Retrospective real world evaluation of long-term kidney graft survival in patients on ADVAGRAF based immunosuppression at three transplant centres in Germany

• Conditions: Kidney transplant

• Registration Number: DRKS00017485
• Lead Sponsor: Astellas Pharma Europe Ltd (APEL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-04
• Study Completion: 2021-04-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 169

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

• 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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite endpoint consisting of the following:<br><br>• Graft loss (re-transplantation, nephrectomy, death, or dialysis)<br><br>• Biopsy-confirmed acute rejection (BCAR)<br><br>• Graft dysfunction (defined as estimated glomerular filtration rate [eGFR][modification of diet in renal disease-4 (MDRD-4) of <40ml/min/1.73m2])

Secondary Outcome Measures

Name	Time	Method
• All-cause mortality<br><br>• Course of kidney function<br><br>• Histopathology<br><br>• Diagnosis from protocol biopsy implant (where available) and at 3, and 12 months post-transplant<br><br>• Diagnosis from indication/for-cause biopsy<br><br>• Regimen, dosing, and tacrolimus trough levels