Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
CHORUS
Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
1 other identifier
observational
4,430
24 countries
125
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
125 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedOctober 31, 2024
October 1, 2024
7.6 years
September 18, 2015
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
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)
Overall patient survival
From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
Overall graft survival (time to graft loss)
From transplantation to date of graft loss
DSA status (de novo)
From transplantation to EOS (up to 5 years post conversion)
Incidence of BPAR episodes
From transplantation to EOS (up to 5 years post conversion)
- +5 more secondary outcomes
Study Arms (1)
Patients converted from tacrolimus BD to Advagraf
Oral
Interventions
oral
Eligibility Criteria
Kidney transplant recipients
You may qualify if:
- 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.
You may not qualify if:
- Patients currently taking Advagraf treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (129)
Site AU6107
Camperdown, New South Wales, 2050, Australia
Site AU6106
Gosford, New South Wales, 2250, Australia
Site AU6104
New Lambton, New South Wales, 2305, Australia
Site AU6103
Westmead, New South Wales, 2145, Australia
Site AU6111
Harvey Bay, Queensland, 4655, Australia
Site AU6108
North Adelaide, South Australia, 5000, Australia
Site AU6110
Nedlands, Western Australia, 6009, Australia
Site AU6105
Perth, Western Australia, 6150, Australia
Site AT4301
Graz, Styria, 8036, Austria
Site AT4302
Innsbruck, Tyrol, 6020, Austria
Site AT4303
Innsbruck, Tyrol, 6020, Austria
Site AT4304
Linz, Upper Austria, 4020, Austria
Site BE3201
Leuven, Vlaams Brabant, 3000, Belgium
Site CA1001
Vancouver, British Columbia, V6Z 1Y6, Canada
Site CZ4202
Olomouc, 775 20, Czechia
Site FR3310
Nice, Alpes-Maritimes, 06000, France
Site FR3318
Strasbourg, Alsace, 67091, France
Site FR3324
Lyon, Auvergne-Rhône-Alpes, 69003, France
Site FR3315
Marseille, Bouches-du-Rhône, 13385, France
Site FR3303
Caen, Calvados, 14033, France
Site FR3306
Besançon, Doubs, 25030, France
Site FR3311
Brest, Finistère, 29200, France
Site FR3302
Bordeaux, Gironde, 33076, France
Site FR3313
Toulouse, Haute-Garonne, 31059, France
Site FR3307
Rouen, Haute-Normandie, 76031, France
Site FR3321
Limoges, Hautte-Vienne, 91211, France
Site FR3317
Rennes, Ille-et-Vilaine, 35033, France
Site FR3305
Tours, Indre-et-Loire, 37044, France
Site FR3312
Nantes, Loire-Atlantique, 44093 CEDEX 1, France
Site FR3314
Angers, Maine-et-Loire, 49933, France
Site FR3325
Lille, Nord, 59037, France
Site FR3309
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
Site FR3308
Amiens, Picardie, 80054, France
Site FR3319
Clermont-Ferrand, Puy-de-Dôme, 63003, France
Site FR3322
Poitiers, Vienne, 86021, France
Site FR3323
Paris, 75475, France
Site FR3301
Créteil, Île-de-France Region, 94000, France
Site FR3316
Le Kremlin-Bicêtre, Île-de-France Region, 94275, France
Site DE4902
Mannheim, Baden-Wurttemberg, 68167, Germany
Site DE4901
Würzburg, Bavaria, 97080, Germany
Site DE4903
Hanover, Lower Saxony, 30625, Germany
Site GR3002
Athens, 10675, Greece
Site GR3004
Athens, 11528, Greece
Site HK8201
Hong Kong, Hong Kong
Site HK8521
Hong Kong, Hong Kong
Site HU3601
Debrecen, Hajdú-Bihar, 4032, Hungary
Site HU3602
Budapest, 1082, Hungary
Site IT3903
Napoli, Campania, 80131, Italy
Site IT3907
Verona, Veneto, 37126, Italy
Site IT3905
Bari, 70124, Italy
Site IT3902
Bologna, 40138, Italy
Site IT3914
Bolzano, 39100, Italy
Site IT3901
Genova, 16132, Italy
Site IT3904
L’Aquila, 67100, Italy
Site IT3911
Novara, 28100, Italy
Site IT3916
Novara, 28100, Italy
Site IT3910
Padua, 35100, Italy
Site IT3909
Perugia, 06129, Italy
Site IT3912
Salerno, 84131, Italy
Site IT39013
Salerno, 84134, Italy
Site IT3913
Salerno, 84134, Italy
Site IT3908
Sassari, 07100, Italy
Site IT3915
Udine, 33100, Italy
Site IT3906
Venezia, 30031, Italy
Site JP8108
Nagoya, Aiti, Japan
Site JP8109
Toyoake, Aiti, Japan
Site JP8107
Chiba, Chiba, Japan
Site JP8110
Nishinomiya, Hyôgo, Japan
Site JP8111
Nishinomiya, Hyôgo, Japan
Site JP8106
Kawasaki-shi, Kanagawa, Japan
Site JP8105
Ōta-ku, Tôkyô, Japan
Site JP8104
Shinjuku-Ku, Tôkyô, Japan
Site JP8101
Akita, Japan
Site JP8102
Niigata, Japan
Site MY6001
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 59100, Malaysia
Site NL3103
Nijmegen, Gelderland, 6525, Netherlands
Site NL3104
Amsterdam, North Holland, 1105, Netherlands
Site NL3105
Groningen, 9713, Netherlands
Site NL3101
Utrecht, 3584, Netherlands
Site PH6303
Quezon City, National Capital Region, 1102, Philippines
Site PL4806
Poznan, Greater Poland Voivodeship, 60-479, Poland
Site PL4808
Lublin, Lublin Voivodeship, 20-954, Poland
Site PL4801
Warsaw, Masovian Voivodeship, 02-507, Poland
Site PL4807
Szczecin, West Pomeranian Voivodeship, 70-111, Poland
Site PT3511
Porto, 4099-001, Portugal
Site RO4004
Cluj-Napoca, Cluj, 400006, Romania
Site RO4001
Bucharest, 022328, Romania
Site RO4002
Bucharest, 022328, Romania
Site RO4003
Bucharest, 022328, Romania
Site SB3804
Niš, Nišavski Okrug, 18000, Serbia
Site SB3801
Belgrade, 11000, Serbia
Site SB3802
Belgrade, 11000, Serbia
Site SB3803
Novi Sad, 21000, Serbia
Site KR8214
Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48775, South Korea
Site KR8205
Busan, Busan Gwang'yeogsi [Pusan-Kwan, 633-165, South Korea
Site KR8203
Pusan, Busan Gwang'yeogsi [Pusan-Kwan, 602-739, South Korea
Site KR8202
Daegu, Daegu Gwang'yeogsi [Taegu-Kwan, 700-721, South Korea
Site KR8219
Daegu, Daegu Gwang'yeogsi, 41931, South Korea
Site KR8207
Daejeon, Daejeon Gwang'yeogsi [Taejon-K, 301-721, South Korea
Site KR8212
Gwangju, Gwangju Gwang'yeogsi, 61453, South Korea
Site KR8218
Suwon, Gyeonggido [Kyonggi-do], 16499, South Korea
Site KR8216
Bucheon-si, Gyeonggido, 14584, South Korea
Site KR8201
Incheon, Incheon Gwang'yeogsi [Inch'n-K, 21565, South Korea
Site KR8211
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06273, South Korea
Site KR8210
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351, South Korea
Site KR8206
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 110-744, South Korea
Site KR8209
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 130-702, South Korea
Site KR8204
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 134-701, South Korea
Site KR8208
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 136-705, South Korea
Site KR8213
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 8308, South Korea
Site KR8215
Ulsan, Ulsan Gwang'yeogsi [Ulsan-Kwan, 44033, South Korea
Site ES3410
Santiago de Compostela, A Coruña, 15706, Spain
Site ES3401
Barcelona, 08025, Spain
Site ES3403
Barcelona, 08036, Spain
Site TW8862
Kaohsiung City, Kaohsiung, 82445, Taiwan
Site TW8863
Taichung, Taichung Municipality, 40705, Taiwan
Site TW8861
Tainan, 704, Taiwan
Site TH6601
Bangkok, Krung Thep Maha Nakhon [Bangko, 10330, Thailand
Site TH6602
Bangkok, Krung Thep Maha Nakhon [Bangko, 10400, Thailand
Site TH6603
Khon Kaen, 40002, Thailand
Site GB4403
Peterborough, Cambridgeshire, PE3 9GZ, United Kingdom
Site GB4405
Exeter, Devon, EX2 5DW, United Kingdom
Site GB4406
Manchester, Lancashire, M13 9WL, United Kingdom
Site GB4407
Ipswich, Suffolk, IP4 5PD, United Kingdom
Site GB4401
Leeds, LS9 7TF, United Kingdom
Site GB4402
Liverpool, L7 8XP, United Kingdom
Site GB4408
London, SW17 0QT, United Kingdom
Site VN8401
Hà Nội, Ha Noi, Thanh Pho, 10000, Vietnam
Site VN8402
Ho Chi Minh City, Ho Chi Minh, Thanh Pho, 70000, Vietnam
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Affairs Europe
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2015
First Posted
September 22, 2015
Study Start
March 5, 2015
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.