Clincosm LogoSign in Get a demo

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

Sponsor
Astellas Pharma Europe Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02555787
Collaborator
(none)
4,430
Enrollment
129
Locations
91.9
Anticipated Duration (Months)
34.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
4430 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
Actual Study Start Date :
Mar 5, 2015
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients converted from tacrolimus BD to Advagraf

Oral

Drug: Tacrolimus
oral
Other Names:
  • FK506E
  • Advagraf
  • Astagraf XL
  • Prograf XL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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)

    2. 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

    3. 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

    4. 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

    5. 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

    6. 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

    7. Advagraf dose [From transplantation to EOS (up to 5 years post conversion)]

    8. Tacrolimus trough level [From transplantation to EOS (up to 5 years post conversion)]

    9. Current immunosuppressant regimen [From transplantation to EOS (up to 5 years post conversion)]

      Dose and formulation (additional to or instead of Advagraf)

    10. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Astellas Pharma Europe Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Europe Ltd.
    ClinicalTrials.gov Identifier:
    NCT02555787
    Other Study ID Numbers:
    • 506-MA-1002
    First Posted:
    Sep 22, 2015
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Astellas Pharma Europe Ltd.
    FK506E
    Tacrolimus
    Observational
    Kidney transplantation
    Advagraf
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Aug 19, 2022