Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

Kidney Transplantation Clinical Trial

— CHORUS  

Official title:

Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555787
• Other study ID #: 506-MA-1002
• Status: Completed
• Start date: March 5, 2015
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4430
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Netherlands,  Philippines,  Poland,  Portugal,  Romania,  Serbia,  Spain,  Taiwan,  Thailand,  United Kingdom,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Change in renal function as measured by eGFR using the CKD-Epi formula	Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)	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	Overall patient survival	Patients who are lost to follow up or alive at EOS - or at time of analysis will be censored	From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
Secondary	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	From transplantation to date of graft loss
Secondary	DSA status (de novo)	Donor Specific Antibody (DSA). Laboratory assessment performed where possible in accordance with standard of care	From transplantation to EOS (up to 5 years post conversion)
Secondary	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	From transplantation to EOS (up to 5 years post conversion)
Secondary	Time to first incidence of BPAR episodes	Severity by Banff classification, treated and untreated, and steroid sensitive or resistant	From transplantation to EOS (up to 5 years post conversion)
Secondary	Advagraf dose		From transplantation to EOS (up to 5 years post conversion)
Secondary	Tacrolimus trough level		From transplantation to EOS (up to 5 years post conversion)
Secondary	Current immunosuppressant regimen	Dose and formulation (additional to or instead of Advagraf)	From transplantation to EOS (up to 5 years post conversion)
Secondary	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	From transplantation to EOS (up to 5 years post conversion)