Kidney Transplantation
Conditions
Keywords
FK506E, Tacrolimus, Observational, Kidney transplantation, Advagraf
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.
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.
Interventions
DRUGTacrolimus
oral
Sponsors
Astellas Pharma Europe Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| Advagraf dose | From transplantation to EOS (up to 5 years post conversion) | — |
| Tacrolimus trough level | From transplantation to EOS (up to 5 years post conversion) | — |
| Current immunosuppressant regimen | From transplantation to EOS (up to 5 years post conversion) | Dose and formulation (additional to or instead of Advagraf) |
| 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 |
| 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 |
Countries
Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Portugal, Romania, Serbia, South Korea, Spain, Taiwan, Thailand, United Kingdom, Vietnam
Outcome results
None listed