A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®) (OPALE)

Astellas

Status: Completed

Conditions: Renal Transplantation

Treatments: Drug: Tacrolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT02147938

FR-ADV-NI-003

Details and patient eligibility

About

Assessment in a real situation of the conversion conditions, the efficacy and the safety of the treatment with tacrolimus in renal transplant patients converted from the tacrolimus twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up at one year.

Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early (during the first 6 months post-transplantation) or late (between 6 and 12 months post-transplantation).

Enrollment: 578 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Renal transplant patient for less than one year
• Patient where the conversion from Prograf® to Advagraf® has been decided by the doctor

Exclusion criteria

• Patient participating in an interventional clinical trial at the time of inclusion

Trial design

578 participants in 2 patient groups

1: early conversion from Prograf® to Advagraf®

Description:

patients converted during the first 6 months post-transplantation

Treatment:

Drug: Tacrolimus

2: late conversion from Prograf® to Advagraf®

Description:

patients converted between 6 and 12 months post-transplantation

Treatment:

Drug: Tacrolimus