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

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Tacrolimus

• Registration Number: NCT02555787
• Lead Sponsor: Astellas Pharma Europe Ltd.

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.

Study Timeline

• Study Start: 2015-03-05
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4430

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients converted from tacrolimus BD to Advagraf	Tacrolimus	Oral

Primary Outcome Measures

Name	Time	Method
Change in renal function as measured by eGFR using the MDRD-4 formula	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)	Estimated Glomerular Filtration Rate (eGFR), Modification Diet in Renal Disease (MDRD-4), End of Study (EOS)

Secondary Outcome Measures

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

Trial Locations

Locations (129)

Site DE4902; 🇩🇪 Mannheim, Baden-Württemberg, Germany

Site IT3915; 🇮🇹 Udine, Italy

Site FR3323; 🇫🇷 Paris, France

Site AU6110; 🇦🇺 Nedlands, Western Australia, Australia

Site FR3315; 🇫🇷 Marseille Cedex 5, Bouches-du-Rhône, France

Site GB4407; 🇬🇧 Ipswich, Suffolk, United Kingdom

Site FR3314; 🇫🇷 Angers, Maine-et-Loire, France

Site FR3301; 🇫🇷 Creteil, Île-de-France, France

Site FR3316; 🇫🇷 Le Kremlin Bicetre Cedex, Île-de-France, France

Site FR3312; 🇫🇷 Nantes, Loire-Atlantique, France

Site FR3325; 🇫🇷 Lille, Nord, France

Site AT4303; 🇦🇹 Innsbruck, Tirol, Austria

Site FR3318; 🇫🇷 Strasbourg, Alsace, France

Site FR3306; 🇫🇷 Besancon Cedex, Doubs, France

Site FR3317; 🇫🇷 Rennes Cedex, Ille-et-Vilaine, France

Site FR3319; 🇫🇷 Clermont Ferrand Cedex 1, Puy-de-Dôme, France

Site JP8105; 🇯🇵 Ota-ku, Tôkyô, Japan

Site JP8104; 🇯🇵 Shinjuku-Ku, Tôkyô, Japan

Site JP8101; 🇯🇵 Akita, Japan

Site SB3803; 🇷🇸 Novi Sad, Serbia

Site GB4405; 🇬🇧 Exeter, Devon, United Kingdom

Site VN8402; 🇻🇳 Ho Chi Minh, Ho Chi Minh, Thanh Pho, Vietnam

Site FR3322; 🇫🇷 POITIERS cedex, Vienne, France

Site RO4001; 🇷🇴 Bucuresti, Romania

Site JP8108; 🇯🇵 Nagoya-shi, Aiti, Japan

Site JP8110; 🇯🇵 Nishinomiya, Hyôgo, Japan

Site PT3511; 🇵🇹 Porto, Portugal

Site FR3311; 🇫🇷 Brest, Finistère, France

Site FR3309; 🇫🇷 Saint-Etienne Cedex 2, Loire, France

Site JP8102; 🇯🇵 Niigata, Japan

Site MY6001; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia

Site PH6303; 🇵🇭 Quezon City, National Capital Region, Philippines

Site PL4808; 🇵🇱 Lublin, Lubelskie, Poland

Site PL4807; 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Site RO4004; 🇷🇴 Cluj-Napoca;, Cluj, Romania

Site RO4002; 🇷🇴 Bucuresti, Romania

Site FR3302; 🇫🇷 Bordeaux, Gironde, France

Site ES3410; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Site JP8106; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

Site NL3101; 🇳🇱 Utrecht, Netherlands

Site TW8862; 🇨🇳 Kaohsiung City, Kaohsiung, Taiwan

Site IT3910; 🇮🇹 Padova, Italy

Site IT3911; 🇮🇹 Novara, Italy

Site TW8863; 🇨🇳 Taichung, Taichung Municipality, Taiwan

Site FR3305; 🇫🇷 Tours, Indre-et-Loire, France

Site IT3902; 🇮🇹 Bologna, Italy

Site AU6103; 🇦🇺 Westmead, New South Wales, Australia

Site AU6107; 🇦🇺 Camperdown, New South Wales, Australia

Site AU6104; 🇦🇺 New Lambton, New South Wales, Australia

Site AU6106; 🇦🇺 Gosford, New South Wales, Australia

Site AU6111; 🇦🇺 Harvey Bay, Queensland, Australia

Site AU6108; 🇦🇺 North Adelaide, South Australia, Australia

Site AT4302; 🇦🇹 Innsbruck, Tirol, Austria

Site AU6105; 🇦🇺 Perth, Western Australia, Australia

Site AT4304; 🇦🇹 Linz, Oberösterreich, Austria

Site AT4301; 🇦🇹 Graz, Steiermark, Austria

Site FR3310; 🇫🇷 Nice, Alpes-Maritimes, France

Site CA1001; 🇨🇦 Vancouver, British Columbia, Canada

Site CZ4202; 🇨🇿 Olomouc, Czechia

Site BE3201; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Site FR3303; 🇫🇷 Caen, Calvados, France

Site FR3321; 🇫🇷 Limoges, Hautte-Vienne, France

Site FR3313; 🇫🇷 Toulouse, Haute-Garonne, France

Site FR3307; 🇫🇷 ROUEN cedex, Haute-Normandie, France

Site FR3308; 🇫🇷 Amiens Cedex 1, Picardie, France

Site FR3324; 🇫🇷 Lyon Cedex 03, Rhône-Alpes, France

Site DE4901; 🇩🇪 Wuerzburg, Bayern, Germany

Site DE4903; 🇩🇪 Hannover, Niedersachsen, Germany

Site GR3002; 🇬🇷 Athens, Greece

Site HU3601; 🇭🇺 Debrecen, Hajdú-Bihar, Hungary

Site HU3602; 🇭🇺 Budapest, Hungary

Site GR3004; 🇬🇷 Athens, Greece

Site IT3907; 🇮🇹 Verona, Veneto, Italy

Site IT3905; 🇮🇹 Bari, Italy

Site IT3904; 🇮🇹 L'Aquila, Italy

Site IT3914; 🇮🇹 Bolzano, Italy

Site IT3901; 🇮🇹 Genova, Italy

Site IT3916; 🇮🇹 Novara, Italy

Site IT3909; 🇮🇹 Perugia, Italy

Site IT3912; 🇮🇹 Salerno, Italy

Site IT39013; 🇮🇹 Salerno, Italy

Site IT3913; 🇮🇹 Salerno, Italy

Site IT3908; 🇮🇹 Sassari, Italy

Site IT3906; 🇮🇹 Venezia, Italy

Site JP8109; 🇯🇵 Toyoake, Aiti, Japan

Site JP8111; 🇯🇵 Nishinomiya, Hyôgo, Japan

Site JP8107; 🇯🇵 Chiba, Tiba, Japan

Site KR8203; 🇰🇷 Pusan, 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 KR8205; 🇰🇷 Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of

Site KR8207; 🇰🇷 Daejeon, Daejeon Gwang'yeogsi [Taejon-K, Korea, Republic of

Site KR8219; 🇰🇷 Daegu, Daegu Gwang'yeogsi, Korea, Republic of

Site KR8212; 🇰🇷 Gwangju, Gwangju Gwang'yeogsi, Korea, Republic of

Site KR8218; 🇰🇷 Suwon, Gyeonggido [Kyonggi-do], Korea, Republic of

Site KR8216; 🇰🇷 Bucheon-city, Gyeonggido, Korea, Republic of

Site KR8201; 🇰🇷 Incheon, Incheon Gwang'yeogsi [Inch'n-K, 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 KR8206; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Site NL3104; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Site KR8209; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Site KR8215; 🇰🇷 Ulsan, Ulsan Gwang'yeogsi [Ulsan-Kwan, Korea, Republic of

Site KR8204; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Site KR8208; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Site KR8213; 🇰🇷 Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of

Site NL3103; 🇳🇱 Nijmegen, Gelderland, Netherlands

Site NL3105; 🇳🇱 Groningen, Netherlands

Site PL4801; 🇵🇱 Warszawa, Mazowieckie, Poland

Site PL4806; 🇵🇱 Poznan, Wielkopolskie, Poland

Site SB3801; 🇷🇸 Belgrade, Serbia

Site SB3804; 🇷🇸 Niš, Nišavski Okrug, Serbia

Site RO4003; 🇷🇴 Bucuresti, Romania

Site SB3802; 🇷🇸 Belgrade, Serbia

Site ES3401; 🇪🇸 Barcelona, Spain

Site ES3403; 🇪🇸 Barcelona, Spain

Site TW8861; 🇨🇳 Tainan, Taiwan

Site TH6601; 🇹🇭 Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

Site TH6602; 🇹🇭 Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand

Site GB4403; 🇬🇧 Peterborough, Cambridgeshire, United Kingdom

Site GB4408; 🇬🇧 London, United Kingdom

Site GB4406; 🇬🇧 Manchester, Lancashire, United Kingdom

Site TH6603; 🇹🇭 Khon Kaen, Thailand

Site VN8401; 🇻🇳 Ha Noi, Ha Noi, Thanh Pho, Vietnam

Site GB4402; 🇬🇧 Liverpool, United Kingdom

Site GB4401; 🇬🇧 Leeds, United Kingdom

Site IT3903; 🇮🇹 Napoli, Campania, Italy

Site HK8521; 🇭🇰 Hong Kong, Hong Kong

Site HK8201; 🇭🇰 Hong Kong, Hong Kong