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Completed

NCT Number: NCT03558373

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

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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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O.U. Consorziale Policlinico, Bari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immunosuppressive

Drug

Immunosuppressive therapies

Primary outcomes

  1. 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

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. Clinical informations as for clinical practice

    Time frame: Baseline and 6 months

    Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)

  6. Immunosuppressive treatments

    Time frame: Baseline and 6 months

    Immunosuppressive treatments description and changes

  7. Rejections

    Time frame: Baseline and 6 months

    Occurrence of rejection episodes

  8. Graft failure

    Time frame: Baseline and 6 months

    Occurrence of graf failure

  9. Adverse events

    Time frame: Baseline and 6 months

    Number of adverse events

  10. Infections

    Time frame: Baseline and 6 months

    Occurrence of infections

  11. Healthcare cost

    Time frame: 6 months

    Assess the healthcare cost (ER admission, hospitalizations)

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 15, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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