The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Transplant
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 158
- Locations
- 12
- Primary Endpoint
- Non aderence
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Non aderence
Time Frame: 6 months
Proportion of non-adherent patients to immunosuppressive therapy as measured by the Basel Assessment of Adherence with Immunosuppressives Scale (BAASIS©-interview). The BAASIS© consists of four items (with a 6-point scale for responses ranging from never (0) to every day (5)) measuring patients' taking, skipping (or drug holidays), timing (\>2 hrs from prescribed time) and dose reduction of drugs. An affirmative answer to any of the first 4 questions results in assignment to the non-adherent group.
Secondary Outcomes
- BAASIS evaluation(Baseline)
- Graft failure(Baseline and 6 months)
- BMQ score(Baseline and 6 months)
- Clinical informations as for clinical practice(Baseline and 6 months)
- ACCEPT score(Baseline and 6 months)
- Rejections(Baseline and 6 months)
- Adverse events(Baseline and 6 months)
- Infections(Baseline and 6 months)
- Healthcare cost(6 months)
- Patients characteristics(Baseline)
- Immunosuppressive treatments(Baseline and 6 months)