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    Clinical Trial Results:
    A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients

    Summary
    EudraCT number
    		 2014-004101-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    11 Nov 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jun 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0468E-102362
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00478608
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1741076
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    ClinicalTrials.gov_Inquiries@pfizer.com , Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    ClinicalTrials.gov_Inquiries@pfizer.com , Pfizer Inc, 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Mar 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 79
    Worldwide total number of subjects
    79
    EEA total number of subjects
    0
    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)
    22
    Adults (18-64 years)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited in Korea from March 2007 to November 2007.

    Pre-assignment
    Screening details
    		 Subjects were screened up to 7 days.

    Period 1
    Period 1 title
    Overall Study (Overall Period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Sirolimus (SRL)
    Arm description
    		 Subjects initially received SRL, Cyclosporine (CsA) and Corticosteroids (CS). 2-4 months following transplantation (trans), CsA was progressively withdrawn. On Day 1 (within 48 hours after trans) SRL was initiated (6 milligram (mg) loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2 milligram per day (mg/day), with adjustment to maintain a target trough blood level of 5-15 nanogram per millilitre (ng/ml). During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after trans at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. 2-4 months after trans, CsA was withdrawn over 4-8 weeks. CS were initiated within 24 hours before or after trans and tapered to greater than or equal to (≥) 5 mg/day of prednisone by the end of week 13. W/d of cs was prohibited.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SRL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SRL was administered at a loading dose of 6 mg on day 1, 2 mg on day 2 and adjusted to trough level of 5-15 ng/mL.

    Investigational medicinal product name
    CSA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    On month one CsA dose was adjusted to attain trough level of 200 - 400 ng/mL. From month one to CsA withdrawal the CsA dose was adjusted to attain trough level of 150 - 300 ng/mL.

    Investigational medicinal product name
    Corticosteroids
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Corticosteroids was administered at a dose of 5 mg once daily.

    Number of subjects in period 1
    		Sirolimus (SRL)
    Started
    79
    Completed
    59
    Not completed
    20
         Adverse Event
    15
         'Protocol Violation '
    3
         'Withdrawal by Subject '
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sirolimus (SRL)
    Reporting group description
    		 Subjects initially received SRL, Cyclosporine (CsA) and Corticosteroids (CS). 2-4 months following transplantation (trans), CsA was progressively withdrawn. On Day 1 (within 48 hours after trans) SRL was initiated (6 milligram (mg) loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2 milligram per day (mg/day), with adjustment to maintain a target trough blood level of 5-15 nanogram per millilitre (ng/ml). During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after trans at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. 2-4 months after trans, CsA was withdrawn over 4-8 weeks. CS were initiated within 24 hours before or after trans and tapered to greater than or equal to (≥) 5 mg/day of prednisone by the end of week 13. W/d of cs was prohibited.

    Reporting group values
    		 Sirolimus (SRL) Total
    Number of subjects
    		 79 79
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.16 ( 12.69 ) -
    Gender categorical
    Units: Subjects
        Female
    		 47 47
        Male
    		 32 32

    End points

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    End points reporting groups
    Reporting group title
    Sirolimus (SRL)
    Reporting group description
    		 Subjects initially received SRL, Cyclosporine (CsA) and Corticosteroids (CS). 2-4 months following transplantation (trans), CsA was progressively withdrawn. On Day 1 (within 48 hours after trans) SRL was initiated (6 milligram (mg) loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2 milligram per day (mg/day), with adjustment to maintain a target trough blood level of 5-15 nanogram per millilitre (ng/ml). During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after trans at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. 2-4 months after trans, CsA was withdrawn over 4-8 weeks. CS were initiated within 24 hours before or after trans and tapered to greater than or equal to (≥) 5 mg/day of prednisone by the end of week 13. W/d of cs was prohibited.

    Primary: Number of Subjects Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation

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    End point title
    		 Number of Subjects Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation [1]
    End point description
    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments example (e.g.), cell types and distributions. Subjects who received at least one dosing of SRL after transplantation. Subjects who received at least one dosing of SRL after transplantation.
    End point type
    Primary
    End point timeframe
    6 months after transplantation
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this outcome measure.
    End point values
    		 Sirolimus (SRL)
    Number of subjects analysed
    79
    Units: subjects
    12
    No statistical analyses for this end point

    Secondary: Glomerular Filtration Rate (GFR) (Nankivell Method)

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    End point title
    		 Glomerular Filtration Rate (GFR) (Nankivell Method)
    End point description
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure. Subjects who received at least one dose of SRL after transplantation. Observed values.
    End point type
    Secondary
    End point timeframe
    6 and 12 months
    End point values
    		 Sirolimus (SRL)
    Number of subjects analysed
    79
    Units: millilitre (mL)
    arithmetic mean (standard deviation)
        6 months
    67.36 ( 15.25 )
        12 months
    71.92 ( 18.82 )
    No statistical analyses for this end point

    Secondary: Serum Creatinine (On-Therapy Analysis)

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    End point title
    		 Serum Creatinine (On-Therapy Analysis)
    End point description
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly subjects typically have smaller muscle mass. Subjects who received at least one dose of SRL after transplantation.
    End point type
    Secondary
    End point timeframe
    Observed values Baseline, 6 and 12 months
    End point values
    		 Sirolimus (SRL)
    Number of subjects analysed
    79
    Units: mL/min
    arithmetic mean (standard deviation)
        Baseline
    9.42 ( 3.64 )
        6 months
    1.3 ( 0.36 )
        12 months
    1.25 ( 0.43 )
    No statistical analyses for this end point

    Secondary: Subject and Graft Survival

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    End point title
    		 Subject and Graft Survival
    End point description
    Subject survival defined as subjects living with or without a functioning graft. Graft survival defined as those subjects who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for > 8 weeks), retransplant or death during the first 12 months after randomization. Subjects who received at least one dosing of SRL after transplantation. Patients who received at least one dosing of SRL after transplantation.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Sirolimus (SRL)
    Number of subjects analysed
    79
    Units: subjects
        Subject survival 6 months
    77
        Subject survival 12 months
    76
        Graft survival 6 months
    77
        Graft survival 12 months
    76
    No statistical analyses for this end point

    Secondary: Number of Subjects Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation

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    End point title
    		 Number of Subjects Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation
    End point description
    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Subjects who received at least one dosing of SRL after transplantation. Subjects who received at least one dosing of SRL after transplantation.
    End point type
    Secondary
    End point timeframe
    12 months after transplantation
    End point values
    		 Sirolimus (SRL)
    Number of subjects analysed
    79
    Units: subjects
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored through one month following discontinuation of SRL
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Sirolimus (SRL)
    Reporting group description
    		 Subjects initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn. On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml. CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks. Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.

    Serious adverse events
    		 Sirolimus (SRL)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 79 (49.37%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Lymphocele
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences causally related to treatment / all
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Death (unknown cause)
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory arrest
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Asphyxia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    10 / 79 (12.66%)
         occurrences causally related to treatment / all
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences causally related to treatment / all
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fungal infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sirolimus (SRL)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    79 / 79 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    7
    Lymphocele
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    9
    Chest discomfort
         subjects affected / exposed
    7 / 79 (8.86%)
         occurrences all number
    7
    Oedema peripheral
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    6
    Generalised oedema
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Oedema
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Pitting oedema
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Face oedema
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Chest pain
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Catheter site pain
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Mass
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Swelling
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Sense of oppression
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Xerosis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Erectile dysfunction
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Genital haemorrhage
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dysmenorrhoea
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Amenorrhoea
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    9
    Rhinorrhoea
         subjects affected / exposed
    7 / 79 (8.86%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    7
    Productive cough
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Pharyngolaryngeal pain
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Rhinitis allergic
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hiccups
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    12 / 79 (15.19%)
         occurrences all number
    12
    Sleep disorder
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    29 / 79 (36.71%)
         occurrences all number
    31
    Alanine aminotransferase increased
         subjects affected / exposed
    17 / 79 (21.52%)
         occurrences all number
    18
    Aspartate aminotransferase increased
         subjects affected / exposed
    12 / 79 (15.19%)
         occurrences all number
    15
    Urine output decreased
         subjects affected / exposed
    11 / 79 (13.92%)
         occurrences all number
    12
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    10 / 79 (12.66%)
         occurrences all number
    10
    Blood creatinine increased
         subjects affected / exposed
    9 / 79 (11.39%)
         occurrences all number
    11
    Hepatic enzyme increased
         subjects affected / exposed
    9 / 79 (11.39%)
         occurrences all number
    9
    Blood triglycerides increased
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    8
    Blood glucose increased
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    8
    Weight increased
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Blood pressure increased
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    4
    Blood phosphorus decreased
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Haemoglobin decreased
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Blood albumin decreased
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Blood potassium increased
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Blood uric acid increased
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Body temperature increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Blood calcium decreased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Blood calcium increased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    24 / 79 (30.38%)
         occurrences all number
    26
    Post procedural complication
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Postoperative wound complication
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Femur fracture
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Palpitations
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Myocardial infarction
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Angina pectoris
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 79 (18.99%)
         occurrences all number
    16
    Convulsion
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dysarthria
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Migrane
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Somnolence
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    neuralgia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    19 / 79 (24.05%)
         occurrences all number
    19
    Leukopenia
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Ear pain
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Eye disorders
    Visual disturbance
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Vision blurred
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Xerophthalmia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dry eye
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Eyelid oedema
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Conjunctival oedema
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    31 / 79 (39.24%)
         occurrences all number
    36
    Diarrhoea
         subjects affected / exposed
    21 / 79 (26.58%)
         occurrences all number
    27
    Nausea
         subjects affected / exposed
    16 / 79 (20.25%)
         occurrences all number
    16
    Mouth ulceration
         subjects affected / exposed
    14 / 79 (17.72%)
         occurrences all number
    15
    Vomiting
         subjects affected / exposed
    13 / 79 (16.46%)
         occurrences all number
    13
    Abdominal pain
         subjects affected / exposed
    12 / 79 (15.19%)
         occurrences all number
    12
    Dyspepsia
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    8
    Abdominal pain upper
         subjects affected / exposed
    7 / 79 (8.86%)
         occurrences all number
    7
    Abdominal discomfort
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    6
    Stomatitis
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Abdominal distension
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    4
    Gingival hyperplasia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Epigastric discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Haematemesis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Oral disorder
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Oral discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Faecal incontinence
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dental caries
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Anorectal disorder
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    3
    Hepatotoxicity
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    18 / 79 (22.78%)
         occurrences all number
    20
    Pruritus
         subjects affected / exposed
    10 / 79 (12.66%)
         occurrences all number
    11
    Rash
         subjects affected / exposed
    7 / 79 (8.86%)
         occurrences all number
    8
    Hirsutism
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Rash papular
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    2
    Ecchymosis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    2
    Periorbital oedema
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Neurodermatitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Skin disorder
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dermal cyst
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Dermatitis acneiform
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Rash macular
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Blister
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Toxic skin eruption
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Swelling face
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    7 / 79 (8.86%)
         occurrences all number
    7
    Proteinuria
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Azotaemia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Albuminuria
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Renal tubular necrosis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Cushingoid
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    11 / 79 (13.92%)
         occurrences all number
    11
    Arthralgia
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    6
    Musculoskeletal pain
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    3 / 79 (3.80%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Osteoporosis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Neck pain
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Coccydynia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Arthritis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    26 / 79 (32.91%)
         occurrences all number
    43
    Nasopharyngitis
         subjects affected / exposed
    12 / 79 (15.19%)
         occurrences all number
    18
    Urinary tract infection
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    7
    Herpes zoster
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    6
    Herpes simplex
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    5
    Rhinitis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Oral candidiasis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Tinea versicolour
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Tinea pedis
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Varicella
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Vaginal infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Tinea cruris
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Bacteraemia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    BK virus infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Rash pustular
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gingival infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Fungal infection
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Orchitis
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    19 / 79 (24.05%)
         occurrences all number
    19
    Hyperlipidaemia
         subjects affected / exposed
    12 / 79 (15.19%)
         occurrences all number
    12
    Hyperkalaemia
         subjects affected / exposed
    8 / 79 (10.13%)
         occurrences all number
    8
    Hypokalaemia
         subjects affected / exposed
    6 / 79 (7.59%)
         occurrences all number
    7
    Hypoalbuminaemia
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Hyperglycaemia
         subjects affected / exposed
    5 / 79 (6.33%)
         occurrences all number
    5
    Diabetes mellitus
         subjects affected / exposed
    4 / 79 (5.06%)
         occurrences all number
    4
    Hypophosphataemia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Hyponatraemia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Hypoglycaemia
         subjects affected / exposed
    2 / 79 (2.53%)
         occurrences all number
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Electrolyte imbalance
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Anorexia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1
    Hyperamylasaemia
         subjects affected / exposed
    1 / 79 (1.27%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Apr 2007
    1. If the screening/baseline laboratory assessments were performed as routine examinations of the study site before the informed consent was obtained, the results of those assessment that were performed in 7 days prior to the transplantation could be acceptable. 2. A change in the timing of measurement of SRL and CsA trough whole-blood concentrations was made, detailed contents for AE assessment and management were added.
    17 Dec 2007
    Immune inhibition is tend to be more stabilized at 6 months after transplantation than an early stage of transplantation, therefore, SRL trough level should be maintained 15-30 ng/ml at 6months and 12-24 ng/ml at 7-12 months after transplantation.

    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
    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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