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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2020-02-26

Brief Summary

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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.).

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Detailed Description

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Conditions

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Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Immunosuppressive

Immunosuppressive therapies

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No