Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02118896
Registration number
NCT02118896
Ethics application status
Date submitted
17/04/2014
Date registered
21/04/2014
Titles & IDs
Public title
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
Query!
Scientific title
A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen
Query!
Secondary ID [1]
0
0
2005-005714-20
Query!
Secondary ID [2]
0
0
F506-CL-0857
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Transplantation
0
0
Query!
Liver Transplantation
0
0
Query!
Kidney Transplantation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - FK506E
Experimental: 1: FK506E (MR4) - Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective immunosuppression. MR4 capsules were taken orally, once daily in the morning. MR4 capsules were to be swallowed with fluid (preferably water) on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. MR4 was supplied as 0.5 mg, 1 mg and 5 mg capsules in amber glass bottles or in blister packs.
Treatment: Drugs: FK506E
oral
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Participant Survival
Query!
Assessment method [1]
0
0
Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood's formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
Query!
Timepoint [1]
0
0
Up to 5.5 years (66 months (phase II) and 24 months (phase III)).
Query!
Primary outcome [2]
0
0
Graft Survival
Query!
Assessment method [2]
0
0
Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood's formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
Query!
Timepoint [2]
0
0
Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).
Query!
Secondary outcome [1]
0
0
Biopsy-confirmed Acute Rejection (BCAR) Episodes
Query!
Assessment method [1]
0
0
FAS population. Evaluation of biopsy specimens performed by local histopathologist following "Histological Grading of Biopsies for Rejection" using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal.
Query!
Timepoint [1]
0
0
Up to 6 years.
Query!
Secondary outcome [2]
0
0
Time to First BCAR Episode
Query!
Assessment method [2]
0
0
The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.
Query!
Timepoint [2]
0
0
Up to 1344 days (3.75 years).
Query!
Secondary outcome [3]
0
0
Number of Participants With Adverse Events
Query!
Assessment method [3]
0
0
An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.
Query!
Timepoint [3]
0
0
From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).
Query!
Eligibility
Key inclusion criteria
* Patients who had already participated in the previous phase II pharmacokinetic or phase III studies with FK506E (MR4).
* Patients capable of understanding the purpose and risks of the study, who had been fully informed and given written informed consent to participate in the study.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Pregnant women or nursing mothers.
* Women unwilling or unable to use adequate contraception during the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
24/02/2003
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/10/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
850
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Brisbane
Query!
Recruitment hospital [3]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [4]
0
0
Royal Melbourne Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
4102 - Brisbane
Query!
Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
3050 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Ohio
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Innsbruck
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Wien
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Bruxelles
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Gent
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Leuven
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Liege
Query!
Country [8]
0
0
Brazil
Query!
State/province [8]
0
0
Campinas
Query!
Country [9]
0
0
Brazil
Query!
State/province [9]
0
0
Porto Alegre
Query!
Country [10]
0
0
Brazil
Query!
State/province [10]
0
0
Rio de Janeiro
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Alberta
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Canada
Query!
State/province [13]
0
0
Quebec
Query!
Country [14]
0
0
Canada
Query!
State/province [14]
0
0
Vancouver
Query!
Country [15]
0
0
Czechia
Query!
State/province [15]
0
0
Praha 4
Query!
Country [16]
0
0
Denmark
Query!
State/province [16]
0
0
Århus N
Query!
Country [17]
0
0
Finland
Query!
State/province [17]
0
0
Helsinki
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Bicetre Cedex
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Cedex 05
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Cedex 1
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Cedex 3
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Cedex 5
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Cedex 9
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Cedex
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Clichy
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Creteil
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Créteil
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Grenoble
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
St Etienne
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Strasbourg
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Villejuif
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Bad Oeynhausen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Berlin
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Bochum
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Erlangen
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Essen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Frankfurt/Main
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Halle
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Hamburg
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Hannover
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Heidelberg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Koeln
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Munchen
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Regensburg
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Budapest
Query!
Country [46]
0
0
Ireland
Query!
State/province [46]
0
0
Dublin
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Bergamo
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Bologna
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Genova
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Milano
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Modena
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Padova
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Palermo
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Roma
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Siena
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Udine
Query!
Country [57]
0
0
Mexico
Query!
State/province [57]
0
0
Morelos
Query!
Country [58]
0
0
Mexico
Query!
State/province [58]
0
0
Tlalpan
Query!
Country [59]
0
0
Netherlands
Query!
State/province [59]
0
0
Maastricht
Query!
Country [60]
0
0
New Zealand
Query!
State/province [60]
0
0
Auckland
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Bydgoszcz
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Szczecin
Query!
Country [63]
0
0
South Africa
Query!
State/province [63]
0
0
Cape Town
Query!
Country [64]
0
0
South Africa
Query!
State/province [64]
0
0
Durban
Query!
Country [65]
0
0
South Africa
Query!
State/province [65]
0
0
Pretoria
Query!
Country [66]
0
0
South Africa
Query!
State/province [66]
0
0
Tygerberg
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Vizcaya
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Barcelona
Query!
Country [69]
0
0
Spain
Query!
State/province [69]
0
0
Madrid
Query!
Country [70]
0
0
Spain
Query!
State/province [70]
0
0
Oviedo
Query!
Country [71]
0
0
Spain
Query!
State/province [71]
0
0
Pamplona
Query!
Country [72]
0
0
Spain
Query!
State/province [72]
0
0
Santiago de Compostela
Query!
Country [73]
0
0
Sweden
Query!
State/province [73]
0
0
Gothenburg
Query!
Country [74]
0
0
Sweden
Query!
State/province [74]
0
0
Stockholm
Query!
Country [75]
0
0
Switzerland
Query!
State/province [75]
0
0
Zurich
Query!
Country [76]
0
0
United Kingdom
Query!
State/province [76]
0
0
Coventry
Query!
Country [77]
0
0
United Kingdom
Query!
State/province [77]
0
0
Edgbaston
Query!
Country [78]
0
0
United Kingdom
Query!
State/province [78]
0
0
Glasgow
Query!
Country [79]
0
0
United Kingdom
Query!
State/province [79]
0
0
London
Query!
Country [80]
0
0
United Kingdom
Query!
State/province [80]
0
0
Manchester
Query!
Country [81]
0
0
United Kingdom
Query!
State/province [81]
0
0
Newcastle upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Astellas Pharma Europe Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02118896
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Central Contact
Query!
Address
0
0
Astellas Pharma Europe Ltd.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02118896