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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
Date last updated
31/10/2024

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
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France
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Finistère
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France
State/province [13] 0 0
Gironde
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France
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Haute-Garonne
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France
State/province [15] 0 0
Haute-Normandie
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France
State/province [16] 0 0
Hautte-Vienne
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France
State/province [17] 0 0
Ille-et-Vilaine
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France
State/province [18] 0 0
Indre-et-Loire
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France
State/province [19] 0 0
Loire-Atlantique
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France
State/province [20] 0 0
Loire
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France
State/province [21] 0 0
Maine-et-Loire
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France
State/province [22] 0 0
Nord
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France
State/province [23] 0 0
Picardie
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France
State/province [24] 0 0
Puy-de-Dôme
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France
State/province [25] 0 0
Rhône-Alpes
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France
State/province [26] 0 0
Vienne
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France
State/province [27] 0 0
Paris
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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
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Athens
Country [33] 0 0
Hong Kong
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Hong Kong
Country [34] 0 0
Hungary
State/province [34] 0 0
Hajdú-Bihar
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Hungary
State/province [35] 0 0
Budapest
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Italy
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Campania
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Italy
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Veneto
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Italy
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Bari
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Italy
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Bologna
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Italy
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Bolzano
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Italy
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Genova
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Italy
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L'Aquila
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Novara
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Padova
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Perugia
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Salerno
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Sassari
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Italy
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Udine
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Italy
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Venezia
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Japan
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Aiti
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Japan
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Hyôgo
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Japan
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Kanagawa
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Japan
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Tiba
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Japan
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Tôkyô
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Japan
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Akita
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Japan
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Niigata
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Korea, Republic of
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Busan Gwang'yeogsi [Pusan-Kwan
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Korea, Republic of
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Korea, Republic of
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Daegu Gwang'yeogsi
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Korea, Republic of
State/province [60] 0 0
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Korea, Republic of
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Gwangju Gwang'yeogsi
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Korea, Republic of
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Korea, Republic of
State/province [63] 0 0
Gyeonggido
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Korea, Republic of
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Korea, Republic of
State/province [65] 0 0
Seoul Teugbyeolsi [Seoul-T'ukp
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Korea, Republic of
State/province [66] 0 0
Ulsan Gwang'yeogsi [Ulsan-Kwan
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Malaysia
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Wilayah Persekutuan Kuala Lump
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Netherlands
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Netherlands
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Noord-Holland
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Netherlands
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Groningen
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Utrecht
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Philippines
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National Capital Region
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Poland
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Lubelskie
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Poland
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Mazowieckie
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Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
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Portugal
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Porto
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Romania
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Cluj
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Bucuresti
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Nišavski Okrug
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Serbia
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Belgrade
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Serbia
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Novi Sad
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A Coruña
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Barcelona
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Kaohsiung
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Taiwan
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Taichung Municipality
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Taiwan
State/province [87] 0 0
Tainan
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Thailand
State/province [88] 0 0
Krung Thep Maha Nakhon [Bangko
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Thailand
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Khon Kaen
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United Kingdom
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Cambridgeshire
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United Kingdom
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Devon
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United Kingdom
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Lancashire
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United Kingdom
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Suffolk
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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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
A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.
Trial website
https://clinicaltrials.gov/study/NCT02555787
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02555787