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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02555787
Ethics application status
Date submitted
18/09/2015
Date registered
22/09/2015
Date last updated
20/05/2021

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 - Estimated Glomerular Filtration Rate (eGFR), Modification Diet in Renal Disease (MDRD-4), End of Study (EOS)
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 - Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)
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 - Patients who are lost to follow up or alive at EOS - or at time of analysis will be censored
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) - Defined as time from transplantation to graft loss. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at the time of discontinuation of the patient from the study. The date of graft loss is the earliest date of any of these events. In case of dialysis as reason for graft loss, the date of graft loss is the first day of the last ongoing dialysis period reported
Timepoint [3] 0 0
From transplantation to date of graft loss
Secondary outcome [4] 0 0
DSA status (de novo) - Donor Specific Antibody (DSA). Laboratory assessment performed where possible in accordance with standard of care
Timepoint [4] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [5] 0 0
Incidence of BPAR episodes - Biopsy Proven Acute Rejection (BPAR). Severity by Banff classification (International standardisation of criteria for histological diagnosis of allograft rejection), treated and untreated, and steroid sensitive or resistant
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 - Severity by Banff classification, treated and untreated, and steroid sensitive or resistant
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 - Dose and formulation (additional to or instead of Advagraf)
Timepoint [9] 0 0
From transplantation to EOS (up to 5 years post conversion)
Secondary outcome [10] 0 0
Status of treatment with Advagraf - Patients who discontinued Advagraf treatment will be retained in the registry for data on long-term outcomes provided consent is not withdrawn. The reasons associated with the discontinuation will be recorded
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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
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Italy
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Bolzano
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Italy
State/province [41] 0 0
Genova
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Italy
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L'Aquila
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Italy
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Novara
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Italy
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Padova
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Italy
State/province [45] 0 0
Perugia
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Italy
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Salerno
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Italy
State/province [47] 0 0
Sassari
Country [48] 0 0
Italy
State/province [48] 0 0
Udine
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Italy
State/province [49] 0 0
Venezia
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Japan
State/province [50] 0 0
Aiti
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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
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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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Netherlands
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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
State/province [74] 0 0
Mazowieckie
Country [75] 0 0
Poland
State/province [75] 0 0
Wielkopolskie
Country [76] 0 0
Poland
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Zachodniopomorskie
Country [77] 0 0
Portugal
State/province [77] 0 0
Porto
Country [78] 0 0
Romania
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Cluj
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Romania
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Bucuresti
Country [80] 0 0
Serbia
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NiĆĄavski 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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Spain
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A Coruña
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Spain
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Barcelona
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Taiwan
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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
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/show/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
Other publications