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

Astellas

Status: Completed

Conditions: Kidney Transplantation

Treatments: Drug: Tacrolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT02555787

506-MA-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,430 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,430 participants in 1 patient group

Patients converted from tacrolimus BD to Advagraf

Description:

Oral

Treatment:

Drug: Tacrolimus