Clinical trial NCT02555787: Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
Official title: Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: FK506E
Tacrolimus
Observational
Kidney transplantation
Advagraf
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 4430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplant recipients

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.

Detailed description: This is a multicenter long-term (up to five years post-conversion), non-interventional registry in kidney transplant patients who have been converted from tacrolimus BD to Advagraf. Centers that are providing medical care for kidney transplant patients who may convert patients from tacrolimus BD to Advagraf will be identified and requested to approach patients for consent to participate.

Eligibility criteria: 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.

Exclusion Criteria:

* Patients currently taking Advagraf treatment

Primary outcomes:
measure: Change in renal function as measured by eGFR using the MDRD-4 formula
timeFrame: 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 outcomes:
measure: Change in renal function as measured by eGFR using the CKD-Epi formula
timeFrame: 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)
measure: Overall patient survival
timeFrame: From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
measure: Overall graft survival (time to graft loss)
timeFrame: From transplantation to date of graft loss
measure: DSA status (de novo)
timeFrame: From transplantation to EOS (up to 5 years post conversion)
measure: Incidence of BPAR episodes
timeFrame: From transplantation to EOS (up to 5 years post conversion)
measure: Time to first incidence of BPAR episodes
timeFrame: From transplantation to EOS (up to 5 years post conversion)
measure: Advagraf dose
timeFrame: From transplantation to EOS (up to 5 years post conversion)
measure: Tacrolimus trough level
timeFrame: From transplantation to EOS (up to 5 years post conversion)
measure: Current immunosuppressant regimen
timeFrame: From transplantation to EOS (up to 5 years post conversion)
measure: Status of treatment with Advagraf
timeFrame: From transplantation to EOS (up to 5 years post conversion)
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Site AU6107
state: New South Wales
city: Gosford
country: Australia
facility: Site AU6106
state: New South Wales
city: New Lambton
country: Australia
facility: Site AU6104
state: New South Wales
city: Westmead
country: Australia
facility: Site AU6103
state: New South Wales
city: Harvey Bay
country: Australia
facility: Site AU6111
state: Queensland
city: North Adelaide
country: Australia
facility: Site AU6108
state: South Australia
city: Nedlands
country: Australia
facility: Site AU6110
state: Western Australia
city: Perth
country: Australia
facility: Site AU6105
state: Western Australia
city: Linz
country: Austria
facility: Site AT4304
state: Oberösterreich
city: Graz
country: Austria
facility: Site AT4301
state: Steiermark
city: Innsbruck
country: Austria
facility: Site AT4302
state: Tirol
city: Innsbruck
country: Austria
facility: Site AT4303
state: Tirol
city: Leuven
country: Belgium
facility: Site BE3201
state: Vlaams Brabant
city: Vancouver
country: Canada
facility: Site CA1001
state: British Columbia
city: Olomouc
country: Czechia
facility: Site CZ4202
city: Nice
country: France
facility: Site FR3310
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: Site FR3318
state: Alsace
city: Marseille Cedex 5
country: France
facility: Site FR3315
state: Bouches-du-Rhône
city: Caen
country: France
facility: Site FR3303
state: Calvados
city: Besancon Cedex
country: France
facility: Site FR3306
state: Doubs
city: Brest
country: France
facility: Site FR3311
state: Finistère
city: Bordeaux
country: France
facility: Site FR3302
state: Gironde
city: Toulouse
country: France
facility: Site FR3313
state: Haute-Garonne
city: ROUEN cedex
country: France
facility: Site FR3307
state: Haute-Normandie
city: Limoges
country: France
facility: Site FR3321
state: Hautte-Vienne
city: Rennes Cedex
country: France
facility: Site FR3317
state: Ille-et-Vilaine
city: Tours
country: France
facility: Site FR3305
state: Indre-et-Loire
city: Nantes
country: France
facility: Site FR3312
state: Loire-Atlantique
city: Saint-Etienne Cedex 2
country: France
facility: Site FR3309
state: Loire
city: Angers
country: France
facility: Site FR3314
state: Maine-et-Loire
city: Lille
country: France
facility: Site FR3325
state: Nord
city: Amiens Cedex 1
country: France
facility: Site FR3308
state: Picardie
city: Clermont Ferrand Cedex 1
country: France
facility: Site FR3319
state: Puy-de-Dôme
city: Lyon Cedex 03
country: France
facility: Site FR3324
state: Rhône-Alpes
city: POITIERS cedex
country: France
facility: Site FR3322
state: Vienne
city: Paris
country: France
facility: Site FR3323
city: Creteil
country: France
facility: Site FR3301
state: Île-de-France
city: Le Kremlin Bicetre Cedex
country: France
facility: Site FR3316
state: Île-de-France
city: Mannheim
country: Germany
facility: Site DE4902
state: Baden-Württemberg
city: Wuerzburg
country: Germany
facility: Site DE4901
state: Bayern
city: Hannover
country: Germany
facility: Site DE4903
state: Niedersachsen
city: Athens
country: Greece
facility: Site GR3002
city: Athens
country: Greece
facility: Site GR3004
city: Hong Kong
country: Hong Kong
facility: Site HK8201
city: Hong Kong
country: Hong Kong
facility: Site HK8521
city: Debrecen
country: Hungary
facility: Site HU3601
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Site HU3602
city: Napoli
country: Italy
facility: Site IT3903
state: Campania
city: Verona
country: Italy
facility: Site IT3907
state: Veneto
city: Bari
country: Italy
facility: Site IT3905
city: Bologna
country: Italy
facility: Site IT3902
city: Bolzano
country: Italy
facility: Site IT3914
city: Genova
country: Italy
facility: Site IT3901
city: L'Aquila
country: Italy
facility: Site IT3904
city: Novara
country: Italy
facility: Site IT3911
city: Novara
country: Italy
facility: Site IT3916
city: Padova
country: Italy
facility: Site IT3910
city: Perugia
country: Italy
facility: Site IT3909
city: Salerno
country: Italy
facility: Site IT3912
city: Salerno
country: Italy
facility: Site IT39013
city: Salerno
country: Italy
facility: Site IT3913
city: Sassari
country: Italy
facility: Site IT3908
city: Udine
country: Italy
facility: Site IT3915
city: Venezia
country: Italy
facility: Site IT3906
city: Nagoya-shi
country: Japan
facility: Site JP8108
state: Aiti
city: Toyoake
country: Japan
facility: Site JP8109
state: Aiti
city: Nishinomiya
country: Japan
facility: Site JP8110
state: Hyôgo
city: Nishinomiya
country: Japan
facility: Site JP8111
state: Hyôgo
city: Kawasaki-shi
country: Japan
facility: Site JP8106
state: Kanagawa
city: Chiba
country: Japan
facility: Site JP8107
state: Tiba
city: Ota-ku
country: Japan
facility: Site JP8105
state: Tôkyô
city: Shinjuku-Ku
country: Japan
facility: Site JP8104
state: Tôkyô
city: Akita
country: Japan
facility: Site JP8101
city: Niigata
country: Japan
facility: Site JP8102
city: Busan
country: Korea, Republic of
facility: Site KR8214
state: Busan Gwang'yeogsi [Pusan-Kwan
city: Busan
country: Korea, Republic of
facility: Site KR8205
state: Busan Gwang'yeogsi [Pusan-Kwan
city: Pusan
country: Korea, Republic of
facility: Site KR8203
state: Busan Gwang'yeogsi [Pusan-Kwan
city: Daegu
country: Korea, Republic of
facility: Site KR8202
state: Daegu Gwang'yeogsi [Taegu-Kwan
city: Daegu
country: Korea, Republic of
facility: Site KR8219
state: Daegu Gwang'yeogsi
city: Daejeon
country: Korea, Republic of
facility: Site KR8207
state: Daejeon Gwang'yeogsi [Taejon-K
city: Gwangju
country: Korea, Republic of
facility: Site KR8212
state: Gwangju Gwang'yeogsi
city: Suwon
country: Korea, Republic of
facility: Site KR8218
state: Gyeonggido [Kyonggi-do]
city: Bucheon-city
country: Korea, Republic of
facility: Site KR8216
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Site KR8201
state: Incheon Gwang'yeogsi [Inch'n-K
city: Seoul
country: Korea, Republic of
facility: Site KR8211
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Site KR8210
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Site KR8206
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Site KR8209
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Site KR8204
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Site KR8208
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Seoul
country: Korea, Republic of
facility: Site KR8213
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Ulsan
country: Korea, Republic of
facility: Site KR8215
state: Ulsan Gwang'yeogsi [Ulsan-Kwan
city: Kuala Lumpur
country: Malaysia
facility: Site MY6001
state: Wilayah Persekutuan Kuala Lump
city: Nijmegen
country: Netherlands
facility: Site NL3103
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Site NL3104
state: Noord-Holland
city: Groningen
country: Netherlands
facility: Site NL3105
city: Utrecht
country: Netherlands
facility: Site NL3101
city: Quezon City
country: Philippines
facility: Site PH6303
state: National Capital Region
city: Lublin
country: Poland
facility: Site PL4808
state: Lubelskie
city: Warszawa
country: Poland
facility: Site PL4801
state: Mazowieckie
city: Poznan
country: Poland
facility: Site PL4806
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Site PL4807
state: Zachodniopomorskie
city: Porto
country: Portugal
facility: Site PT3511
city: Cluj-Napoca;
country: Romania
facility: Site RO4004
state: Cluj
city: Bucuresti
country: Romania
facility: Site RO4001
city: Bucuresti
country: Romania
facility: Site RO4002
city: Bucuresti
country: Romania
facility: Site RO4003
city: Niš
country: Serbia
facility: Site SB3804
state: Nišavski Okrug
city: Belgrade
country: Serbia
facility: Site SB3801
city: Belgrade
country: Serbia
facility: Site SB3802
city: Novi Sad
country: Serbia
facility: Site SB3803
city: Santiago de Compostela
country: Spain
facility: Site ES3410
state: A Coruña
city: Barcelona
country: Spain
facility: Site ES3401
city: Barcelona
country: Spain
facility: Site ES3403
city: Kaohsiung City
country: Taiwan
facility: Site TW8862
state: Kaohsiung
city: Taichung
country: Taiwan
facility: Site TW8863
state: Taichung Municipality
city: Tainan
country: Taiwan
facility: Site TW8861
city: Bangkok
country: Thailand
facility: Site TH6601
state: Krung Thep Maha Nakhon [Bangko
city: Bangkok
country: Thailand
facility: Site TH6602
state: Krung Thep Maha Nakhon [Bangko
city: Khon Kaen
country: Thailand
facility: Site TH6603
city: Peterborough
country: United Kingdom
facility: Site GB4403
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: Site GB4405
state: Devon
city: Manchester
country: United Kingdom
facility: Site GB4406
state: Lancashire
city: Ipswich
country: United Kingdom
facility: Site GB4407
state: Suffolk
city: Leeds
country: United Kingdom
facility: Site GB4401
city: Liverpool
country: United Kingdom
facility: Site GB4402
city: London
country: United Kingdom
facility: Site GB4408
city: Ha Noi
country: Vietnam
facility: Site VN8401
state: Ha Noi, Thanh Pho
city: Ho Chi Minh
country: Vietnam
facility: Site VN8402
state: Ho Chi Minh, Thanh Pho
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Medical Affairs Europe
role: STUDY_DIRECTOR
References: