Kidney TransplantationCHORUSNCT02555787
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
An observational study of Kidney Transplantation, run by Astellas Pharma Europe Ltd. at 129 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 4,430 participants
- Where
- 129 sitesin 25 countries
- Study dates
- 5 Mar 2015to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients
Who may be able to join
- 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.
Who cannot join
- Patients currently taking Advagraf treatment
Trial locations and contacts
129 sites in 25 countries.
129 sites in 25 countries
France23 sites
Site FR3308
Amiens, Picardie, 80054
Site FR3314
Angers, Maine-et-Loire, 49933
Site FR3306
Besançon, Doubs, 25030
Site FR3302
Bordeaux, Gironde, 33076
Site FR3311
Brest, Finistère, 29200
Site FR3303
Caen, Calvados, 14033
Site FR3319
Clermont-Ferrand, Puy-de-Dôme, 63003
Site FR3301
Créteil, Île-de-France Region, 94000
Site FR3316
Le Kremlin-Bicêtre, Île-de-France Region, 94275
Site FR3325
Lille, Nord, 59037
Site FR3321
Limoges, Hautte-Vienne, 91211
Site FR3324
Lyon, Auvergne-Rhône-Alpes, 69003
Site FR3315
Marseille, Bouches-du-Rhône, 13385
Site FR3312
Nantes, Loire-Atlantique, 44093 CEDEX 1
Site FR3310
Nice, Alpes-Maritimes, 06000
Site FR3323
Paris, 75475
Site FR3322
Poitiers, Vienne, 86021
Site FR3317
Rennes, Ille-et-Vilaine, 35033
Site FR3307
Rouen, Haute-Normandie, 76031
Site FR3309
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055
Site FR3318
Strasbourg, Alsace, 67091
Site FR3313
Toulouse, Haute-Garonne, 31059
Site FR3305
Tours, Indre-et-Loire, 37044
South Korea18 sites
Site KR8216
Bucheon-si, Gyeonggido, 14584
Site KR8214
Busan, Busan Gwang'yeogsi [Pusan-Kwan, 48775
Site KR8205
Busan, Busan Gwang'yeogsi [Pusan-Kwan, 633-165
Site KR8202
Daegu, Daegu Gwang'yeogsi [Taegu-Kwan, 700-721
Site KR8219
Daegu, Daegu Gwang'yeogsi, 41931
Site KR8207
Daejeon, Daejeon Gwang'yeogsi [Taejon-K, 301-721
Site KR8212
Gwangju, Gwangju Gwang'yeogsi, 61453
Site KR8201
Incheon, Incheon Gwang'yeogsi [Inch'n-K, 21565
Site KR8203
Pusan, Busan Gwang'yeogsi [Pusan-Kwan, 602-739
Site KR8211
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06273
Site KR8210
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351
Site KR8206
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 110-744
Site KR8209
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 130-702
Site KR8204
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 134-701
Site KR8208
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 136-705
Site KR8213
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 8308
Site KR8218
Suwon, Gyeonggido [Kyonggi-do], 16499
Site KR8215
Ulsan, Ulsan Gwang'yeogsi [Ulsan-Kwan, 44033
Italy17 sites
Site IT3905
Bari, 70124
Site IT3902
Bologna, 40138
Site IT3914
Bolzano, 39100
Site IT3901
Genova, 16132
Site IT3904
L’Aquila, 67100
Site IT3903
Naples, Campania, 80131
Site IT3911
Novara, 28100
Site IT3916
Novara, 28100
Site IT3910
Padova, 35100
Site IT3909
Perugia, 06129
Site IT3912
Salerno, 84131
Site IT39013
Salerno, 84134
Site IT3913
Salerno, 84134
Site IT3908
Sassari, 07100
Site IT3915
Udine, 33100
Site IT3906
Venezia, 30031
Site IT3907
Verona, Veneto, 37126
Japan10 sites
Site JP8101
Akita
Site JP8107
Chiba, Chiba
Site JP8106
Kawasaki-shi, Kanagawa
Site JP8108
Nagoya, Aiti
Site JP8102
Niigata
Site JP8110
Nishinomiya, Hyôgo
Site JP8111
Nishinomiya, Hyôgo
Site JP8105
Ōta-ku, Tôkyô
Site JP8104
Shinjuku-Ku, Tôkyô
Site JP8109
Toyoake, Aiti
Australia8 sites
Site AU6107
Camperdown, New South Wales, 2050
Site AU6106
Gosford, New South Wales, 2250
Site AU6111
Harvey Bay, Queensland, 4655
Site AU6110
Nedlands, Western Australia, 6009
Site AU6104
New Lambton, New South Wales, 2305
Site AU6108
North Adelaide, South Australia, 5000
Site AU6105
Perth, Western Australia, 6150
Site AU6103
Westmead, New South Wales, 2145
United Kingdom7 sites
Site GB4405
Exeter, Devon, EX2 5DW
Site GB4407
Ipswich, Suffolk, IP4 5PD
Site GB4401
Leeds, LS9 7TF
Site GB4402
Liverpool, L7 8XP
Site GB4408
London, SW17 0QT
Site GB4406
Manchester, Lancashire, M13 9WL
Site GB4403
Peterborough, Cambridgeshire, PE3 9GZ
Austria4 sites
Site AT4301
Graz, Styria, 8036
Site AT4302
Innsbruck, Tyrol, 6020
Site AT4303
Innsbruck, Tyrol, 6020
Site AT4304
Linz, Upper Austria, 4020
Netherlands4 sites
Site NL3104
Amsterdam, North Holland, 1105
Site NL3105
Groningen, 9713
Site NL3103
Nijmegen, Gelderland, 6525
Site NL3101
Utrecht, 3584
Poland4 sites
Site PL4808
Lublin, Lublin Voivodeship, 20-954
Site PL4806
Poznan, Greater Poland Voivodeship, 60-479
Site PL4807
Szczecin, West Pomeranian Voivodeship, 70-111
Site PL4801
Warsaw, Masovian Voivodeship, 02-507
Romania4 sites
Site RO4001
Bucharest, 022328
Site RO4002
Bucharest, 022328
Site RO4003
Bucharest, 022328
Site RO4004
Cluj-Napoca, Cluj, 400006
Serbia4 sites
Site SB3801
Belgrade, 11000
Site SB3802
Belgrade, 11000
Site SB3804
Niš, Nišavski Okrug, 18000
Site SB3803
Novi Sad, 21000
Germany3 sites
Site DE4903
Hanover, Lower Saxony, 30625
Site DE4902
Mannheim, Baden-Wurttemberg, 68167
Site DE4901
Würzburg, Bavaria, 97080
Spain3 sites
Site ES3401
Barcelona, 08025
Site ES3403
Barcelona, 08036
Site ES3410
Santiago de Compostela, A Coruña, 15706
Taiwan3 sites
Site TW8862
Kaohsiung City, Kaohsiung, 82445
Site TW8863
Taichung, Taichung Municipality, 40705
Site TW8861
Tainan, 704
Thailand3 sites
Site TH6601
Bangkok, Krung Thep Maha Nakhon [Bangko, 10330
Site TH6602
Bangkok, Krung Thep Maha Nakhon [Bangko, 10400
Site TH6603
Khon Kaen, 40002
Hungary2 sites
Site HU3602
Budapest, 1082
Site HU3601
Debrecen, Hajdú-Bihar, 4032
Vietnam2 sites
Site VN8401
Hà Nội, Ha Noi, Thanh Pho, 10000
Site VN8402
Ho Chi Minh City, Ho Chi Minh, Thanh Pho, 70000
Malaysia1 site
Site MY6001
Kuala Lumpur, Wilayah Persekutuan Kuala Lump, 59100
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplantation
- Being tested
- Tacrolimus
- Keywords
- FK506E, Tacrolimus, Observational, Kidney transplantation, Advagraf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called FK506E, Advagraf, Astagraf XL, Prograf XL
oral
| Study group | Role | What they receive |
|---|---|---|
| Patients converted from tacrolimus BD to Advagraf | Oral Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)
Measured: 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
Patients who are lost to follow up or alive at EOS - or at time of analysis will be censored
Measured: From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
Overall graft survival (time to 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
Measured: From transplantation to date of graft loss
DSA status (de novo)
Donor Specific Antibody (DSA). Laboratory assessment performed where possible in accordance with standard of care
Measured: From transplantation to EOS (up to 5 years post conversion)
Incidence of BPAR episodes
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
Measured: From transplantation to EOS (up to 5 years post conversion)
Time to first incidence of BPAR episodes
Severity by Banff classification, treated and untreated, and steroid sensitive or resistant
Measured: From transplantation to EOS (up to 5 years post conversion)
Advagraf dose
Measured: From transplantation to EOS (up to 5 years post conversion)
Tacrolimus trough level
Measured: From transplantation to EOS (up to 5 years post conversion)
Current immunosuppressant regimen
Dose and formulation (additional to or instead of Advagraf)
Measured: From transplantation to EOS (up to 5 years post conversion)
Status of treatment with Advagraf
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
Measured: From transplantation to EOS (up to 5 years post conversion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start5 Mar 2015
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs Europe, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555787
- Sponsor's protocol ID
- 506-MA-1002
- Acronym
- CHORUS
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2015
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
- ClinicalTrials.gov ID
- NCT02555787
- Acronym / sponsor ID
- CHORUS / 506-MA-1002
- Conditions
- Kidney Transplantation
- Keywords
- FK506E, Tacrolimus, Observational, Kidney transplantation, Advagraf
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,430 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients converted from tacrolimus BD to Advagraf | – | Drug: TacrolimusOral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients currently taking Advagraf treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: FK506E, Advagraf, Astagraf XL, Prograf XLoral | Drug | Patients converted from tacrolimus BD to Advagraf |
Primary outcome
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)
10 secondary outcomes
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)
Overall patient survival
Time frame: 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
DSA status (de novo)
Time frame: 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)
Time to first incidence of BPAR episodes
Time frame: From transplantation to EOS (up to 5 years post conversion)
Advagraf dose
Time frame: 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)
Current immunosuppressant regimen
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Affairs Europe study director
Astellas Pharma Europe Ltd.
129 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Astellas Pharma Europe Ltd. at 129 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 129 sites in France, South Korea, Italy, Japan, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.