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

November 10, 2022 updated by: Astellas Pharma Europe Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Site AU6107
      • Gosford, New South Wales, Australia, 2250
        • Site AU6106
      • New Lambton, New South Wales, Australia, 2305
        • Site AU6104
      • Westmead, New South Wales, Australia, 2145
        • Site AU6103
    • Queensland
      • Harvey Bay, Queensland, Australia, 4655
        • Site AU6111
    • South Australia
      • North Adelaide, South Australia, Australia, 5000
        • Site AU6108
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Site AU6110
      • Perth, Western Australia, Australia, 6150
        • Site AU6105
  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Site AT4304
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Site AT4301
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Site AT4302
      • Innsbruck, Tirol, Austria, 6020
        • Site AT4303
  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Site BE3201
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Site CA1001
  • Czechia
      • Olomouc, Czechia, 775 20
        • Site CZ4202
  • France
      • Paris, France, 75475
        • Site FR3323
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06000
        • Site FR3310
    • Alsace
      • Strasbourg, Alsace, France, 67091
        • Site FR3318
    • Bouches-du-Rhône
      • Marseille Cedex 5, Bouches-du-Rhône, France, 13385
        • Site FR3315
    • Calvados
      • Caen, Calvados, France, 14033
        • Site FR3303
    • Doubs
      • Besancon Cedex, Doubs, France, 25030
        • Site FR3306
    • Finistère
      • Brest, Finistère, France, 29200
        • Site FR3311
    • Gironde
      • Bordeaux, Gironde, France, 33076
        • Site FR3302
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Site FR3313
    • Haute-Normandie
      • ROUEN cedex, Haute-Normandie, France, 76031
        • Site FR3307
    • Hautte-Vienne
      • Limoges, Hautte-Vienne, France, 91211
        • Site FR3321
    • Ille-et-Vilaine
      • Rennes Cedex, Ille-et-Vilaine, France, 35033
        • Site FR3317
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Site FR3305
    • Loire
      • Saint-Etienne Cedex 2, Loire, France, 42055
        • Site FR3309
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093 CEDEX 1
        • Site FR3312
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Site FR3314
    • Nord
      • Lille, Nord, France, 59037
        • Site FR3325
    • Picardie
      • Amiens Cedex 1, Picardie, France, 80054
        • Site FR3308
    • Puy-de-Dôme
      • Clermont Ferrand Cedex 1, Puy-de-Dôme, France, 63003
        • Site FR3319
    • Rhône-Alpes
      • Lyon Cedex 03, Rhône-Alpes, France, 69003
        • Site FR3324
    • Vienne
      • POITIERS cedex, Vienne, France, 86021
        • Site FR3322
    • Île-de-France
      • Creteil, Île-de-France, France, 94000
        • Site FR3301
      • Le Kremlin Bicetre Cedex, Île-de-France, France, 94275
        • Site FR3316
  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Site DE4902
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • Site DE4901
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Site DE4903
  • Greece
      • Athens, Greece, 10675
        • Site GR3002
      • Athens, Greece, 11528
        • Site GR3004
  • Hong Kong
      • Hong Kong, Hong Kong
        • Site HK8201
      • Hong Kong, Hong Kong
        • Site HK8521
  • Hungary
      • Budapest, Hungary, 1082
        • Site HU3602
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Site HU3601
  • Italy
      • Bari, Italy, 70124
        • Site IT3905
      • Bologna, Italy, 40138
        • Site IT3902
      • Bolzano, Italy, 39100
        • Site IT3914
      • Genova, Italy, 16132
        • Site IT3901
      • L'Aquila, Italy, 67100
        • Site IT3904
      • Novara, Italy, 28100
        • Site IT3911
      • Novara, Italy, 28100
        • Site IT3916
      • Padova, Italy, 35100
        • Site IT3910
      • Perugia, Italy, 06129
        • Site IT3909
      • Salerno, Italy, 84131
        • Site IT3912
      • Salerno, Italy, 84134
        • Site IT39013
      • Salerno, Italy, 84134
        • Site IT3913
      • Sassari, Italy, 07100
        • Site IT3908
      • Udine, Italy, 33100
        • Site IT3915
      • Venezia, Italy, 30031
        • Site IT3906
    • Campania
      • Napoli, Campania, Italy, 80131
        • Site IT3903
    • Veneto
      • Verona, Veneto, Italy, 37126
        • Site IT3907
  • Japan
      • Akita, Japan
        • Site JP8101
      • Niigata, Japan
        • Site JP8102
    • Aiti
      • Nagoya-shi, Aiti, Japan
        • Site JP8108
      • Toyoake, Aiti, Japan
        • Site JP8109
    • Hyôgo
      • Nishinomiya, Hyôgo, Japan
        • Site JP8110
      • Nishinomiya, Hyôgo, Japan
        • Site JP8111
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan
        • Site JP8106
    • Tiba
      • Chiba, Tiba, Japan
        • Site JP8107
    • Tôkyô
      • Ota-ku, Tôkyô, Japan
        • Site JP8105
      • Shinjuku-Ku, Tôkyô, Japan
        • Site JP8104
  • Korea, Republic of
    • Busan Gwang'yeogsi [Pusan-Kwan
      • Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of, 48775
        • Site KR8214
      • Busan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of, 633-165
        • Site KR8205
      • Pusan, Busan Gwang'yeogsi [Pusan-Kwan, Korea, Republic of, 602-739
        • Site KR8203
    • Daegu Gwang'yeogsi
      • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 41931
        • Site KR8219
    • Daegu Gwang'yeogsi [Taegu-Kwan
      • Daegu, Daegu Gwang'yeogsi [Taegu-Kwan, Korea, Republic of, 700-721
        • Site KR8202
    • Daejeon Gwang'yeogsi [Taejon-K
      • Daejeon, Daejeon Gwang'yeogsi [Taejon-K, Korea, Republic of, 301-721
        • Site KR8207
    • Gwangju Gwang'yeogsi
      • Gwangju, Gwangju Gwang'yeogsi, Korea, Republic of, 61453
        • Site KR8212
    • Gyeonggido
      • Bucheon-city, Gyeonggido, Korea, Republic of, 14584
        • Site KR8216
    • Gyeonggido [Kyonggi-do]
      • Suwon, Gyeonggido [Kyonggi-do], Korea, Republic of, 16499
        • Site KR8218
    • Incheon Gwang'yeogsi [Inch'n-K
      • Incheon, Incheon Gwang'yeogsi [Inch'n-K, Korea, Republic of, 21565
        • Site KR8201
    • Seoul Teugbyeolsi [Seoul-T'ukp
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 06273
        • Site KR8211
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 06351
        • Site KR8210
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 110-744
        • Site KR8206
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 130-702
        • Site KR8209
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 134-701
        • Site KR8204
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 136-705
        • Site KR8208
      • Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of, 8308
        • Site KR8213
    • Ulsan Gwang'yeogsi [Ulsan-Kwan
      • Ulsan, Ulsan Gwang'yeogsi [Ulsan-Kwan, Korea, Republic of, 44033
        • Site KR8215
  • Malaysia
    • Wilayah Persekutuan Kuala Lump
      • Kuala Lumpur, Wilayah Persekutuan Kuala Lump, Malaysia, 59100
        • Site MY6001
  • Netherlands
      • Groningen, Netherlands, 9713
        • Site NL3105
      • Utrecht, Netherlands, 3584
        • Site NL3101
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525
        • Site NL3103
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105
        • Site NL3104
  • Philippines
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1102
        • Site PH6303
  • Poland
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-954
        • Site PL4808
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-507
        • Site PL4801
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-479
        • Site PL4806
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-111
        • Site PL4807
  • Portugal
      • Porto, Portugal, 4099-001
        • Site PT3511
  • Romania
      • Bucuresti, Romania, 022328
        • Site RO4001
      • Bucuresti, Romania, 022328
        • Site RO4002
      • Bucuresti, Romania, 022328
        • Site RO4003
    • Cluj
      • Cluj-Napoca;, Cluj, Romania, 400006
        • Site RO4004
  • Serbia
      • Belgrade, Serbia, 11000
        • Site SB3801
      • Belgrade, Serbia, 11000
        • Site SB3802
      • Novi Sad, Serbia, 21000
        • Site SB3803
    • Nišavski Okrug
      • Niš, Nišavski Okrug, Serbia, 18000
        • Site SB3804
  • Spain
      • Barcelona, Spain, 08025
        • Site ES3401
      • Barcelona, Spain, 08036
        • Site ES3403
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Site ES3410
  • Taiwan
      • Tainan, Taiwan, 704
        • Site TW8861
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Taiwan, 82445
        • Site TW8862
    • Taichung Municipality
      • Taichung, Taichung Municipality, Taiwan, 40705
        • Site TW8863
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Site TH6603
    • Krung Thep Maha Nakhon [Bangko
      • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10330
        • Site TH6601
      • Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10400
        • Site TH6602
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Site GB4401
      • Liverpool, United Kingdom, L7 8XP
        • Site GB4402
      • London, United Kingdom, SW17 0QT
        • Site GB4408
    • Cambridgeshire
      • Peterborough, Cambridgeshire, United Kingdom, PE3 9GZ
        • Site GB4403
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Site GB4405
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Site GB4406
    • Suffolk
      • Ipswich, Suffolk, United Kingdom, IP4 5PD
        • Site GB4407
  • Vietnam
    • Ha Noi, Thanh Pho
      • Ha Noi, Ha Noi, Thanh Pho, Vietnam, 10000
        • Site VN8401
    • Ho Chi Minh, Thanh Pho
      • Ho Chi Minh, Ho Chi Minh, Thanh Pho, Vietnam, 70000
        • Site VN8402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Kidney transplant recipients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients converted from tacrolimus BD to Advagraf
Oral
Drug: Tacrolimus
oral
Other Names:
  • Advagraf
  • FK506E
  • Astagraf XL
  • Prograf XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renal function as measured by eGFR using the MDRD-4 formula
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renal function as measured by eGFR using the CKD-Epi formula
Time Frame: 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)
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
Time Frame: 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
From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
Overall graft survival (time to graft loss)
Time Frame: 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
From transplantation to date of graft loss
DSA status (de novo)
Time Frame: 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
From transplantation to EOS (up to 5 years post conversion)
Incidence of BPAR episodes
Time Frame: 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
From transplantation to EOS (up to 5 years post conversion)
Time to first incidence of BPAR episodes
Time Frame: From transplantation to EOS (up to 5 years post conversion)
Severity by Banff classification, treated and untreated, and steroid sensitive or resistant
From transplantation to EOS (up to 5 years post conversion)
Advagraf dose
Time Frame: From transplantation to EOS (up to 5 years post conversion)
From transplantation to EOS (up to 5 years post conversion)
Tacrolimus trough level
Time Frame: From transplantation to EOS (up to 5 years post conversion)
From transplantation to EOS (up to 5 years post conversion)
Current immunosuppressant regimen
Time Frame: From transplantation to EOS (up to 5 years post conversion)
Dose and formulation (additional to or instead of Advagraf)
From transplantation to EOS (up to 5 years post conversion)
Status of treatment with Advagraf
Time Frame: 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
From transplantation to EOS (up to 5 years post conversion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe Ltd.

Investigators

  • Study Director: Medical Affairs Europe, Astellas Pharma Europe Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2015

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 506-MA-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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