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

May 4, 2022 updated by: Chiesi Farmaceutici S.p.A.

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

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bari, Italy
        • A.O.U. Consorziale Policlinico
      • Bologna, Italy
        • A.O.U. Policlinico S.Orsola Malpighi
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Novara, Italy
        • A.O.U. Maggiore della Carità
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Palermo, Italy
        • ARNAS Ospedale Civico
      • Pisa, Italy
        • Ospedale Cisanello
      • Pisa, Italy
        • A.O.U. Pisana P.O. Cisanello
      • Roma, Italy
        • Fondazione Policlinico Univ. Gemelli
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza
      • Varese, Italy
        • A.O. Ospedale Circolo e Fondazione Macchi
      • Verona, Italy
        • A.O.U.I. Ospedale Borgo Trento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Kidney transplant recipients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Baseline and 6 months
ACCEPT score
Time Frame: Baseline and 6 months
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
BAASIS evaluation
Time Frame: Baseline
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.
Baseline
Patients characteristics
Time Frame: Baseline
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.
Baseline
Clinical informations as for clinical practice
Time Frame: Baseline and 6 months
Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)
Baseline and 6 months
Immunosuppressive treatments
Time Frame: Baseline and 6 months
Immunosuppressive treatments description and changes
Baseline and 6 months
Rejections
Time Frame: Baseline and 6 months
Occurrence of rejection episodes
Baseline and 6 months
Graft failure
Time Frame: Baseline and 6 months
Occurrence of graf failure
Baseline and 6 months
Adverse events
Time Frame: Baseline and 6 months
Number of adverse events
Baseline and 6 months
Infections
Time Frame: Baseline and 6 months
Occurrence of infections
Baseline and 6 months
Healthcare cost
Time Frame: 6 months
Assess the healthcare cost (ER admission, hospitalizations)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2018

Primary Completion (Actual)

February 26, 2020

Study Completion (Actual)

February 26, 2020

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DFIDM-1701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Kidney Transplant

Clinical Trials on Immunosuppressive

3
Subscribe