The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients

Chiesi

Status: Completed

Conditions: Kidney Transplant

Treatments: Drug: Immunosuppressive

Study type: Observational

Funder types: Industry

Identifiers

NCT03558373

DFIDM-1701

Details and patient eligibility

About

Non-adherence is widespread in the transplant community. Addressing issues associated with non-adherence remains a key challenge in transplantation, in part due to the difficulty in assessing its prevalence, as there is currently no 'gold standard' for use in routine clinical practice.

The purpose of this study is to evaluate the non-adherence to immunosuppressive therapy, including tacrolimus once-daily, among Italian kidney transplant recipients receiving. Along with non-adherence evaluation, possible factors related to NA will be investigated (patient-related, condition/disease-related, therapy/treatment-related, etc.).

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months.
2. Recipients with a functioning graft
3. Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months.
4. Patients who have signed informed consent form and privacy form.
5. Patients capable of discernment and able to read and write in Italian language.

Exclusion criteria

1. Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant.
2. Patients who already received a kidney transplant (re-transplant).
3. Patients enrolled or planned to be enrolled in any clinical study.
4. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.