NCT02555787

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,430 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	oral

Timeline

• Start date: 2015-03-05
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2015-09-22
• Last updated: 2024-10-31

Locations

129 sites across 25 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