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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02555787
Registration number
NCT02555787
Ethics application status
Date submitted
18/09/2015
Date registered
22/09/2015
Titles & IDs
Public title
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
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Scientific title
Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)
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Secondary ID [1]
0
0
506-MA-1002
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Universal Trial Number (UTN)
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Trial acronym
CHORUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Tacrolimus
Patients converted from tacrolimus BD to Advagraf - Oral
Treatment: Drugs: Tacrolimus
oral
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Change in renal function as measured by eGFR using the MDRD-4 formula
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Assessment method [1]
0
0
Estimated Glomerular Filtration Rate (eGFR), Modification Diet in Renal Disease (MDRD-4), End of Study (EOS)
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Timepoint [1]
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0
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)
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Secondary outcome [1]
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0
Change in renal function as measured by eGFR using the CKD-Epi formula
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Assessment method [1]
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0
Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)
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Timepoint [1]
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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)
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Secondary outcome [2]
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0
Overall patient survival
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Assessment method [2]
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0
Patients who are lost to follow up or alive at EOS - or at time of analysis will be censored
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Timepoint [2]
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0
From transplantation to EOS (up to 5 years post conversion) or date of death from any cause
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Secondary outcome [3]
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0
Overall graft survival (time to graft loss)
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Assessment method [3]
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0
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
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Timepoint [3]
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From transplantation to date of graft loss
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Secondary outcome [4]
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0
DSA status (de novo)
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Assessment method [4]
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Donor Specific Antibody (DSA). Laboratory assessment performed where possible in accordance with standard of care
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Timepoint [4]
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From transplantation to EOS (up to 5 years post conversion)
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Secondary outcome [5]
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0
Incidence of BPAR episodes
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Assessment method [5]
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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
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Timepoint [5]
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From transplantation to EOS (up to 5 years post conversion)
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Secondary outcome [6]
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Time to first incidence of BPAR episodes
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Assessment method [6]
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Severity by Banff classification, treated and untreated, and steroid sensitive or resistant
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Timepoint [6]
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From transplantation to EOS (up to 5 years post conversion)
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Secondary outcome [7]
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Advagraf dose
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Assessment method [7]
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Timepoint [7]
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From transplantation to EOS (up to 5 years post conversion)
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Secondary outcome [8]
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Tacrolimus trough level
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Assessment method [8]
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Timepoint [8]
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From transplantation to EOS (up to 5 years post conversion)
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Secondary outcome [9]
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Current immunosuppressant regimen
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Assessment method [9]
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Dose and formulation (additional to or instead of Advagraf)
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Timepoint [9]
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From transplantation to EOS (up to 5 years post conversion)
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Secondary outcome [10]
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Status of treatment with Advagraf
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Assessment method [10]
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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
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Timepoint [10]
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From transplantation to EOS (up to 5 years post conversion)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients currently taking Advagraf treatment
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/03/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2022
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Sample size
Target
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Accrual to date
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Final
4430
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Site AU6107 - Camperdown
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2050 - Camperdown
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2250 - Gosford
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4655 - Harvey Bay
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5000 - North Adelaide
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6009 - Nedlands
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6150 - Perth
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Ha Noi, Thanh Pho
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Ho Chi Minh, Thanh Pho
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Astellas Pharma Europe Ltd.
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02555787
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Affairs Europe
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Address
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Astellas Pharma Europe Ltd.
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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."
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02555787