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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02555787




Registration number
NCT02555787
Ethics application status
Date submitted
18/09/2015
Date registered
22/09/2015

Titles & IDs
Public title
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
Scientific title
Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
Secondary ID [1] 0 0
506-MA-1002
Universal Trial Number (UTN)
Trial acronym
CHORUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Tacrolimus

Patients converted from tacrolimus BD to Advagraf - Oral


Treatment: Drugs: Tacrolimus
oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in renal function as measured by eGFR using the MDRD-4 formula
Timepoint [1] 0 0
At transplantation, within 3 months after transplantation, up to 2 years pre-conversion and then every 6 months prior to conversion, at conversion (baseline), 12 months post-conversion and annually thereafter until EOS (up to 5 years post conversion)
Secondary outcome [1] 0 0
Change in renal function as measured by eGFR using the CKD-Epi formula
Timepoint [1] 0 0
At transplantation, within 3 months after transplantation, up to 2 years pre-conversion and then every 6 months prior to conversion, at conversion (baseline), 12 months post-conversion and annually thereafter until EOS (up to 5 years post conversion)
Secondary outcome [2] 0 0
Overall patient survival
Timepoint [2] 0 0
From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
Secondary outcome [3] 0 0
Overall graft survival (time to graft loss)
Timepoint [3] 0 0
From transplantation to date of graft loss
Secondary outcome [4] 0 0
DSA status (de novo)
Timepoint [4] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [5] 0 0
Incidence of BPAR episodes
Timepoint [5] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [6] 0 0
Time to first incidence of BPAR episodes
Timepoint [6] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [7] 0 0
Advagraf dose
Timepoint [7] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [8] 0 0
Tacrolimus trough level
Timepoint [8] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [9] 0 0
Current immunosuppressant regimen
Timepoint [9] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [10] 0 0
Status of treatment with Advagraf
Timepoint [10] 0 0
From transplantation to EOS (up to 5 years post conversion)

Eligibility
Key inclusion criteria
* Adult kidney transplant patients who are on tacrolimus BD and identified for conversion to Advagraf. Patients will only be approached about participating in the registry after their physician has made the decision to convert them to Advagraf. Patients previously treated with Advagraf and who have stopped for any reason will not be excluded from the registry provided that the physician has decided to convert.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients currently taking Advagraf treatment

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
Accrual to date
Final
4430
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Site AU6107 - Camperdown
Recruitment hospital [2] 0 0
Site AU6106 - Gosford
Recruitment hospital [3] 0 0
Site AU6104 - New Lambton
Recruitment hospital [4] 0 0
Site AU6103 - Westmead
Recruitment hospital [5] 0 0
Site AU6111 - Harvey Bay
Recruitment hospital [6] 0 0
Site AU6108 - North Adelaide
Recruitment hospital [7] 0 0
Site AU6110 - Nedlands
Recruitment hospital [8] 0 0
Site AU6105 - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4655 - Harvey Bay
Recruitment postcode(s) [6] 0 0
5000 - North Adelaide
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment postcode(s) [8] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Oberösterreich
Country [2] 0 0
Austria
State/province [2] 0 0
Steiermark
Country [3] 0 0
Austria
State/province [3] 0 0
Tirol
Country [4] 0 0
Belgium
State/province [4] 0 0
Vlaams Brabant
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Czechia
State/province [6] 0 0
Olomouc
Country [7] 0 0
France
State/province [7] 0 0
Alpes-Maritimes
Country [8] 0 0
France
State/province [8] 0 0
Alsace
Country [9] 0 0
France
State/province [9] 0 0
Bouches-du-Rhône
Country [10] 0 0
France
State/province [10] 0 0
Calvados
Country [11] 0 0
France
State/province [11] 0 0
Doubs
Country [12] 0 0
France
State/province [12] 0 0
Finistère
Country [13] 0 0
France
State/province [13] 0 0
Gironde
Country [14] 0 0
France
State/province [14] 0 0
Haute-Garonne
Country [15] 0 0
France
State/province [15] 0 0
Haute-Normandie
Country [16] 0 0
France
State/province [16] 0 0
Hautte-Vienne
Country [17] 0 0
France
State/province [17] 0 0
Ille-et-Vilaine
Country [18] 0 0
France
State/province [18] 0 0
Indre-et-Loire
Country [19] 0 0
France
State/province [19] 0 0
Loire-Atlantique
Country [20] 0 0
France
State/province [20] 0 0
Loire
Country [21] 0 0
France
State/province [21] 0 0
Maine-et-Loire
Country [22] 0 0
France
State/province [22] 0 0
Nord
Country [23] 0 0
France
State/province [23] 0 0
Picardie
Country [24] 0 0
France
State/province [24] 0 0
Puy-de-Dôme
Country [25] 0 0
France
State/province [25] 0 0
Rhône-Alpes
Country [26] 0 0
France
State/province [26] 0 0
Vienne
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Île-de-France
Country [29] 0 0
Germany
State/province [29] 0 0
Baden-Württemberg
Country [30] 0 0
Germany
State/province [30] 0 0
Bayern
Country [31] 0 0
Germany
State/province [31] 0 0
Niedersachsen
Country [32] 0 0
Greece
State/province [32] 0 0
Athens
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Hong Kong
Country [34] 0 0
Hungary
State/province [34] 0 0
Hajdú-Bihar
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Italy
State/province [36] 0 0
Campania
Country [37] 0 0
Italy
State/province [37] 0 0
Veneto
Country [38] 0 0
Italy
State/province [38] 0 0
Bari
Country [39] 0 0
Italy
State/province [39] 0 0
Bologna
Country [40] 0 0
Italy
State/province [40] 0 0
Bolzano
Country [41] 0 0
Italy
State/province [41] 0 0
Genova
Country [42] 0 0
Italy
State/province [42] 0 0
L'Aquila
Country [43] 0 0
Italy
State/province [43] 0 0
Novara
Country [44] 0 0
Italy
State/province [44] 0 0
Padova
Country [45] 0 0
Italy
State/province [45] 0 0
Perugia
Country [46] 0 0
Italy
State/province [46] 0 0
Salerno
Country [47] 0 0
Italy
State/province [47] 0 0
Sassari
Country [48] 0 0
Italy
State/province [48] 0 0
Udine
Country [49] 0 0
Italy
State/province [49] 0 0
Venezia
Country [50] 0 0
Japan
State/province [50] 0 0
Aiti
Country [51] 0 0
Japan
State/province [51] 0 0
Hyôgo
Country [52] 0 0
Japan
State/province [52] 0 0
Kanagawa
Country [53] 0 0
Japan
State/province [53] 0 0
Tiba
Country [54] 0 0
Japan
State/province [54] 0 0
Tôkyô
Country [55] 0 0
Japan
State/province [55] 0 0
Akita
Country [56] 0 0
Japan
State/province [56] 0 0
Niigata
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Busan Gwang'yeogsi [Pusan-Kwan
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Daegu Gwang'yeogsi [Taegu-Kwan
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Daegu Gwang'yeogsi
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Daejeon Gwang'yeogsi [Taejon-K
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Gwangju Gwang'yeogsi
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Gyeonggido [Kyonggi-do]
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Gyeonggido
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Incheon Gwang'yeogsi [Inch'n-K
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Seoul Teugbyeolsi [Seoul-T'ukp
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Ulsan Gwang'yeogsi [Ulsan-Kwan
Country [67] 0 0
Malaysia
State/province [67] 0 0
Wilayah Persekutuan Kuala Lump
Country [68] 0 0
Netherlands
State/province [68] 0 0
Gelderland
Country [69] 0 0
Netherlands
State/province [69] 0 0
Noord-Holland
Country [70] 0 0
Netherlands
State/province [70] 0 0
Groningen
Country [71] 0 0
Netherlands
State/province [71] 0 0
Utrecht
Country [72] 0 0
Philippines
State/province [72] 0 0
National Capital Region
Country [73] 0 0
Poland
State/province [73] 0 0
Lubelskie
Country [74] 0 0
Poland
State/province [74] 0 0
Mazowieckie
Country [75] 0 0
Poland
State/province [75] 0 0
Wielkopolskie
Country [76] 0 0
Poland
State/province [76] 0 0
Zachodniopomorskie
Country [77] 0 0
Portugal
State/province [77] 0 0
Porto
Country [78] 0 0
Romania
State/province [78] 0 0
Cluj
Country [79] 0 0
Romania
State/province [79] 0 0
Bucuresti
Country [80] 0 0
Serbia
State/province [80] 0 0
Nišavski Okrug
Country [81] 0 0
Serbia
State/province [81] 0 0
Belgrade
Country [82] 0 0
Serbia
State/province [82] 0 0
Novi Sad
Country [83] 0 0
Spain
State/province [83] 0 0
A Coruña
Country [84] 0 0
Spain
State/province [84] 0 0
Barcelona
Country [85] 0 0
Taiwan
State/province [85] 0 0
Kaohsiung
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taichung Municipality
Country [87] 0 0
Taiwan
State/province [87] 0 0
Tainan
Country [88] 0 0
Thailand
State/province [88] 0 0
Krung Thep Maha Nakhon [Bangko
Country [89] 0 0
Thailand
State/province [89] 0 0
Khon Kaen
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Cambridgeshire
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Devon
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Lancashire
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Suffolk
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Leeds
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Liverpool
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
Vietnam
State/province [97] 0 0
Ha Noi, Thanh Pho
Country [98] 0 0
Vietnam
State/province [98] 0 0
Ho Chi Minh, Thanh Pho

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Europe Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Affairs Europe
Address 0 0
Astellas Pharma Europe Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.


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 not provided in https://clinicaltrials.gov/study/NCT02555787