A Multicenter Study in Liver Transplant Patients Converted From Prograf® to Advagraf® During the First Post-transplantation Year (COBALT)

Astellas

Status: Completed

Conditions: Liver Transplantation

Treatments: Drug: Tacrolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT02143479

FR-ADV-NI-002

Details and patient eligibility

About

A study in which two groups of patients will be analysed; patients converted from Prograf to Advagraf within the first 3 months after transplantation and patients converted from Prograf to Advagraf between 3 months and 1 year after transplantation.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with a liver transplant performed in the previous year and for whom the conversion from Prograf® to Advagraf® was decided by the physician.

Exclusion criteria

• Patient participating in an interventional clinical trial at the time of enrolment into the study.

Trial design

398 participants in 2 patient groups

1:early conversion from Prograf® to Advagraf®

Description:

patients converted from Prograf® to Advagraf® in the first 3 months after transplantation

Treatment:

Drug: Tacrolimus

2:late conversion from Prograf® to Advagraf®

Description:

patients converted from Prograf® to Advagraf® between 3 months and one year after transplantation

Treatment:

Drug: Tacrolimus