Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients converted from tacrolimus BD to Advagraf<br>Oral | Drug: Tacrolimus<br>* oral<br>* Other names: Prograf XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function as measured by eGFR using the CKD-Epi formula | Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) | 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 | 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 | 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 | From transplantation to EOS (up to 5 years post conversion) | 
| 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 | 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 | From transplantation to EOS (up to 5 years post conversion) | 
| 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 | Dose and formulation (additional to or instead of Advagraf) | 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 | From transplantation to EOS (up to 5 years post conversion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FK506E, Tacrolimus, Observational, Kidney transplantation, Advagraf