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    Clinical Trial Results:
    A PROSPECTIVE, RANDOMIZED, CROSS-OVER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE ANTIPROTEINURIC EFFECT OF SELECTIVE VITAMIN D RECEPTOR ACTIVATION BY PARICALCITOL IN TYPE 2 DIABETES PATIENTS ON LOW OR HIGH SODIUM DIET AND STABLE RAS INHIBITOR THERAPY

    Summary
    EudraCT number
    		 2011-001713-14
    Trial protocol
    		 IT  
    Global end of trial date
    29 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2019
    First version publication date
    02 Jun 2019
    Other versions
    Summary report(s)
    		 Paper Lancet Diabetes Endocrinol 2017
    Supplementary appendix

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PROCEED
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01393808
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Istituto di Ricerche Farmacologiche Mario Negri IRCCS
    Sponsor organisation address
    via G. La Masa 19, Milano MI, Italy, 20156
    Public contact
    Laboratorio attività regolatorie relative agli studi clinici, Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, 0039 035 453531, paola.boccardo@marionegri.it
    Scientific contact
    Laboratorio attività regolatorie relative agli studi clinici, Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò, 0039 035 453531, paola.boccardo@marionegri.it
    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 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The broad aim of this study was to evaluate the interaction between paricalcitol therapy and sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable background RAS inhibitor therapy. The primary aim was to compare changes in Urinary Albumin Excretion (UAE) rate achieved by one month paricalcitol therapy vs placebo in patients on stable Renin-Angiotensin System (RAS) inhibitor therapy on high (>200 mEq/day) or low (<100 mEq/day) sodium intake.
    Protection of trial subjects
    This study was conducted in conformance with Declaration of Helsinki, Good Clinical Practice standards and applicable country regulations regarding ethical committee review, informed consent, protection of human subjects participating in biomedical research and privacy. We assessed by monitoring of vital signs, physical examination, (BP and heart rate), laboratory tests, adverse event data and documentation of additional medication use, assessed at baseline and at the end of each monthly visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2011
    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
    Italy: 115
    Worldwide total number of subjects
    115
    EEA total number of subjects
    115
    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)
    56
    From 65 to 84 years
    59
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 All participating centers in Italy were activated between September and October 2011. The recruitment started on October 13, 2011 and concluded on December 18, 2014.

    Pre-assignment
    Screening details
    		 195 subjects were screened for inclusion in the study. 115 subjects were randomized. Of those not randomised , 55 did not meet inclusion criteria, 1 was lost to follow up, 22 declined to participate and 2 were excluded for concomitant diseases.

    Period 1
    Period 1 title
    Treatment Period 1 (1 month)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A - Stratum Low Sodium Diet Paricalcitol
    Arm description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during Treatment period 1 and received Placebo tablets twice daily for 1 month during Treatment period 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Group B - Stratum Low Sodium Diet Placebo
    Arm description
    		 Participants received placebo tablets twice daily for 1 month during Treatment period 1 and received Paricalcitol 1 micrograms tablets twice daily for 1 month during Treatment period 3. There is one-month wash-out period between Treatment periods 1 and 3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Arm title
    		 Group C - Stratum High Sodium Diet Paricalcitol
    Arm description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 1 and received Placebo twice daily for 1 month during treatment period 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Group D - Stratum High Sodium Diet Placebo
    Arm description
    		 Participants received placebo tablets twice daily for 1 month during treatment period 1 and received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Number of subjects in period 1
    		Group A - Stratum Low Sodium Diet Paricalcitol Group B - Stratum Low Sodium Diet Placebo Group C - Stratum High Sodium Diet Paricalcitol Group D - Stratum High Sodium Diet Placebo
    Started
    28
    29
    29
    29
    Completed
    28
    28
    28
    27
    Not completed
    0
    1
    1
    2
         Consent withdrawn by subject
    -
    1
    1
    1
         Protocol deviation
    -
    -
    -
    1
    Period 2
    Period 2 title
    Treatment period 2 (1 month - washout)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Group A - Stratum Low Sodium Diet placebo
    Arm description
    		 Participants received Placebo tablets orally twice daily for 1 month (for patients that were on Paricalcitol during previous period)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Group B - Stratum Low Sodium Diet placebo
    Arm description
    		 Participants received Placebo tablets orally twice daily for 1 month (for patients that were on Placebo during previous period)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Group C - Stratum High Sodium Diet placebo
    Arm description
    		 Participants received Placebo tablets ( for patients that were on Paricalcitol during previous period)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Group D - Stratum High Sodium Diet placebo
    Arm description
    		 Participants received Placebo tablets twice daily for 1 month (for patients that were on Placebo during previous period)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Number of subjects in period 2
    		Group A - Stratum Low Sodium Diet placebo Group B - Stratum Low Sodium Diet placebo Group C - Stratum High Sodium Diet placebo Group D - Stratum High Sodium Diet placebo
    Started
    28
    28
    28
    27
    Completed
    27
    28
    28
    27
    Not completed
    1
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    Period 3
    Period 3 title
    Treatment period 3 (1 month)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A - Stratum Low Sodium Diet Placebo
    Arm description
    		 Participants received placebo tablets twice daily for 1 month during treatment period 3 and received Paricalcitol 1 microgram tablets twice daily for 1 month during tratment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Arm title
    		 Group B - Stratum Low Sodium Diet Paricalcitol
    Arm description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3 and received placebo tablets twice daily for 1 month during treatment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Group C - Stratum High Sodium Diet Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Arm title
    		 Group D - Stratum Low Sodium Diet Paricalcitol
    Arm description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3 and received Placebo tablets twice daily for 1 month during treatment period 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Number of subjects in period 3
    		Group A - Stratum Low Sodium Diet Placebo Group B - Stratum Low Sodium Diet Paricalcitol Group C - Stratum High Sodium Diet Placebo Group D - Stratum Low Sodium Diet Paricalcitol
    Started
    27
    28
    28
    27
    Completed
    27
    26
    28
    27
    Not completed
    0
    2
    0
    0
         Lost to follow-up
    -
    2
    -
    -
    Period 4
    Period 4 title
    Stratification and Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Low Sodium Diet
    Arm description
    		 Participants stratified for Low sodium diet (Paricalcitol and Placebo)
    Arm type
    		 Diet

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 High Sodium Diet
    Arm description
    		 Participants stratified for High sodium diet (Paricalcitol and Placebo)
    Arm type
    		 Diet

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Paricalcitol in High Sodium Diet
    Arm description
    		 Participants stratified for High sodium diet who took in Paricalcitol regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Arm title
    		 Placebo in High Sodium Diet
    Arm description
    		 Participants stratified for High sodium diet who took in Placebo regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Arm title
    		 Paricalcitol in Low Sodium diet
    Arm description
    		 Participants stratified for Low sodium diet who took in Paricalcitol regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Zemplar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Paricalcitol 1 microgram tablets orally twice daily for 1 month.

    Arm title
    		 Placebo in Low Sodium Diet
    Arm description
    		 Participants stratified for Low sodium diet who took in Placebo regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablets orally twice daily for 1 month.

    Number of subjects in period 4
    		Low Sodium Diet High Sodium Diet Paricalcitol in High Sodium Diet Placebo in High Sodium Diet Paricalcitol in Low Sodium diet Placebo in Low Sodium Diet
    Started
    57
    58
    58
    58
    57
    57
    Completed
    53
    55
    55
    55
    53
    53
    Not completed
    4
    3
    3
    3
    4
    4
         Consent withdrawn by subject
    2
    2
    2
    2
    2
    2
         Lost to follow-up
    2
    -
    -
    -
    2
    2
         Protocol deviation
    -
    1
    1
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group A - Stratum Low Sodium Diet Paricalcitol
    Reporting group description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during Treatment period 1 and received Placebo tablets twice daily for 1 month during Treatment period 3.

    Reporting group title
    Group B - Stratum Low Sodium Diet Placebo
    Reporting group description
    		 Participants received placebo tablets twice daily for 1 month during Treatment period 1 and received Paricalcitol 1 micrograms tablets twice daily for 1 month during Treatment period 3. There is one-month wash-out period between Treatment periods 1 and 3

    Reporting group title
    Group C - Stratum High Sodium Diet Paricalcitol
    Reporting group description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 1 and received Placebo twice daily for 1 month during treatment period 3.

    Reporting group title
    Group D - Stratum High Sodium Diet Placebo
    Reporting group description
    		 Participants received placebo tablets twice daily for 1 month during treatment period 1 and received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3.

    Reporting group values
    		 Group A - Stratum Low Sodium Diet Paricalcitol Group B - Stratum Low Sodium Diet Placebo Group C - Stratum High Sodium Diet Paricalcitol Group D - Stratum High Sodium Diet Placebo Total
    Number of subjects
    		 28 29 29 29 115
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 11 16 14 15 56
        From 65-84 years
    		 17 13 15 14 59
        85 years and over
    		 0 0 0 0 0
        age
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ± 6.3 64.2 ± 8.2 64.2 ± 10.8 64.1 ± 9.1 -
    Gender categorical
    Units: Subjects
        Female
    		 0 3 6 4 13
        Male
    		 28 26 23 25 102
    Patients taking Losartan alone
    Units: Subjects
        Monotherapy
    		 2 6 4 7 19
        No monotherapy
    		 26 23 25 22 96
    Smoke
    Units: Subjects
        Never
    		 6 3 4 11 24
        Current
    		 7 12 10 6 35
        Former
    		 15 14 15 12 56
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 31.2 ± 3.5 31.4 ± 5.0 29.1 ± 4.0 31.7 ± 6.1 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 90.7 ± 13.7 91.5 ± 16.7 81.1 ± 14.6 88.7 ± 18.8 -
    Systolic Blood Pressure
    Units: mm HG
        arithmetic mean (standard deviation)
    		 147.6 ± 12.0 148.2 ± 14.1 146.3 ± 11.4 143.1 ± 12.6 -
    Diastolic Blood Pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 81.1 ± 5.4 79.0 ± 7.0 79.8 ± 5.9 77.9 ± 5.2 -
    Mean Blood Pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 102.9 ± 6.8 102.5 ± 7.8 101.6 ± 6.5 99.3 ± 6.4 -
    Serum calcium
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 9.1 ± 0.3 9.1 ± 0.4 9.3 ± 0.3 9.2 ± 0.3 -
    Serum Phosphorus
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 3.3 ± 0.4 3.3 ± 0.6 3.5 ± 0.5 3.4 ± 0.5 -
    Serum iPTH
    Units: pg/mL
        arithmetic mean (standard deviation)
    		 50.0 ± 22.4 50.0 ± 20.0 42.1 ± 22.1 48.2 ± 23.2 -
    Serum 25OH vit D
    Units: ng/mL
        arithmetic mean (standard deviation)
    		 12.25 ± 5.7 12.1 ± 6.4 10.6 ± 4.6 12.8 ± 6.6 -
    Serum Glucose
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 148.7 ± 41.4 149.6 ± 47.9 163.8 ± 65.0 151.3 ± 56.3 -
    HbA1C
    Units: Percentual
        arithmetic mean (standard deviation)
    		 7.7 ± 3.4 7.4 ± 3.2 7.8 ± 3.7 7.0 ± 3.4 -
    Serum potassium
    Units: meq/L
        arithmetic mean (standard deviation)
    		 4.0 ± 0.5 4.2 ± 0.6 4.2 ± 0.6 4.1 ± 0.4 -
    Total cholesterol
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 166.9 ± 48.3 171.9 ± 32.7 174.7 ± 40.7 176.9 ± 34.4 -
    HDL cholesterol
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 42.5 ± 12.1 41 ± 9.6 47.5 ± 14.2 43 ± 13.3 -
    LDL cholesterol
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 94.7 ± 37.2 105.4 ± 32.0 107.2 ± 36.2 105.1 ± 24.4 -
    Triglycerides
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 177.7 ± 140.5 164.6 ± 71.1 134.8 ± 78.5 178.5 ± 125.3 -
    Hemoglobin
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 13.8 ± 1.4 13.7 ± 1.5 13.5 ± 1.5 13.1 ± 1.8 -
    24 h urinary calcium excretion
    Units: mg
        median (inter-quartile range (Q1-Q3))
    		 82.7 (43.9 to 123.3) 90.6 (41.1 to 149.7) 76.3 (45.0 to 116.2) 67.6 (55.0 to 136.2) -
    Glomerular Filtration Rate
    Units: mL/min/1.73m2
        arithmetic mean (standard deviation)
    		 87.33 ± 21.14 94.22 ± 33.08 81.51 ± 26.27 86.37 ± 34.51 -
    24 h urinary phosphorus excretion
    Units: mg
        median (inter-quartile range (Q1-Q3))
    		 617.7 (542.7 to 828.5) 763.1 (546.0 to 986.2) 634.3 (429.2 to 860.8) 779.3 (539.1 to 914.5) -
    24 h urinary albumin excretion
    Units: mg
        median (inter-quartile range (Q1-Q3))
    		 749 (402 to 1493) 724 (449 to 1198) 750 (505 to 1338) 658 (389 to 1058) -
    24 h albumin-to-creatinine ratio
    Units: mg/g
        median (inter-quartile range (Q1-Q3))
    		 447.0 (355.9 to 1070.9) 548.5 (254.1 to 693.9) 604.3 (421.8 to 806.9) 458.5 (240.7 to 683.3) -
    Urinary Sodium Excretion
    Units: mEq/24h
        median (inter-quartile range (Q1-Q3))
    		 184.4 (157.4 to 229.6) 203.1 (173.5 to 223.4) 200.2 (151.3 to 226.5) 181.8 (144.4 to 223.5) -

    End points

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    End points reporting groups
    Reporting group title
    Group A - Stratum Low Sodium Diet Paricalcitol
    Reporting group description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during Treatment period 1 and received Placebo tablets twice daily for 1 month during Treatment period 3.

    Reporting group title
    Group B - Stratum Low Sodium Diet Placebo
    Reporting group description
    		 Participants received placebo tablets twice daily for 1 month during Treatment period 1 and received Paricalcitol 1 micrograms tablets twice daily for 1 month during Treatment period 3. There is one-month wash-out period between Treatment periods 1 and 3

    Reporting group title
    Group C - Stratum High Sodium Diet Paricalcitol
    Reporting group description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 1 and received Placebo twice daily for 1 month during treatment period 3.

    Reporting group title
    Group D - Stratum High Sodium Diet Placebo
    Reporting group description
    		 Participants received placebo tablets twice daily for 1 month during treatment period 1 and received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3.
    Reporting group title
    Group A - Stratum Low Sodium Diet placebo
    Reporting group description
    		 Participants received Placebo tablets orally twice daily for 1 month (for patients that were on Paricalcitol during previous period)

    Reporting group title
    Group B - Stratum Low Sodium Diet placebo
    Reporting group description
    		 Participants received Placebo tablets orally twice daily for 1 month (for patients that were on Placebo during previous period)

    Reporting group title
    Group C - Stratum High Sodium Diet placebo
    Reporting group description
    		 Participants received Placebo tablets ( for patients that were on Paricalcitol during previous period)

    Reporting group title
    Group D - Stratum High Sodium Diet placebo
    Reporting group description
    		 Participants received Placebo tablets twice daily for 1 month (for patients that were on Placebo during previous period)
    Reporting group title
    Group A - Stratum Low Sodium Diet Placebo
    Reporting group description
    		 Participants received placebo tablets twice daily for 1 month during treatment period 3 and received Paricalcitol 1 microgram tablets twice daily for 1 month during tratment period 1.

    Reporting group title
    Group B - Stratum Low Sodium Diet Paricalcitol
    Reporting group description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3 and received placebo tablets twice daily for 1 month during treatment period 1.

    Reporting group title
    Group C - Stratum High Sodium Diet Placebo
    Reporting group description
    		 -

    Reporting group title
    Group D - Stratum Low Sodium Diet Paricalcitol
    Reporting group description
    		 Participants received Paricalcitol 1 microgram tablets twice daily for 1 month during treatment period 3 and received Placebo tablets twice daily for 1 month during treatment period 1.
    Reporting group title
    Low Sodium Diet
    Reporting group description
    		 Participants stratified for Low sodium diet (Paricalcitol and Placebo)

    Reporting group title
    High Sodium Diet
    Reporting group description
    		 Participants stratified for High sodium diet (Paricalcitol and Placebo)

    Reporting group title
    Paricalcitol in High Sodium Diet
    Reporting group description
    		 Participants stratified for High sodium diet who took in Paricalcitol regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)

    Reporting group title
    Placebo in High Sodium Diet
    Reporting group description
    		 Participants stratified for High sodium diet who took in Placebo regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)

    Reporting group title
    Paricalcitol in Low Sodium diet
    Reporting group description
    		 Participants stratified for Low sodium diet who took in Paricalcitol regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)

    Reporting group title
    Placebo in Low Sodium Diet
    Reporting group description
    		 Participants stratified for Low sodium diet who took in Placebo regardless of the IMP randomization sequence (Paricalcitol/Placebo or Placebo/Paricalcitol)

    Primary: Changes in UAE rate between patients on paricalcitol and placebo on high (>200 mEq/day) or low (<100 mEq/day) sodium intake.

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    End point title
    		 Changes in UAE rate between patients on paricalcitol and placebo on high (>200 mEq/day) or low (<100 mEq/day) sodium intake.
    End point description
    24 h urinary albumin excretion absolute change
    End point type
    Primary
    End point timeframe
    Baseline is at the start of treatment and after treatment is after the 1 month of Paricalcitol or Placebo treatment
    End point values
    		 Low Sodium Diet High Sodium Diet
    Number of subjects analysed
    53
    55
    Units: mg/24h
        median (inter-quartile range (Q1-Q3))
    -33.1 (-128.2 to 56.2)
    -108.0 (-273.6 to -24.5)
    Statistical analysis title
    		 Changes in UAE
    Statistical analysis description
    Changes in UAE between paricalcitol and placebo period, over sodium intake
    Comparison groups
    Low Sodium Diet v High Sodium Diet
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.09 [1]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - The report p-value is referred to overall patients changes in UAE between paricalcitol and placebo periods. Changes in patients on High Sodium Diet reported a p-value of 0.09, while changes in patients on Low Sodium Diet reported a p-value of 0.55.

    Post-hoc: Changes in UAE at the end of the treatment period 1 (1 month) as compared to baseline in patients on Stratum Low Sodium orHigh Sodium independently of treatment allocation to Placebo or Paricalcitol

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    End point title
    		 Changes in UAE at the end of the treatment period 1 (1 month) as compared to baseline in patients on Stratum Low Sodium orHigh Sodium independently of treatment allocation to Placebo or Paricalcitol
    End point description
    End point type
    Post-hoc
    End point timeframe
    Baseline to the end of first month of treatment.
    End point values
    		 Low Sodium Diet High Sodium Diet
    Number of subjects analysed
    56 [2]
    55 [3]
    Units: mg
        median (inter-quartile range (Q1-Q3))
    -144 (-217.4 to -102.2)
    -49 (-201.6 to 21.6)
    Notes
    [2] - 1 withdrew consent
    [3] - 2 withdrew consent and 1 violated protocol
    No statistical analyses for this end point

    Post-hoc: Changes in UAE at the end of the washout period (1 month) as compared to baseline in patients on Stratum Low Sodium orHigh Sodium independently of treatment allocation to Placebo or Paricalcitol

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    End point title
    		 Changes in UAE at the end of the washout period (1 month) as compared to baseline in patients on Stratum Low Sodium orHigh Sodium independently of treatment allocation to Placebo or Paricalcitol
    End point description
    End point type
    Post-hoc
    End point timeframe
    Baseline to the second month of treatment.
    End point values
    		 Low Sodium Diet High Sodium Diet
    Number of subjects analysed
    55 [4]
    55 [5]
    Units: mg
        median (inter-quartile range (Q1-Q3))
    -106.6 (-181.4 to -69.1)
    -13 (-115.2 to 116.6)
    Notes
    [4] - 1 withdrew consent during the washout period
    [5] - 2 withdtrew consent and 1 violated protocol during the period 1
    No statistical analyses for this end point

    Post-hoc: Changes in UAE at the end of the treatment period 3 (1 month) as compared to baseline in patients on Stratum Low Sodium orHigh Sodium independently of treatment allocation to Placebo or Paricalcitol

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    End point title
    		 Changes in UAE at the end of the treatment period 3 (1 month) as compared to baseline in patients on Stratum Low Sodium orHigh Sodium independently of treatment allocation to Placebo or Paricalcitol
    End point description
    End point type
    Post-hoc
    End point timeframe
    Baseline to end of third month of treatment.
    End point values
    		 Low Sodium Diet High Sodium Diet
    Number of subjects analysed
    53 [6]
    55
    Units: mg
        median (inter-quartile range (Q1-Q3))
    -273.6 (-385.9 to -151.2)
    20.2 (-128.2 to 93.6)
    Notes
    [6] - 2 lost to follow-up during the third period
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events will be reported during whole study up to 30 days after last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo tablets twice daily for 1 month, regardless of sequence.

    Reporting group title
    Paricalcitol
    Reporting group description
    		 Patients received Paricalcitol 1 microgram tablets twice daily for 1 month, regardless of sequence.

    Serious adverse events
    		 Placebo Paricalcitol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 115 (1.74%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Ischaemic heart disease
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stroke
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Paricalcitol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 115 (31.30%)
    51 / 115 (44.35%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 115 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Tinnitus, hands tingling, or dizziness
         subjects affected / exposed
    2 / 115 (1.74%)
    1 / 115 (0.87%)
         occurrences all number
    2
    1
    Fever or asthenia (unspecified)
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 115 (1.74%)
         occurrences all number
    0
    2
    Immune system disorders
    Allergic reactions, urticaria, or pruritus
         subjects affected / exposed
    1 / 115 (0.87%)
    1 / 115 (0.87%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Flu-like symptoms, cough, bronchitis, or synusitis
         subjects affected / exposed
    2 / 115 (1.74%)
    7 / 115 (6.09%)
         occurrences all number
    2
    7
    Cardiac disorders
    Legs oedema
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache or migraine
         subjects affected / exposed
    1 / 115 (0.87%)
    2 / 115 (1.74%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Thrombocytopenia or anaemia
         subjects affected / exposed
    2 / 115 (1.74%)
    1 / 115 (0.87%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Gastroenteritis, diarrhoea, or abdominal pain
         subjects affected / exposed
    1 / 115 (0.87%)
    2 / 115 (1.74%)
         occurrences all number
    1
    2
    Worsening symptoms of ulcerous colitis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Hypophosphaturia
         subjects affected / exposed
    2 / 115 (1.74%)
    2 / 115 (1.74%)
         occurrences all number
    2
    2
    Dermatitis and skin infection
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 115 (1.74%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    Urinary tract infection or macrohaematuria
         subjects affected / exposed
    2 / 115 (1.74%)
    1 / 115 (0.87%)
         occurrences all number
    2
    1
    Endocrine disorders
    Low serum iPTH concentration
         subjects affected / exposed
    0 / 115 (0.00%)
    3 / 115 (2.61%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Lumbar pain or cramps
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 115 (1.74%)
         occurrences all number
    0
    2
    Osteoarthritis and trigger finger
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
         occurrences all number
    0
    2
    Traumatic pain or tendon tear
         subjects affected / exposed
    1 / 115 (0.87%)
    1 / 115 (0.87%)
         occurrences all number
    1
    1
    Infections and infestations
    Herpes zoster infection
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 115 (0.87%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypercalciuria
         subjects affected / exposed
    1 / 115 (0.87%)
    14 / 115 (12.17%)
         occurrences all number
    1
    14
    Hypocalciuria
         subjects affected / exposed
    11 / 115 (9.57%)
    3 / 115 (2.61%)
         occurrences all number
    11
    3
    Hyperphosphaturia
         subjects affected / exposed
    6 / 115 (5.22%)
    2 / 115 (1.74%)
         occurrences all number
    6
    2
    Hypercalcaemia
         subjects affected / exposed
    0 / 115 (0.00%)
    6 / 115 (5.22%)
         occurrences all number
    0
    6
    Hyperphosphataemia
         subjects affected / exposed
    0 / 115 (0.00%)
    5 / 115 (4.35%)
         occurrences all number
    0
    5
    Hypokalaemia, hyperhomocysteinemia, or low bone alkaline phosphate concentration
         subjects affected / exposed
    1 / 115 (0.87%)
    2 / 115 (1.74%)
         occurrences all number
    1
    2
    Hypocalcaemia
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 115 (0.00%)
         occurrences all number
    2
    0
    Hypophosphataemia
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 115 (0.00%)
         occurrences all number
    2
    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29104158
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