completed
    20
    Not completed
    7
         Protocol deviation
    7

    Baseline characteristics

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

    Reporting group values
    		 OLMERSATAN Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 60.2 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    OLMERSATAN
    Reporting group description
    		 -
    Reporting group title
    Enalapril
    Reporting group description
    		 -

    Primary: Plasma Potassium Increase

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    End point title
    		 Plasma Potassium Increase
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 OLMERSATAN Enalapril
    Number of subjects analysed
    27
    20
    Units: nmol/l
        number (not applicable)
    0.24
    0.30
    Statistical analysis title
    		 Potassium increase
    Comparison groups
    OLMERSATAN v Enalapril
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Microalbuminuria decrease

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    End point title
    		 Microalbuminuria decrease
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 OLMERSATAN Enalapril
    Number of subjects analysed
    27
    20
    Units: percent
        number (not applicable)
    23
    29
    Statistical analysis title
    		 Microalbuminuria
    Comparison groups
    OLMERSATAN v Enalapril
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 30 (13.33%)
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4

    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.
    Stage 3 CKD patients treated with these drugs should also be controlled at the end of month 1 and 2. After that point, patients should be controlled at the periods recommended at guidelines, to follow-up stable stage 3 CKD patients, and also when a c

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23915518
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    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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