A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant

Kidney Transplant Clinical Trial

— ADDRESS  

Official title:

A Long-term Follow-up of Adult Kidney and Liver Allograft Recipients Previously Enrolled Into a Tacrolimus (Advagraf) Trial. A Multicentre Non-interventional Post Authorization Study (PAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057484
• Other study ID #: PMR-EC-1213
• Status: Completed
• Start date: March 3, 2014
• Est. completion date: October 17, 2017

Study information

• Verified date: December 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients. This study will also evaluate the overall long-term impact of Advagraf on kidney and liver allograft recipients.

Description:

Prograf is one of the medications taken by a patient after they have had a liver or kidney transplant to prevent their body from rejecting the new liver or kidney transplant. Prograf is taken by the patient twice a day. Advagraf is a similar medication but is taken by the patient only once a day. There is some evidence emerging that may show that this once-a-day medication may show additional benefits over the twice a day medication, such as, patients more likely to remember to take this medication. Also, this once a day medication is slowly released in the body through the course of a day which in turn may provide better protection against the body rejecting the new transplanted organ over a longer period.

This study will follow up adult patients who were previously enrolled in an Advagraf trial after they have had a liver or kidney transplant. The information collected for this study will be information that the patient's doctor will normally collect when he/she sees the patient for their regular check-ups. Information will be collected once a year for a period of 5 years from when the patient received their new organ transplant. It is hoped that patient information collected during the study will provide prescribers with useful information in treatment of organ transplant patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participated in one of the selected Astellas sponsored clinical trials :

• DIAMOND - PMR-EC-1106

• ADVANCE - PMR-EC-1211

• ADHERE - PMR-EC-1212

• Or, any potential new Astellas-sponsored Advagraf trial

• Assigned to treatment with Advagraf in one of the selected Astellas sponsored clinical trials and received a kidney or liver organ transplant.

NOTE: The primary objective is to study long-term graft survival in patients currently or previously treated with Advagraf. Therefore patients do not have to be currently receiving Advagraf to be included, nor do they have to have completed a previous Astellas clinical trial.

Exclusion Criteria:

• No exclusion criteria

Related Conditions & MeSH terms

• Kidney Transplant
• Liver Transplant

Intervention

Drug:
• Tacrolimus
oral

Locations

Country	Name	City	State
Austria	Site AT43001	Innsbruck
Austria	Site AT43003	Linz
Austria	Site AT43002	Vienna
Belarus	Site BY37501	Minsk
Belgium	Site BE32002	Brussels
Belgium	Site BE32007	Brussels	Brussels Hoofdstedelijk Gewest
Belgium	Site BE32001	Gent
Belgium	Site BE32003	Leuven
Belgium	Site BE32005	Leuven
Belgium	Site BE32008	Liege
Belgium	Site BE32009	Liege
Canada	Site CA15001	Halifax	Nova Scotia
Canada	Site CA15003	Montreal	Quebec
Czechia	Site CZ42006	Brno
Czechia	Site CZ42004	Hradec Kralove
Czechia	Site CZ42003	Olomouc
Czechia	Site CZ42005	Ostrava
Czechia	Site CZ42001	Prague 4
Czechia	Site CZ42002	Prague 4
Estonia	Site EE37201	Tartu
Finland	Site FI35801	Helsinki
Finland	Site FI35802	Helsinki
France	Site FR33020	Angers Cedex 09
France	Site FR33007	Besancon
France	Site FR33012	Bordeaux
France	Site FR33025	Brest
France	Site FR33027	Clermont-Ferrand
France	Site FR33003	Clichy, Paris
France	Site FR33001	Creteil
France	Site FR33029	Creteil
France	Site FR33032	Dijon
France	Site FR33026	Le Kremlin Bicetre
France	Site FR33018	Limoges Cedex 1
France	Site FR33011	Marseille Cedex 05
France	Site FR33014	Montpellier Cedex 05
France	Site FR33023	Nantes Cedex 01
France	Site FR33015	Nice Cedex 1
France	Site FR33004	Nice Cedex 3
France	Site FR33008	Paris
France	Site FR33010	Paris cedex 13
France	Site FR33031	Paris Cedex 15
France	Site FR33019	Paris Cedex 20
France	Site FR33024	Rouen Cedex
France	Site FR33022	Saint Etienne
France	Site FR33017	Strasbourg
France	Site FR33034	Toulouse Cedex 4
France	Site FR33009	Tours
France	Site FR33030	Tours Cedex
France	Site FR33028	Vandoeuvre les Nancy
France	Site FR33002	Villejuif
Germany	Site DE49011	Aachen
Germany	Site DE49004	Berlin
Germany	Site DE49019	Bochum
Germany	Site DE49013	Dusseldorf
Germany	Site DE49030	Essen
Germany	Site DE49001	Frankfurt am Main
Germany	Site DE49014	Halle
Germany	Site DE49005	Hannover
Germany	Site DE49018	Hannover
Germany	Site DE49022	Hannoversch Munden
Germany	Site DE49008	Jena
Germany	Site DE49015	Kaiserslautern
Germany	Site DE49002	Kiel
Germany	Site DE49027	Mannheim
Germany	Site DE49016	Munich
Germany	Site DE49025	Munich
Germany	Site DE49010	Regensburg
Germany	Site DE49017	Rostock
Germany	Site DE49006	Tubingen
Hungary	Site HU36001	Budapest
Hungary	Site HU36003	Debrecen
Hungary	Site HU36002	Szeged
Ireland	Site IE35301	Dublin
Italy	Site IT39015	Ancona
Italy	Site IT39003	Bergamo
Italy	Site IT39005	Bologna
Italy	Site IT39013	Bologna
Italy	Site IT39006	Genova
Italy	Site IT39014	L'Aquila
Italy	Site IT39009	Milan
Italy	Site IT39012	Milan
Italy	Site IT39008	Naples
Italy	Site IT39002	Padova
Italy	Site IT39010	Padova
Italy	Site IT39016	Palermo
Italy	Site IT39004	Rome
Italy	Site IT39020	Rome
Italy	Site IT39017	Salerno
Italy	Site IT39019	Siena
Italy	Site IT39021	Treviso
Italy	Site IT39001	Udine
Italy	Site IT39011	Vicenza
Korea, Republic of	Site KR82007	Busan
Korea, Republic of	Site KR82006	Daegu
Korea, Republic of	Site KR82001	Seoul
Korea, Republic of	Site KR82002	Seoul
Korea, Republic of	Site KR82005	Seoul
Latvia	Site LV37101	Riga
Netherlands	Site NL31001	Maastricht
Poland	Site PL48003	Gdansk
Poland	Site PL48006	Katowice
Poland	Site PL48005	Lodz
Poland	Site PL48007	Poznan
Poland	Site PL48004	Szczecin
Poland	Site PL48001	Warsaw
Portugal	Site PT35102	Lisbon
Romania	Site RO40001	Bucharest
Romania	Site RO40003	Bucharest
Russian Federation	Site RU70012	Ekaterinburg
Russian Federation	Site RU70014	Kemerovo
Russian Federation	Site RU70002	Moscow
Russian Federation	Site RU70004	Moscow
Russian Federation	Site RU70005	Moscow
Russian Federation	Site RU70007	Moscow
Russian Federation	Site RU70010	Omsk
Russian Federation	Site RU70011	Volzhskiy
Russian Federation	Site RU70013	Volzhskiy
Slovakia	Site SK42101	Banska Bystrica
Slovakia	Site SK42102	Bratislava
Spain	Site ES34005	A Coruna
Spain	Site ES34017	Alicante
Spain	Site ES34012	Badalona-Barcelona
Spain	Site ES34019	Barakaldo	Vizcaya
Spain	Site ES34003	Barcelona
Spain	Site ES34004	Barcelona
Spain	Site ES34011	Barcelona
Spain	Site ES34010	Cordoba
Spain	Site ES34001	Hospitalet de Llobregat	Barcelona
Spain	Site ES34018	Hospitalet de Llobregat
Spain	Site ES34006	Madrid
Spain	Site ES34013	Madrid
Spain	Site ES34015	Madrid
Spain	Site ES34020	Santander
Spain	Site ES34014	Sevilla
Spain	Site ES34009	Tenerife
Spain	Site ES34021	Valencia
Spain	Site ES34016	Valladolid
Spain	Site ES34007	Zaragoza
Sweden	Site SE46001	Gothenburg
Sweden	Site SE46002	Stockholm
Sweden	Site SE46004	Uppsala
Switzerland	Site CH41002	Bern
United Kingdom	Site GB44001	Birmingham
United Kingdom	Site GB44003	Leeds
United Kingdom	Site GB44002	London

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Austria,  Belarus,  Belgium,  Canada,  Czechia,  Estonia,  Finland,  France,  Germany,  Hungary,  Ireland,  Italy,  Korea, Republic of,  Latvia,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall graft survival (time to graft loss)	At each annual visit there will be a simple assessment to determine if the graft has survived or not.	Annually from date of transplant and for 5 five years
Secondary	Overall patient survival	At each annual visit there will be a simple assessment to determine if the patient has survived or not.	Annually from date of transplant and for 5 five years
Secondary	Renal Function	At each annual visit serum creatinine results, which is part of routine clinical practice will be collected from the patient's medical records. This will be used by the sponsor to calculate estimated glomerular filtration rate.	Annually from date of transplant and for 5 five years
Secondary	Emergence of de novo Donor Specific Antibody	If the site collects this information as part of routine clinical practice, only then will this information be collected.	Annually from date of transplant and for 5 five years
Secondary	Biopsy proven acute rejection episodes	All rejection episodes captured in the medical records of the patient from one annual visit to the next will be collected for this study	Annually from date of transplant and for 5 five years
Secondary	Immunosuppression regimen	Any immunosuppression regimen, doses and changes in doses from one annual visit to another, as well any annual trough levels of tacrolimus.	Annually from date of transplant and for 5 five years
Secondary	Medical conditions of interest	Medical conditions of interest include, diabetes mellitus, and cardiovascular conditions such as myocardial infarction and strokes.	Annually from date of transplant and for 5 five years
Secondary	Infections of interest	Infections of interest include cytomegalovirus and BK virus	Annually from date of transplant and for 5 five years

External Links

•   Link to results on the Astellas Clinical Study Results Web site