- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558373
The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients
The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study
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.).
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bari, Italy
- A.O.U. Consorziale Policlinico
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Bologna, Italy
- A.O.U. Policlinico S.Orsola Malpighi
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Milano, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Novara, Italy
- A.O.U. Maggiore della Carità
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Padova, Italy
- Azienda Ospedaliera di Padova
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Palermo, Italy
- ARNAS Ospedale Civico
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Pisa, Italy
- Ospedale Cisanello
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Pisa, Italy
- A.O.U. Pisana P.O. Cisanello
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Roma, Italy
- Fondazione Policlinico Univ. Gemelli
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Torino, Italy
- A.O.U. Città della Salute e della Scienza
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Varese, Italy
- A.O. Ospedale Circolo e Fondazione Macchi
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Verona, Italy
- A.O.U.I. Ospedale Borgo Trento
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months.
- Recipients with a functioning graft
- Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months.
- Patients who have signed informed consent form and privacy form.
- Patients capable of discernment and able to read and write in Italian language.
Exclusion criteria:
- Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant.
- Patients who already received a kidney transplant (re-transplant).
- Patients enrolled or planned to be enrolled in any clinical study.
- Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMQ score
Time Frame: Baseline and 6 months
|
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.
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Baseline and 6 months
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ACCEPT score
Time Frame: Baseline and 6 months
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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).
|
Baseline and 6 months
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BAASIS evaluation
Time Frame: Baseline
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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.
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Baseline
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Patients characteristics
Time Frame: Baseline
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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.
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Baseline
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Clinical informations as for clinical practice
Time Frame: Baseline and 6 months
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Collect clinical information (e.g.
routine tacrolimus trough levels, eGFR if available)
|
Baseline and 6 months
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Immunosuppressive treatments
Time Frame: Baseline and 6 months
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Immunosuppressive treatments description and changes
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Baseline and 6 months
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Rejections
Time Frame: Baseline and 6 months
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Occurrence of rejection episodes
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Baseline and 6 months
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Graft failure
Time Frame: Baseline and 6 months
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Occurrence of graf failure
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Baseline and 6 months
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Adverse events
Time Frame: Baseline and 6 months
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Number of adverse events
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Baseline and 6 months
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Infections
Time Frame: Baseline and 6 months
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Occurrence of infections
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Baseline and 6 months
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Healthcare cost
Time Frame: 6 months
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Assess the healthcare cost (ER admission, hospitalizations)
|
6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DFIDM-1701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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