Kidney transplant
Conditions
Interventions
Group 1: A retrospective chart review will be conducted in patients who received a kidney transplant between 2008 and 2014 who were treated with ADVAGRAF and followed up in outpatient nephrology clini
Sponsors
Astellas Pharma Europe Ltd (APEL)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Adults (18 years or older) who received a kidney transplant between 2008 and 2014, with a deceased or living donation, and with exposure to ADVAGRAF. • Patients who received once daily tacrolimus immunosuppressive therapy (ADVAGRAF) de novo or after conversion from tacrolimus twice daily with at least 1 continuous month. • Patient received no more than 3 years tacrolimus b.i.d exposure prior to conversion to ADVAGRAF. • Patient provided written informed consent (patients who are alive at the time of data extraction only).
Exclusion criteria
Exclusion criteria: • Patient with contraindications (as defined in the Summary of Product Characteristics [SmPC]). • Multiorgan transplant recipient. • Patient receiving tacrolimus b.i.d. for longer than 3 years prior to conversion to ADVAGRAF. • Patient switched from other non-tacrolimus immunosuppression regimens to PROGRAF or ADVAGRAF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite endpoint consisting of the following: • Graft loss (re-transplantation, nephrectomy, death, or dialysis) • Biopsy-confirmed acute rejection (BCAR) • Graft dysfunction (defined as estimated glomerular filtration rate [eGFR][modification of diet in renal disease-4 (MDRD-4) of <40ml/min/1.73m2]) | — |
Secondary
| Measure | Time frame |
|---|---|
| • All-cause mortality • Course of kidney function • Histopathology • Diagnosis from protocol biopsy implant (where available) and at 3, and 12 months post-transplant • Diagnosis from indication/for-cause biopsy • Regimen, dosing, and tacrolimus trough levels | — |
Countries
Germany
Contacts
Public ContactMaría Jesús Perez-Inigo
Astellas Pharma Europe Ltd (APEL)
Outcome results
None listed