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.
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
4,430
oral
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)
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)
Change in renal function as measured by eGFR using the CKD-Epi formula
Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi)
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
Patients who are lost to follow up or alive at EOS - or at time of analysis will be censored
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)
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
Time frame: 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
Time frame: From transplantation to EOS (up to 5 years post conversion)
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Site AU6107
Camperdown, New South Wales, Australia
Site AU6106
Gosford, New South Wales, Australia
Site AU6104
New Lambton, New South Wales, Australia
Site AU6103
Westmead, New South Wales, Australia
Site AU6111
Harvey Bay, Queensland, Australia
Site AU6108
North Adelaide, South Australia, Australia
Site AU6110
Nedlands, Western Australia, Australia
Site AU6105
Perth, Western Australia, Australia
Site AT4301
Graz, Styria, Austria
Site AT4302
Innsbruck, Tyrol, Austria
...and 119 more locations
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
Time frame: 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
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
Dose and formulation (additional to or instead of Advagraf)
Time frame: 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
Time frame: From transplantation to EOS (up to 5 years post conversion)