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    Clinical Trial Results:
    Pharmacokinetics and side effects for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease and patients on dialysis.

    Summary
    EudraCT number
    		 2019-002786-35
    Trial protocol
    		 DK  
    Global end of trial date
    07 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Feb 2025
    First version publication date
    23 Feb 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CUA1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charlotte Uggerhøj Andersen
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 11, Aarhus N, Denmark, 8200
    Public contact
    Department of Clinical Pharmacology, Aarhus University Hospital, mbn@biomed.au.dk
    Scientific contact
    Department of Clinical Pharmacology, Aarhus University Hospital, 0045 22247983, cua@biomed.au.dk
    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
    07 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the pharmacokinetics for tetrahydrocannabinol and cannabidiol (Sativex) among patients with chronic kidney disease compared healthy volunteers.
    Protection of trial subjects
    Participants were observed at the study unit for 12 hours after administration of study medicine. Vital parameters were controlled 2 hours after administration of study medicine and side effects were assessed at regular time points over 24 hours from administration of study medicine.
    Background therapy
    		 Participants continued their usual treatments for chronic kidney disease and other diseases.
    Evidence for comparator
    		 Kidney healthy controls were used as comparator.
    Actual start date of recruitment
    29 Sep 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
    Denmark: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    44
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with chronic kidney disease were recruited from Department of Renal Medicine, Aarhus University Hospital, Denmark. Healthy controls were recruited by advertisement. We recruited participants from September 2020 until December 2023.

    Pre-assignment
    Screening details
    		 We screened medical records for patients having an appointment at the outpatient clinic at Department of Renal Medicine, Aarhus University Hospital, Denmark, to meet inclusion and exclusion criteria. 257 potential participants were assessed for eligibility of which 66 were included in the study.

    Period 1
    Period 1 title
    Prior to receiving study medicine
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy controls
    Arm description
    		 Kidney healthy controls
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 eGFR <=30 and >15
    Arm description
    		 Participants with chronic kidney disease with eGFR <=30 and >15 ml/min/1.73 m2.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 eGFR <=15
    Arm description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Haemodialysis
    Arm description
    		 Haemodialysis
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Peritoneal dialysis
    Arm description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Started
    24
    23
    11
    4
    4
    Completed
    20
    20
    10
    4
    1
    Not completed
    4
    3
    1
    0
    3
         No longer meeting inclusion/exclusion criteria
    -
    -
    -
    -
    3
         Withdrawn consent/no respond/not meeting criteria
    4
    -
    -
    -
    -
         Withdrawn consent or problems with venous access
    -
    3
    -
    -
    -
         Other (not specified due to n=1)
    -
    -
    1
    -
    -
    Period 2
    Period 2 title
    Receiving study medicine
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy controls
    Arm description
    		 Kidney healthy controls
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 eGFR <=30 and >15
    Arm description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 eGFR <=15
    Arm description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 Haemodialysis
    Arm description
    		 Haemodialysis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 Peritoneal dialysis
    Arm description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Number of subjects in period 2
    		Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Started
    20
    20
    10
    4
    1
    Completed
    20
    20
    9
    4
    1
    Not completed
    0
    0
    1
    0
    0
         Other (not specified due to n=1)
    -
    -
    1
    -
    -
    Period 3
    Period 3 title
    Completed the study
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Healthy controls
    Arm description
    		 Kidney healthy controls
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 eGFR <=30 and >15
    Arm description
    		 Participants with chronic kidney disease with eGFR <=30 and >15 ml/min/1.73 m2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 eGFR <=15
    Arm description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 Haemodialysis
    Arm description
    		 Haemodialysis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Arm title
    		 Peritoneal dialysis
    Arm description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Oromucosal use
    Dosage and administration details
    A dose of 5.4 mg of THC and 5.0 mg of CBD, corresponding to 2 sprays of Sativex, were administered to the inside of the cheek after 7 hours of fasting.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The 3 periods were needed to fill in correct data, as baseline data is provided for participants who completed the study.
    Number of subjects in period 3 [2]
    		Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Started
    20
    20
    9
    4
    1
    Completed
    20
    20
    9
    4
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline data is provided for participants who completed the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Healthy controls
    Reporting group description
    		 Kidney healthy controls

    Reporting group title
    eGFR <=30 and >15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=30 and >15 ml/min/1.73 m2.

    Reporting group title
    eGFR <=15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2

    Reporting group title
    Haemodialysis
    Reporting group description
    		 Haemodialysis

    Reporting group title
    Peritoneal dialysis
    Reporting group description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”

    Reporting group values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis Total
    Number of subjects
    		 20 20 9 4 1 54
    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 (inter-quartile range (Q1-Q3))
    		 27 (23 to 54) 64 (45 to 74) 68 (61 to 73) 68 (63 to 76) 70 (70 to 70) -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 1 2 1 18
        Male
    		 12 14 8 2 0 36
    Smoking
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 5 0 0 0 5
        No
    		 0 15 0 4 1 20
        Less than 3 in yes
    		 20 0 9 0 0 29
    urine albumin-creatinine ratio
    Units: Subjects
        30-299 mg/g
    		 0 12 4 0 0 16
        >300 mg/g
    		 0 7 5 0 0 12
        Not relevant/other
    		 20 1 0 4 1 26
    Comorbidities, diabetes
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 0 0 0 0 0
        No
    		 20 20 0 4 1 45
        Less than 3 in yes
    		 0 0 9 0 0 9
    Comorbidities, hypertension
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 17 9 0 1 27
        No
    		 0 3 0 0 0 3
        Less than 3 in yes
    		 20 0 0 4 0 24
    Comorbidities, Obesity
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 9 14 7 3 0 33
        No
    		 11 6 2 1 1 21
        Less than 3 in yes
    		 0 0 0 0 0 0
    Comorbidities, ischaemic heart disease
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 5 0 0 0 5
        No
    		 20 15 9 0 1 45
        Less than 3 in yes
    		 0 0 0 4 0 4
    Cause of CKD, hypertension
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 0 3 0 0 3
        No
    		 0 0 6 4 1 11
        Not relevant/less than 3 in yes
    		 20 20 0 0 0 40
    Cause of CKD, obstruction
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 4 0 0 0 4
        No
    		 0 16 0 4 1 21
        Not relevant/less than 3 in yes
    		 20 0 9 0 0 29
    Cause of CKD, glumerulonephritis
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 3 0 3 0 6
        No
    		 0 17 0 1 1 19
        Not relevant/less than 3 in yes
    		 20 0 9 0 0 29
    Cause of CKD, vasculitis
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 0 0 0 0 0
        No
    		 0 0 9 4 1 14
        Not relevant/less than 3 in yes
    		 20 20 0 0 0 40
    Cause of CKD, hereditary
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 4 3 0 0 7
        No
    		 0 16 6 4 1 27
        Not relevant/less than 3 in yes
    		 20 0 0 0 0 20
    Cause of CKD, other
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes" (not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 3 0 0 1 4
        No
    		 0 17 0 0 0 17
        Not relevant/less than 3 in yes
    		 20 0 9 4 0 33
    Cause of CKD, unknown
    If there is less than 3 in "yes", the number is set to "0" and all participants are placed in the group "Not relevant/less than 3 in yes"(not for the group “peritoneal dialysis”).
    Units: Subjects
        Yes
    		 0 0 0 0 0 0
        No
    		 0 0 9 4 1 14
        Not relevant/less than 3 in yes
    		 20 20 0 0 0 40
    Weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 83 (74 to 96) 88 (74 to 97) 92 (75 to 96) 109 (87 to 110) 46 (46 to 46) -
    Height
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 181 (174 to 188) 175 (168 to 180) 177 (169 to 180) 176 (164 to 192) 148 (148 to 148) -
    BMI
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 24.6 (21.6 to 27.7) 29.2 (24.0 to 31.5) 27.1 (25.6 to 30.8) 30.1 (26.4 to 36.2) 21.2 (21.2 to 21.2) -
    Waist measurement
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 92 (81 to 98) 102 (94 to 111) 103 (94 to 105) 118 (98 to 128) 77 (77 to 77) -
    Systolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 125 (115 to 140) 139 (131 to 150) 137 (129 to 153) 155 (129 to 165) 138 (138 to 138) -
    Diastolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 80 (72 to 89) 89 (82 to 93) 81 (81 to 90) 86 (77 to 89) 81 (81 to 81) -
    Heart rate
    Units: bpm
        median (inter-quartile range (Q1-Q3))
    		 68 (61 to 78) 74 (64 to 79) 69 (62 to 89) 69 (63 to 75) 87 (87 to 87) -
    Number of drugs
    Units: Number
        median (inter-quartile range (Q1-Q3))
    		 1 (0 to 2) 8 (6 to 11) 7 (6 to 8) 14 (13 to 18) 14 (14 to 14) -
    Creatinine
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: micromole(s)/litre
        median (inter-quartile range (Q1-Q3))
    		 76 (66 to 86) 256 (234 to 292) 437 (381 to 459) 99 (99 to 99) 99 (99 to 99) -
    Blood urea nitrogen
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: mmol/l
        median (inter-quartile range (Q1-Q3))
    		 4.6 (4.0 to 5.3) 16.5 (14.0 to 18.3) 17.4 (15.4 to 25.2) 99 (99 to 99) 99 (99 to 99) -
    Cystatin C
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: mg/l
        median (inter-quartile range (Q1-Q3))
    		 0.97 (0.80 to 1.08) 2.93 (2.69 to 3.25) 3.72 (3.49 to 3.82) 99 (99 to 99) 99 (99 to 99) -
    eGFR (creatinine)
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: ml/min/1.73m2
        median (inter-quartile range (Q1-Q3))
    		 107 (95 to 121) 21 (18 to 24) 11 (11 to 13) 99 (99 to 99) 99 (99 to 99) -
    eGFR (cystatine C)
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: ml/min/1.73m2
        median (inter-quartile range (Q1-Q3))
    		 94 (79 to 113) 18 (16 to 20) 13 (12 to 14) 99 (99 to 99) 99 (99 to 99) -
    eGFR (creatinene and cystatin C)
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: ml/min/1.73m2
        median (inter-quartile range (Q1-Q3))
    		 98 (86 to 114) 19 (16 to 20) 12 (11 to 12) 99 (99 to 99) 99 (99 to 99) -
    Absolute eGFR (creatinine)
    As a number must be provided, “99” is reported if the value is not relevant.
    Units: ml/min
        median (inter-quartile range (Q1-Q3))
    		 127 (100 to 139) 24 (19 to 26) 13 (13 to 14) 99 (99 to 99) 99 (99 to 99) -

    End points

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    End points reporting groups
    Reporting group title
    Healthy controls
    Reporting group description
    		 Kidney healthy controls

    Reporting group title
    eGFR <=30 and >15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=30 and >15 ml/min/1.73 m2.

    Reporting group title
    eGFR <=15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2

    Reporting group title
    Haemodialysis
    Reporting group description
    		 Haemodialysis

    Reporting group title
    Peritoneal dialysis
    Reporting group description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”
    Reporting group title
    Healthy controls
    Reporting group description
    		 Kidney healthy controls

    Reporting group title
    eGFR <=30 and >15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2

    Reporting group title
    eGFR <=15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2

    Reporting group title
    Haemodialysis
    Reporting group description
    		 Haemodialysis

    Reporting group title
    Peritoneal dialysis
    Reporting group description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”
    Reporting group title
    Healthy controls
    Reporting group description
    		 Kidney healthy controls

    Reporting group title
    eGFR <=30 and >15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=30 and >15 ml/min/1.73 m2.

    Reporting group title
    eGFR <=15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2

    Reporting group title
    Haemodialysis
    Reporting group description
    		 Haemodialysis

    Reporting group title
    Peritoneal dialysis
    Reporting group description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”

    Primary: AUC for THC

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    End point title
    		 AUC for THC
    End point description
    THC: tetrahydrocannabinol
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: h*ng/ml
        median (inter-quartile range (Q1-Q3))
    2.8 (1.8 to 3.5)
    4.2 (3.3 to 5.3)
    4.3 (3.2 to 5.4)
    2.7 (2.4 to 3.7)
    7.7 (7.7 to 7.7)
    Statistical analysis title
    		 Kruskal-Wallis test
    Comparison groups
    eGFR <=30 and >15 v eGFR <=15 v Healthy controls
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.004
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [1] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.004 [3]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [2] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [3] - Significant differences between CKD groups and healthy controls

    Secondary: AUC for CBD

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    End point title
    		 AUC for CBD
    End point description
    CBD: cannabidiol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: h*ng/ml
        median (inter-quartile range (Q1-Q3))
    1.3 (0.49 to 1.8)
    2.8 (2.5 to 3.7)
    3.6 (2.2 to 4.7)
    2.0 (1.7 to 2.5)
    6.6 (6.6 to 6.6)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    eGFR <=30 and >15 v Healthy controls v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [4] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0 [6]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [5] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [6] - Significant differences between CKD groups and healthy controls

    Secondary: AUC for THC-OH

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    End point title
    		 AUC for THC-OH
    End point description
    THC-OH: 11-hydroxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: h*ng/ml
        median (inter-quartile range (Q1-Q3))
    4.9 (2.9 to 7.0)
    19 (15 to 23)
    18 (16 to 36)
    9.2 (6.7 to 13)
    36 (36 to 36)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [7] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0 [9]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [8] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [9] - Significant differences between CKD groups and healthy controls

    Secondary: AUC for THC-COOH

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    End point title
    		 AUC for THC-COOH
    End point description
    THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: h*ng/ml
        median (inter-quartile range (Q1-Q3))
    85 (69 to 130)
    150 (110 to 190)
    130 (120 to 170)
    66 (36 to 120)
    190 (190 to 190)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 = 0.019
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [10] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.019 [12]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [11] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which
    [12] - Significant difference between eGFR <=30 and >15 and healthy controls

    Secondary: AUC for THC-COOH-glucuronide

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    End point title
    		 AUC for THC-COOH-glucuronide
    End point description
    THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: h*ng/ml
        median (inter-quartile range (Q1-Q3))
    400 (250 to 460)
    710 (600 to 1100)
    940 (720 to 1200)
    680 (390 to 930)
    1300 (1300 to 1300)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [13] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 = 0 [15]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [14] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [15] - Significant differences between CKD groups and healthy controls

    Secondary: Cmax for THC

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    End point title
    		 Cmax for THC
    End point description
    THC: Δ9-tetrahydrocannabinol Cmax: maximum concentration
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    0.62 (0.37 to 0.98)
    0.94 (0.73 to 1.5)
    1.1 (0.70 to 2.0)
    0.56 (0.34 to 0.95)
    2.1 (2.1 to 2.1)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 = 0.014
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [16] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.014 [18]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [17] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [18] - Significant differences between CKD groups and healthy controls

    Secondary: Cmax for CBD

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    End point title
    		 Cmax for CBD
    End point description
    Cmax: maximum concentration CBD: cannabidiol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    0.18 (0.12 to 0.45)
    0.68 (0.57 to 0.87)
    0.86 (0.47 to 1.3)
    0.45 (0.36 to 0.63)
    2.0 (2.0 to 2.0)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [19] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 = 0 [21]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [20] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [21] - Significant differences between CKD groups and healthy controls

    Secondary: Cmax for THC-OH

    		 Close Top of page
    End point title
    		 Cmax for THC-OH
    End point description
    Cmax: maximum concentration THC-OH: 11-hydroxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    0.91 (0.73 to 1.3)
    3.0 (2.1 to 3.9)
    2.9 (2.7 to 5.7)
    1.8 (1.2 to 2.7)
    5.5 (5.5 to 5.5)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    eGFR <=30 and >15 v Healthy controls v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [22] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 = 0 [24]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [23] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [24] - Significant differences between CKD groups and healthy controls

    Secondary: Cmax for THC-COOH

    		 Close Top of page
    End point title
    		 Cmax for THC-COOH
    End point description
    Cmax: maximum concentration THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    12 (8.1 to 14)
    16 (11 to 18)
    14 (12 to 17)
    7.1 (4.0 to 12)
    25 (25 to 25)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 = 0.02
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [25] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    P-value
    		 = 0.02 [27]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [26] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [27] - Significant difference between eGFR <=30 and >15 and healthy controls

    Secondary: Cmax for THC-COOH-glucuronide

    		 Close Top of page
    End point title
    		 Cmax for THC-COOH-glucuronide
    End point description
    Cmax: maximum concentration THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    33 (21 to 38)
    49 (40 to 61)
    59 (44 to 69)
    44 (28 to 61)
    83 (83 to 83)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [28] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 = 0 [30]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [29] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [30] - Significant differences between CKD groups and healthy controls

    Secondary: Tmax for THC

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    End point title
    		 Tmax for THC
    End point description
    Tmax: time to maximum concentration THC: Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: hours
        median (inter-quartile range (Q1-Q3))
    1.75 (1.00 to 2.50)
    1.50 (1.00 to 2.00)
    1.00 (0.75 to 1.00)
    0.88 (0.63 to 1.25)
    0.75 (0.75 to 0.75)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 = 0.041
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [31] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    P-value
    		 = 0.041 [33]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [32] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [33] - Significant difference between eGFR <=15 and healthy controls and between the two CKD groups

    Secondary: Tmax for CBD

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    End point title
    		 Tmax for CBD
    End point description
    Tmax: time to maximum concentration CBD: cannabidiol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: hours
        median (inter-quartile range (Q1-Q3))
    2.00 (0.88 to 2.75)
    1.50 (1.00 to 2.00)
    1.00 (0.75 to 1.00)
    0.88 (0.63 to 1.25)
    0.75 (0.75 to 0.75)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    P-value
    		 = 0.017
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [34] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    P-value
    		 = 0.017 [36]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [35] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [36] - Significant difference between eGFR <=15 and healthy controls

    Secondary: Tmax for THC-OH

    		 Close Top of page
    End point title
    		 Tmax for THC-OH
    End point description
    Tmax: time to maximum concentration THC-OH: 11-hydroxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: hours
        median (inter-quartile range (Q1-Q3))
    3.00 (2.00 to 3.50)
    2.50 (2.00 to 2.50)
    1.50 (1.50 to 1.50)
    1.25 (0.88 to 1.75)
    2.00 (2.00 to 2.00)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.002
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [37] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    P-value
    		 = 0.002 [39]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [38] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [39] - Significant difference between eGFR <=15 and healthy controls and between the two CKD groups

    Secondary: Tmax for THC-COOH

    		 Close Top of page
    End point title
    		 Tmax for THC-COOH
    End point description
    Tmax: time to maximum concentration THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: hours
        median (inter-quartile range (Q1-Q3))
    2.75 (2.00 to 3.50)
    2.50 (2.00 to 2.50)
    2.00 (1.50 to 2.50)
    2.00 (1.25 to 2.75)
    2.00 (2.00 to 2.00)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    P-value
    		 = 0.066
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [40] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.

    Secondary: Tmax for THC-COOH-glucuronide

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    End point title
    		 Tmax for THC-COOH-glucuronide
    End point description
    Tmax: time to maximum concentration THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    4
    1
    Units: hours
        median (inter-quartile range (Q1-Q3))
    5.00 (3.50 to 6.00)
    6.00 (5.00 to 6.00)
    6.00 (4.00 to 6.00)
    5.00 (3.75 to 6.00)
    3.00 (3.00 to 3.00)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    P-value
    		 = 0.181
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [41] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.

    Secondary: Excretion of THC-COOH in 24-hour urine

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    End point title
    		 Excretion of THC-COOH in 24-hour urine
    End point description
    THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    3
    1
    Units: microgram(s)
        median (inter-quartile range (Q1-Q3))
    2.4 (1.5 to 4.1)
    1.3 (0.34 to 2.0)
    0.79 (0.43 to 0.92)
    0 (0 to 0.21)
    0.16 (0.16 to 0.16)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    eGFR <=30 and >15 v Healthy controls v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    P-value
    		 = 0.002
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [42] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    P-value
    		 = 0.002 [44]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [43] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [44] - Significant differences between CKD groups and healthy controls

    Secondary: Excretion of THC-COOH-glucuronide in 24-hour urine

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    End point title
    		 Excretion of THC-COOH-glucuronide in 24-hour urine
    End point description
    THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    20
    20
    9
    3
    1
    Units: microgram(s)
        median (inter-quartile range (Q1-Q3))
    76 (49 to 110)
    21 (12 to 40)
    26 (21 to 27)
    2.6 (0.072 to 8.0)
    12 (12 to 12)
    Statistical analysis title
    		 Kruskal Wallis test
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    P-value
    		 = 0
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [45] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. Non-parametric test used to compare three or more distributions.
    Statistical analysis title
    		 Dunns test corrected with Bonferroni
    Comparison groups
    Healthy controls v eGFR <=30 and >15 v eGFR <=15
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other [46]
    P-value
    		 = 0 [47]
    Method
    		 Kruskal-wallis
    Confidence interval
    Notes
    [46] - Comparison between groups was prespecified, and the most appropriate statistical test was chosen later. A post-hoc pairwise comparison test used after a significant Kruskal-Wallis test to determine which specific groups differ.
    [47] - Significant differences between CKD groups and healthy controls

    Secondary: Excretion of THC-COOH in dialysate

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    End point title
    		 Excretion of THC-COOH in dialysate [48]
    End point description
    THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol No THC-COOH was detected in dialysate from haemodialysis
    End point type
    Secondary
    End point timeframe
    4 hours
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Excretion in dialysate is only reported for participants on dialysis
    End point values
    		 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    4
    1
    Units: microgram(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0.48 (0.48 to 0.48)
    No statistical analyses for this end point

    Secondary: Excretion of THC-COOH-glucuronide in dialysate

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    End point title
    		 Excretion of THC-COOH-glucuronide in dialysate [49]
    End point description
    THC-COOH: 11-nor-9-carboxy-Δ9-tetrahydrocannabinol No THC-COOH-glucuronide was detected in dialysate from haemodialysis
    End point type
    Secondary
    End point timeframe
    4 hours
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Excretion in dialysate is only reported for participants on dialysis
    End point values
    		 Haemodialysis Peritoneal dialysis
    Number of subjects analysed
    4
    1
    Units: microgram(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    0.94 (0.94 to 0.94)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported over 24 hours from administration of study medicine.
    Adverse event reporting additional description
    Numeric rating scale (NRS) questionnaires with common side effects were collected at regular time points.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Healthy controls
    Reporting group description
    		 Kidney healthy controls

    Reporting group title
    eGFR <=30 and >15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=30 and >15 ml/min/1.73 m2.

    Reporting group title
    eGFR <=15
    Reporting group description
    		 Participants with chronic kidney disease with eGFR <=15 ml/min/1.73 m2

    Reporting group title
    Haemodialysis
    Reporting group description
    		 Haemodialysis

    Reporting group title
    Peritoneal dialysis
    Reporting group description
    		 Continuous ambulatory peritoneal dialysis and automated peritoneal dialysis with “wet day”

    Serious adverse events
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    0 / 10 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Healthy controls eGFR <=30 and >15 eGFR <=15 Haemodialysis Peritoneal dialysis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 20 (90.00%)
    13 / 20 (65.00%)
    8 / 10 (80.00%)
    3 / 4 (75.00%)
    1 / 1 (100.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    10 / 20 (50.00%)
    10 / 20 (50.00%)
    6 / 10 (60.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
         occurrences all number
    10
    10
    6
    1
    1
    Intoxicated/high
         subjects affected / exposed
    9 / 20 (45.00%)
    8 / 20 (40.00%)
    5 / 10 (50.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    8
    5
    0
    0
    Concentration impairment
         subjects affected / exposed
    8 / 20 (40.00%)
    6 / 20 (30.00%)
    2 / 10 (20.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    8
    6
    2
    0
    0
    Headache
         subjects affected / exposed
    3 / 20 (15.00%)
    4 / 20 (20.00%)
    1 / 10 (10.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    4
    1
    1
    0
    Sleepiness
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    2 / 10 (20.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
         occurrences all number
    3
    3
    2
    1
    1
    Confusion
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 20 (20.00%)
    2 / 10 (20.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    4
    2
    0
    0
    Affection of vision and hearing
         subjects affected / exposed
    4 / 20 (20.00%)
    1 / 20 (5.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    1
    1
    0
    0
    Affection of body movement control
         subjects affected / exposed
    1 / 20 (5.00%)
    4 / 20 (20.00%)
    1 / 10 (10.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    2 / 10 (20.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    3
    2
    1
    0

    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.
    The intended number of participants could not be included. Baseline data varied considerable between groups. Healthy controls were significantly younger than other groups. Only a single-dose study with a low dose of both THC and CBD.
    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.

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