An observational study in Kidney Transplant, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 12 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Chiesi Farmaceutici S.p.A. · Observational
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.).
Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Kidney transplant recipients
Exclusion criteria:
Immunosuppressive therapies
Non aderence
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.
Time frame: 6 months
BMQ score
Describe the patient's belief about immunosuppresive medicines, as measured by the Belief about Medicines Questionnaire (BMQ). It is an 18-item measure comprising of two subscales (general harm and general overuse), and two subscales (specific necessity and specific concerns). Higher scores in the General-Harm and General-Overuse sub-scales represent an overall negative perception of medication. High scores in the Specific-Concerns sub-scale means that adverse reactions are potentially harmful and high scores in the Specific-Necessity sub-scale are indicative of the patient's need to adhere to medication to maintain health.
Time frame: Baseline and 6 months
ACCEPT score
Describe the patient's acceptance toward immunosuppressive treatment, as measured by the ACCEPT questionnaire. It is a 32-items self-administered questionnaire and covers patient's opinion on: convenience of the medication, length of treatment, constraints due to medication, side effects and a general opinion on the medication. The score ranges from 0 (no acceptance) to 100 (maximum treatment acceptance).
Time frame: Baseline and 6 months
BAASIS evaluation
Perform the BAASIS assessement.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.
Time frame: Baseline
Patients characteristics
Describe patients characteristics (such as socio-demographics, lifestyle information, relevant comorbidities, concomitant medications, clinical characteristics information like e.g. primary kidney disease diagnosis, waiting time before graft, transplant characteristic e.g. type of donor, etc.
Time frame: Baseline
Clinical informations as for clinical practice
Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)
Time frame: Baseline and 6 months
Immunosuppressive treatments
Immunosuppressive treatments description and changes
Time frame: Baseline and 6 months
Rejections
Occurrence of rejection episodes
Time frame: Baseline and 6 months
Graft failure
Occurrence of graf failure
Time frame: Baseline and 6 months
Adverse events
Number of adverse events
Time frame: Baseline and 6 months
Infections
Occurrence of infections
Time frame: Baseline and 6 months
Healthcare cost
Assess the healthcare cost (ER admission, hospitalizations)
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Chiesi Farmaceutici S.p.A.