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    Clinical Trial Results:
    Efficacy and safety of paricalcitol in the reduction of secondary hyperparathyroidism after renal transplantation.

    Summary
    EudraCT number
    		 2013-001326-25
    Trial protocol
    		 ES  
    Global end of trial date
    09 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2020
    First version publication date
    26 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACA-SPAI-11-24
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01939977
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación SENEFRO
    Sponsor organisation address
    Calle Calvo Sotelo, 19 3ª planta, Santander, Spain, 39002
    Public contact
    Josep M Cruzado, Hospital Universitari de Bellvitge, 34 932607602, jmcruzado@bellvitgehospital.cat
    Scientific contact
    Josep M Cruzado, Hospital Universitari de Bellvitge, 34 932607602, jmcruzado@bellvitgehospital.cat
    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
    09 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
    Protection of trial subjects
    The study was in compliance with ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 in both treatment groups, the patients received standard treatment for transplant patients, which should include immunosuppression with tacrolimus, mycophenolate mofetil or mycophenolic acid and steroids.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 148
    Worldwide total number of subjects
    148
    EEA total number of subjects
    148
    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)
    93
    From 65 to 84 years
    55
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First randomization took place on 07/01/2014 and the last randomization took place on 27/02/2015. 148 patients were screened; 94 were randomized at 13 sites. 1 patient did not receive the study treatment.

    Pre-assignment
    Screening details
    		 Signed IC;Age>18 years;Candidates to an immediately renal transplantation from living or deceased donor;Significant grade of hyperparathyroidism;Preformed antibody panel<20%;Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation;Patients treated with immunosupresion (not treated with mTOR inhibitors)

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding techniques are applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Paricalcitol
    Arm description
    		 Paricalcitol oral, 1 µg/day (Zemplar®, Abbvie Inc. North Chicago, Illinois, USA), plus the standard treatment for a renal transplant recipient. The starting dose of paricalcitol was 1 µg/day, but this dose was adjusted based on the serum iPTH and Ca* levels
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paricalcitol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The patients assigned to Group 1 of treatment received 1 µg/day of paricalcitol as of the first day they tolerate oral nutrition, within the first week post-transplant. The dose of paricalcitol was adjusted based on the levels of serum iPTH and calcium: If after the first month (M1 Visit), the serum levels of iPTH exceed 100 pg/ml and serum calcium is less than or equal to 10 mg/dl, the dose of paricalcitol will be increased to 2 µg/day, with strict control of serum iPTH and calcium. If the calcium levels exceed 10.3 mg/dL, and the iPTH is ≤ 110 pg/ml, the dose of paricalcitol will be reduced to 1 µg on alternate days (1 µg of paricalcitol every 48h). If, on the other hand, with those levels of calcium the iPTH > 110 pg/ml, the patient will be considered to not be responding to the treatment and, therefore, will leave the treatment and complete the End-of Study Visit. This adjustment will also apply at the M3 Visit if necessary.

    Arm title
    		 Calcifediol
    Arm description
    		 Calcifediol oral (Hidroferol®, FAES FARMA, Spain), plus the standard treatment for a renal transplant recipient. The starting dose was 5 drops (20 µg or 1200 IU) and the maintenance dose was adjusted based on the 25(OH)D levels.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Calcifediol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    The patients assigned to Calcifediol of treatment received 5 drops of calcifediol per day (20 µg or 1200 IU) as of the first day they tolerate oral nutrition, within the first week post-transplant. The dose of calcifediol was adjusted based on the 25(OH)D levels measured at visits M1 and M3. Therefore: If, at the M1 Visit, the 25(OH)D levels are ≥ 30 ng/ml, the patients will continue receiving 5 drops per day of oral calcifediol until the end of the study. If, at the M1 Visit, the 25(OH)D levels are < 30 ng/ml, the patients switched to receive 7 drops per day of calcifediol until the M3 Visit. If, at the M3 Visit, the 25(OH)D levels are ≥ 30 ng/ml, the patients switched to receive 5 drops per day of calcifediol until the end of the study. If, at the M3 Visit, the 25(OH)D levels continue to be < 30 ng/ml, the patients continued receiving 7 drops per day of calcifediol until the end of the study.

    Number of subjects in period 1 [1]
    		Paricalcitol Calcifediol
    Started
    46
    47
    Completed
    37
    41
    Not completed
    9
    6
         Physician decision
    1
    1
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    4
    3
         Lack of efficacy
    3
    -
         Protocol deviation
    1
    -
    Notes
    [1] - 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: 54 patients were failure of screening and 1 patient was not treated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Paricalcitol
    Reporting group description
    		 Paricalcitol oral, 1 µg/day (Zemplar®, Abbvie Inc. North Chicago, Illinois, USA), plus the standard treatment for a renal transplant recipient. The starting dose of paricalcitol was 1 µg/day, but this dose was adjusted based on the serum iPTH and Ca* levels

    Reporting group title
    Calcifediol
    Reporting group description
    		 Calcifediol oral (Hidroferol®, FAES FARMA, Spain), plus the standard treatment for a renal transplant recipient. The starting dose was 5 drops (20 µg or 1200 IU) and the maintenance dose was adjusted based on the 25(OH)D levels.

    Reporting group values
    		 Paricalcitol Calcifediol Total
    Number of subjects
    		 46 47 93
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 28 29 57
        From 65-84 years
    		 18 18 36
    Age continuous
    Units: years
        median (full range (min-max))
    		 62.5 (21 to 78) 56.0 (27 to 78) -
    Gender categorical
    Units: Subjects
        Female
    		 14 16 30
        Male
    		 32 31 63
    Smoking
    Units: Subjects
        Non smoker
    		 20 25 45
        Former smoker
    		 15 14 29
        Smoker
    		 11 8 19
    Alcohol intake
    Units: Subjects
        Abstemious
    		 38 37 75
        Occasional
    		 8 7 15
        Regular
    		 0 3 3
    First renal transplant
    Units: Subjects
        Yes
    		 43 44 87
        No
    		 3 3 6
    Type of transplant
    Units: Subjects
        Living donor
    		 9 11 20
        Deceased donor
    		 37 36 73
    Donor gender
    Units: Subjects
        Male
    		 20 23 43
        Female
    		 25 23 48
        Unknown
    		 1 1 2
    Donor age
    Units: years
        median (full range (min-max))
    		 64 (21 to 85) 60 (11 to 80) -

    End points

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    End points reporting groups
    Reporting group title
    Paricalcitol
    Reporting group description
    		 Paricalcitol oral, 1 µg/day (Zemplar®, Abbvie Inc. North Chicago, Illinois, USA), plus the standard treatment for a renal transplant recipient. The starting dose of paricalcitol was 1 µg/day, but this dose was adjusted based on the serum iPTH and Ca* levels

    Reporting group title
    Calcifediol
    Reporting group description
    		 Calcifediol oral (Hidroferol®, FAES FARMA, Spain), plus the standard treatment for a renal transplant recipient. The starting dose was 5 drops (20 µg or 1200 IU) and the maintenance dose was adjusted based on the 25(OH)D levels.

    Primary: iPTH serum concentration

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    End point title
    		 iPTH serum concentration
    End point description
    Percentage of patients with iPTH serum concentration > 110 pg/ml
    End point type
    Primary
    End point timeframe
    At six months post-transplantation after starting the study treatment in the 7 days post-transplantation.
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    41 [1]
    43 [2]
    Units: subjects
        iPTH>110 pg/ml
    9
    16
        iPTH<=110 pg/ml
    32
    27
    Notes
    [1] - 5 missing data
    [2] - 4 missing data
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1263
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Change in serum iPTH concentration

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    End point title
    		 Change in serum iPTH concentration
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months post-transplantation and 6 months of treatment in each study group
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    41
    43
    Units: pg/ml
        arithmetic mean (confidence interval 95%)
    -275.1 (-318.4 to -231.8)
    -212.6 (-249.8 to -175.4)
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0174
    Method
    		 ANOVA
    Confidence interval

    Secondary: iPTH≥30% reduction

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    End point title
    		 iPTH≥30% reduction
    End point description
    Percentage of patients with at least iPTH ≥ 30% reduction with respect to baseline, throughout the study
    End point type
    Secondary
    End point timeframe
    At six months post-transplantation after starting the study treatment in the 7 days post-transplantation
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    46
    47
    Units: subjects
        iPTH>=30% reduction
    43
    46
        iPTH<30% reduction
    3
    1
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3613
    Method
    		 Fisher exact
    Confidence interval

    Secondary: iPTH levels between 70-110 pg/ml

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    End point title
    		 iPTH levels between 70-110 pg/ml
    End point description
    End point type
    Secondary
    End point timeframe
    At six months post-transplantation after starting the study treatment in the 7 days post-transplantation
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    41
    43
    Units: subjects
        iPTH<70 pg/ml
    26
    16
        iPTH entre 70-110 pg/ml
    6
    11
        iPTH>=110 pg/ml
    9
    16
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Calcifediol v Paricalcitol
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0559
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Presence of calcifications

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    End point title
    		 Presence of calcifications
    End point description
    Percentage of patients with presence of calcifications on protocol renal biopsies at 6 months after treatment in each study group
    End point type
    Secondary
    End point timeframe
    At 6 months after treatment
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    17
    19
    Units: subjects
        Yes
    1
    0
        No
    16
    19
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4722
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Combined event

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    End point title
    		 Combined event
    End point description
    Incidence of at least of the following events: acute rejection, biopsy-proven acute rejection (BPAR) and/or subclinical rejection (ScR) and/or chronic damage (IFTA).
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    26
    21
    Units: subjects
    14
    6
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Calcifediol v Paricalcitol
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0814
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Osteocalcin

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    End point title
    		 Osteocalcin
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months post-transplantation and of treatment in each study group
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    42
    41
    Units: ng/mL
        arithmetic mean (confidence interval 95%)
    -7.13 (-10.0 to -4.2)
    -7.81 (-10.5 to -5.1)
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.391
    Method
    		 ANOVA
    Confidence interval

    Secondary: Alkaline phosphatase

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    End point title
    		 Alkaline phosphatase
    End point description
    End point type
    Secondary
    End point timeframe
    At 6 months post-transplantation
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    42
    42
    Units: μg/L
        arithmetic mean (confidence interval 95%)
    -1.90 (-5.1 to 1.3)
    -2.68 (-5.1 to -0.3)
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1811
    Method
    		 ANOVA
    Confidence interval

    Secondary: FGF-23

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    End point title
    		 FGF-23
    End point description
    End point type
    Secondary
    End point timeframe
    at 6 months post-transplantation
    End point values
    		 Paricalcitol Calcifediol
    Number of subjects analysed
    42
    42
    Units: pg/ml
        arithmetic mean (confidence interval 95%)
    -633.5 (-3200 to 1933)
    -1712 (-2944 to -481)
    Statistical analysis title
    		 Differences between groups
    Comparison groups
    Paricalcitol v Calcifediol
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2494
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Paricalcitol
    Reporting group description
    		 Paricalcitol oral, 1 µg/day (Zemplar®, Abbvie Inc. North Chicago, Illinois, USA), plus the standard treatment for a renal transplant recipient. The starting dose of paricalcitol was 1 µg/day, but this dose was adjusted based on the serum iPTH and Ca* levels

    Reporting group title
    Calcifediol
    Reporting group description
    		 Calcifediol oral (Hidroferol®, FAES FARMA, Spain), plus the standard treatment for a renal transplant recipient. The starting dose was 5 drops (20 µg or 1200 IU) and the maintenance dose was adjusted based on the 25(OH)D levels.

    Serious adverse events
    		 Paricalcitol Calcifediol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 46 (52.17%)
    20 / 47 (42.55%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Carcinoma transitional cell
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Removal of renal transplant
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele marsupialisation
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Administration site extravasation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 46 (4.35%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism lung
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Pseudomonas test positive
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cicatrix skin
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric collection
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    7 / 46 (15.22%)
    3 / 47 (6.38%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dilatation ureteral
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 46 (0.00%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cytomegalovirus colitis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 46 (10.87%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BK virus infection
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 46 (4.35%)
    2 / 47 (4.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 47 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 46 (2.17%)
    1 / 47 (2.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 47 (2.13%)
         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: 5%
    Non-serious adverse events
    		 Paricalcitol Calcifediol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 46 (89.13%)
    38 / 47 (80.85%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 46 (15.22%)
    1 / 47 (2.13%)
         occurrences all number
    7
    1
    Leucocitosis
         subjects affected / exposed
    5 / 46 (10.87%)
    3 / 47 (6.38%)
         occurrences all number
    5
    3
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    3 / 46 (6.52%)
    2 / 47 (4.26%)
         occurrences all number
    5
    2
    Oedema peripheral
         subjects affected / exposed
    3 / 46 (6.52%)
    4 / 47 (8.51%)
         occurrences all number
    4
    5
    Pyrexia
         subjects affected / exposed
    4 / 46 (8.70%)
    2 / 47 (4.26%)
         occurrences all number
    5
    2
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 46 (15.22%)
    4 / 47 (8.51%)
         occurrences all number
    7
    4
    Constipation
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    1 / 46 (2.17%)
    3 / 47 (6.38%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Renal disorder
         subjects affected / exposed
    9 / 46 (19.57%)
    5 / 47 (10.64%)
         occurrences all number
    11
    6
    Haematuria
         subjects affected / exposed
    2 / 46 (4.35%)
    3 / 47 (6.38%)
         occurrences all number
    3
    4
    Proteinuria
         subjects affected / exposed
    0 / 46 (0.00%)
    3 / 47 (6.38%)
         occurrences all number
    0
    4
    Renal tubular necrosis
         subjects affected / exposed
    3 / 46 (6.52%)
    1 / 47 (2.13%)
         occurrences all number
    3
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    16 / 46 (34.78%)
    6 / 47 (12.77%)
         occurrences all number
    22
    7
    Cytomegalovirus infection
         subjects affected / exposed
    4 / 46 (8.70%)
    4 / 47 (8.51%)
         occurrences all number
    4
    4
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 46 (6.52%)
    4 / 47 (8.51%)
         occurrences all number
    3
    4
    Hyperglycaemia
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 47 (0.00%)
         occurrences all number
    3
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2014
    - Regarding the modification of inclusion criteria # 3: Studies published last year with a similar objective on the effect of paricalcitol on PTH in transplant patients (Amer et al. Am J Trasplant 2013; Pérez et al. Eur J Pharmacol 2013 ) measured the effect of the drug on patients with any grade of HPTS (PTH> 65 pg / mL and medians around 100 pg / mL, respectively). In addition, the SEN guidelines (current 2011) recommend the treatment of PTH of the renal patient from plasma values ​​above 70 pg / mL (filtered below 60 mL / min, stage 3) and above 110 pg / mL (filtered below 30 mL / min, stage 4) we consider it sufficient for the patient to have PTH levels above 110 pg / mL to be included in the study. In this way, the degree of HPTS to be treated is extended, being more similar to the usual clinical practice. - The number of tubes to be extracted has been clarified, since finally a smaller blood sample was needed to perform the corresponding analyzes

    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
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