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

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Tacrolimus

• Registration Number: NCT02555787
• Lead Sponsor: Astellas Pharma Europe Ltd.

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.

Study Timeline

• Study Start: 2015-03-05
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4430

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients converted from tacrolimus BD to Advagraf	Tacrolimus	Oral

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Tacrolimus trough level	From transplantation to EOS (up to 5 years post conversion)
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)
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
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
Current immunosuppressant regimen	From transplantation to EOS (up to 5 years post conversion)	Dose and formulation (additional to or instead of Advagraf)
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
Advagraf dose	From transplantation to EOS (up to 5 years post conversion)
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

Trial Locations

Locations (129)

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 AT4304; 🇦🇹 Linz, Oberösterreich, Austria

Site AT4301; 🇦🇹 Graz, Steiermark, Austria

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